[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]
A PRESCRIPTION FOR SAFETY: THE NEED FOR H.R. 3880, THE INTERNET
PHARMACY CONSUMER PROTECTION ACT
=======================================================================
HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
SECOND SESSION
__________
MARCH 18, 2004
__________
Serial No. 108-169
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
______
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COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
DAN BURTON, Indiana HENRY A. WAXMAN, California
CHRISTOPHER SHAYS, Connecticut TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
MARK E. SOUDER, Indiana CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
DOUG OSE, California DENNIS J. KUCINICH, Ohio
RON LEWIS, Kentucky DANNY K. DAVIS, Illinois
JO ANN DAVIS, Virginia JOHN F. TIERNEY, Massachusetts
TODD RUSSELL PLATTS, Pennsylvania WM. LACY CLAY, Missouri
CHRIS CANNON, Utah DIANE E. WATSON, California
ADAM H. PUTNAM, Florida STEPHEN F. LYNCH, Massachusetts
EDWARD L. SCHROCK, Virginia CHRIS VAN HOLLEN, Maryland
JOHN J. DUNCAN, Jr., Tennessee LINDA T. SANCHEZ, California
NATHAN DEAL, Georgia C.A. ``DUTCH'' RUPPERSBERGER,
CANDICE S. MILLER, Michigan Maryland
TIM MURPHY, Pennsylvania ELEANOR HOLMES NORTON, District of
MICHAEL R. TURNER, Ohio Columbia
JOHN R. CARTER, Texas JIM COOPER, Tennessee
MARSHA BLACKBURN, Tennessee ------ ------
PATRICK J. TIBERI, Ohio ------
KATHERINE HARRIS, Florida BERNARD SANDERS, Vermont
(Independent)
Melissa Wojciak, Staff Director
David Marin, Deputy Staff Director/Communications Director
Rob Borden, Parliamentarian
Teresa Austin, Chief Clerk
Phil Barnett, Minority Chief of Staff/Chief Counsel
C O N T E N T S
----------
Page
Hearing held on March 18, 2004................................... 1
Statement of:
Hubbard, William K., Associate Commissioner for Policy and
Planning, Department of Health and Human Services,
accompanied by John M. Taylor III, Associate Commissioner
for Regulatory Affairs, Food and Drug Administration....... 23
Thompson, Dr. James, M.D., president and chief executive
officer, Federation of State Medical Boards of the United
States; Carmen A. Catizone, executive director/secretary,
National Association of Boards of Pharmacy; Jerry W.
Kilgore, attorney general, Commonwealth of Virginia; Dr.
Rebecca J. Patchin, M.D., trustee, American Medical
Association; and John M. Rector, senior vice president of
governmental affairs and general counsel, National
Community Pharmacists Association.......................... 52
Letters, statements, etc., submitted for the record by:
Catizone, Carmen A., executive director/secretary, National
Association of Boards of Pharmacy, prepared statement of... 61
Davis, Chairman Tom, a Representative in Congress from the
State of Virginia, prepared statement of................... 3
Hubbard, William K., Associate Commissioner for Policy and
Planning, Department of Health and Human Services, prepared
statement of............................................... 25
Kilgore, Jerry W., attorney general, Commonwealth of
Virginia, prepared statement of............................ 70
Maloney, Hon. Carolyn B., a Representative in Congress from
the State of New York, prepared statement of............... 110
Patchin, Dr. Rebecca J., M.D., trustee, American Medical
Association, prepared statement of......................... 74
Rector, John M., senior vice president of governmental
affairs and general counsel, National Community Pharmacists
Association, prepared statement of......................... 85
Thompson, Dr. James, M.D., president and chief executive
officer, Federation of State Medical Boards of the United
States, prepared statement of.............................. 55
Waxman, Hon. Henry A., a Representative in Congress from the
State of California, information concerning a Web page......... 19
A PRESCRIPTION FOR SAFETY: THE NEED FOR H.R. 3880, THE INTERNET
PHARMACY CONSUMER PROTECTION ACT
----------
THURSDAY, MARCH 18, 2004
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 10:17 a.m., in
room 2154, Rayburn House Office Building, Hon. Tom Davis of
Virginia (chairman of the committee) presiding.
Present: Representatives Tom Davis of Virginia, Shays,
Souder, Ose, Schrock, Duncan, Murphy, Turner, Carter, Harris,
Waxman, Towns, Clay, Watson, Van Hollen, and Norton.
Staff present: Melissa Wojciak, staff director; David
Marin, deputy staff director and director of communications;
Anne Marie Turner, counsel; Drew Crockett, deputy director of
communications; Teresa Austin, chief clerk; Brien Beattie,
deputy clerk; Susie Schulte, professional staff member; Corinne
Zaccagnini, chief information officer; Phil Barnett, minority
staff director; Kristin Amerling, minority deputy chief
counsel; Josh Sharfstein, minority professional staff member;
Earley Green, minority chief clerk; and Jean Gosa, minority
assistant clerk.
Chairman Tom Davis. Good morning. A quorum being present,
the Committee on Government Reform will come to order.
I'd like to welcome everybody to today's legislative
hearing on H.R. 3880, the Internet Pharmacy Consumer Protection
Act. This hearing will focus on how to curb, through
legislation, the growing sale of prescription drugs over the
Internet without a valid prescription.
Prescription drugs are well regulated in this country by a
system that includes pre-market approval by the FDA, State
licensure of health care practitioners who are allowed to
prescribe and State oversight of pharmacists and pharmacies.
However, as noted in previous committee hearings and recent
media reports, the Internet creates an easy environment for
illegitimate pharmacy Web sites to bypass traditional
regulations and established safeguards for the sale of
prescription drugs.
I think all of us here today have opened our in-boxes to
find dozens of e-mails advertising medications at low cost with
no prescriptions required. The risks of this kind of self-
medicating can include adverse reactions from inappropriately
prescribed medications, dangerous drug interactions, use of
counterfeit or tainted products and addiction to habit forming
substances.
Mr. Waxman and I recently introduced H.R. 3880, because too
many people are finding ways to obtain medications online
without valid prescriptions. And regulating those Internet
pharmacies can be a challenge for Federal and State enforcement
capabilities. H.R. 3880 amends the Food, Drug and Cosmetic Act
to address this problem in three steps.
First, the bill establishes disclosure standards for
Internet pharmacies. These Web sites are required to display
certain identifying information, including the name of the
business, pharmacist and physician associated with the Web
site. Second, the bill prohibits Internet sites from selling or
dispensing a prescription drug solely on the basis of an online
questionnaire. Online medical evaluations don't meet reasonable
standards of care and create risks for the consumers. And
third, the bill provides additional authority for States to
take actions against illegal Internet pharmacies. The bill
allows States attorneys general to file an injunction in
Federal court to shut down a rogue site across the country.
The need for legislation is critical. And I say this as
someone who is normally more than a little hesitant to regulate
the Internet or hinder commerce. The illegal diversion and
abuse of prescription drugs is becoming an increasingly serious
problem in this country. Last March, several of the witnesses
who are joining us again today highlighted this problem in
their testimony and asked for help from Congress. Mr. Waxman
and I gave it deliberate consideration and responded with
legislation to help protect consumers and aid Federal and State
enforcement and regulatory capabilities.
As we hold this discussion on the legislation today, it's
important to clarify that H.R. 3880 is intended to tackle
domestic Internet pharmacies that sell drugs without a valid
prescription. The bill is not intended to address international
pharmacies that sell drugs at a low cost to consumers who have
a valid prescription from their U.S. doctors. Although the
debate over reimportation is an important one, it's not the
focus of this hearing.
I want to thank our ranking member, Henry Waxman, for his
efforts and leadership on this legislation and his commitment
to public health. I would also like to thank our witnesses for
their participation today, and I look forward to their
testimony. I'm happy to extend a very specific welcome to my
good friend, Jerry Kilgore, who is the Attorney General of my
home State of Virginia, who's here today representing the
National Association of Attorneys General. Jerry, thanks for
being with us.
[The prepared statement of Chairman Tom Davis follows:]
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Chairman Tom Davis. I will now yield to Mr. Waxman for an
opening statement.
Mr. Waxman. I'd like to thank Chairman Davis for holding
this hearing today on how to stop domestic Web sites from
selling potentially dangerous medications without a valid
prescription. These Web sites occupy a dark and dangerous
corner of the U.S. health care system. But they are not hidden.
A simple e-mail may entice consumers, even children, to order
potentially dangerous drugs prescribed on the basis of a
cursory questionnaire by an anonymous physician.
In fact, just last night, one of my staff members, in
preparing for the hearing today, received an unsolicited e-mail
message offering overnight delivery of Viagra. I have a poster
over there that points out the Web site and that the e-mail was
linked to. This Web site offers many potentially dangerous
medications, including some controlled substances. The Web page
promises ``FDA approved drugs'' and states ``one of our U.S.
licensed physicians will review your request and issue
prescriptions for your medication.''
I would note that the Web page does not state that a
physician will determine whether this medication is right for
you. It does require that the user enter all credit card and
shipping information before any online consultation occurs.
[The information referred to follows:]
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Mr. Waxman. The growing number of illegitimate Internet
pharmacies has alarmed State medical boards. Yet States which
traditionally have regulated the practice of medicine and
pharmacy have been frustrated in their ability to shut these
sites down. One problem is that enforcement efforts are
complicated. A Web site operator can be in one State, the
pharmacy in a second State and the prescribing physician in a
third State. This may bring three different State standards
into play.
A second problem is that even when they are successful,
States typically can only obtain an injunction that keeps an
illegitimate site from selling to residents of that State
alone. And a third problem is that some State laws are too
vague to allow boards of medicine and pharmacy to quickly crack
down on these illegitimate sites.
When States cannot solve a national problem, it is
essential that the Federal Government step in. In this case,
however, the Department of Health and Human Services has been
reluctant to venture into an area traditionally handled by the
States absent clear direction from Congress. It's now time for
Congress to provide that clear direction. Last year, this
committee held an investigative hearing examining domestic
Internet pharmacies. At the hearing, individuals representing
State and medical pharmacy boards expressed support for
legislation that would create a Federal definition of valid
prescription for the purposes of Internet prescribing.
The Chief of Enforcement at the Food and Drug
Administration testified that such a standard would assist his
agency with shutting down illegitimate sites. And the chairman
of the Federal Trade Commission described a successful model in
the Federal Telemarketing Sales Act that permits States to work
with the Federal Government to protect consumers.
Since that hearing, we've worked together, Chairman Davis
and I, to craft a narrow, but effective legislative remedy. Our
bill, H.R. 3880, creates a single national standard for valid
prescription for Internet prescribing, by barring Web sites
from arranging prescriptions from doctors who have never seen
the patients. It also provides that Internet pharmacies make
basic disclosure of information to consumers, and it allows
State attorneys general to obtain nationwide injunctions
against illegal sites, avoiding the need for cumbersome State
by State enforcement.
Our philosophy with this bill is that less is more. We have
aimed to define the minimum Federal standard necessary to
accomplish our goal, and we have encouraged enforcement by the
States, the traditional regulators of medicine and pharmacy.
Our bill does not affect the separate question of reimportation
of prescription drugs, and it would not alter the practice of
telemedicine.
I look forward to hearing from the distinguished witnesses
today and to working with Chairman Davis and all the members of
this committee to improve this bill as necessary and move it
through the Congress. This is a good example of the legislative
process at its finest. After hearing from the witnesses at our
first hearing on the matter, we looked at what they had to say,
we heard what they suggested and we came up with a proposal.
Now today we'll hear reactions to these proposals. Those
reactions and the input help us make sure that we're working
together on a bipartisan basis to make the bill as good as it
possibly can be to protect the public interests.
I thank the chairman for setting the tone and working in
this way so that we can accomplish something that's important
for the American people.
Chairman Tom Davis. Thank you, Mr. Waxman.
Do any other members wish to make statements? The
gentlelady from the District of Columbia.
Ms. Norton. Mr. Chairman, I appreciate the way you and
Ranking Member Waxman have worked together to try to deal with
this relatively new phenomenon. It is also a new phenomenon in
our society that prescription drugs are advertised on the
media. In fact, some of the advertisements are truly laughable.
After trying to entice you to, in this country I suppose, go to
your doctor and get a prescription for XYZ drug, then they list
all the things it will do to hurt you. I guess that's because
of regulations of the FDA. So they become fodder for the late
night talk shows, all these miracle drugs are advertised along
with all the things they could do to harm you, so there will
not be liability, in case you don't understand that these drugs
have both good and bad effects.
But of course, if you go to your doctor, you're going to
find that out, and you're going to have a professional that
makes that judgment and advises you accordingly. But the
Internet has opened up a straight line path between the patient
and somebody somewhere who in fact will provide this drug that
perhaps you have seen on television that you think is exactly
what you need to do what you want, without any expert
intervention. This, I cannot, first of all, it amazes me that
this has gone on this long without some action at the Federal
level. I understand that States have tried to do something
about this. But this of course cries out for ICC, for the
commerce clause intervention of the Federal Government.
I say that I'm surprised that no catastrophe has occurred
with people ordering these drugs. I'm sure there has. If
problems have occurred, I can't imagine where the liability
would lie, or if in fact you would find somebody to sue and sue
successfully, especially since this goes on across
international boundaries. This has already gone on much too
long. We have no way of knowing, no way of knowing how many
people have been hurt. We do know this is a very enticing
temptation, particularly when the drugs are advertised on
legitimate television and you can eliminate some of the
difficulties, especially with the cost of health care, and
going to a doctor, by going straight to one of these Web sites
and perhaps doing yourself great harm.
Prescription drugs are the true miracle medicine for today,
because they do so much good, I think the time has come to make
sure we don't besmirch what these drugs can do by allowing this
matter to hang out there unattended. I thank you very much
again, Mr. Chairman, for this hearing.
Chairman Tom Davis. Thank you. Any other statements?
If not, we have our first panel. We have Mr. William
Hubbard, who is here testifying on behalf of the Food and Drug
Administration. Mr. Hubbard is the Associate Commissioner for
Policy and Planning. He is accompanied by Mr. John M. Taylor,
III, the Associate Commissioner for Regulatory Affairs. Mr.
Taylor will be available to respond to questions posed by
Members.
It is the policy of this Committee to swear in all
witnesses before they testify. Would you stand with me and
raise your right hands?
[Witnesses sworn.]
Chairman Tom Davis. Thank you.
Mr. Hubbard, your entire statement is a part of the record.
What we would like you to do is try to keep it to 5 minutes. We
have a light in front of you, when it turns orange, it means 4
minutes are up and when it turns red 5 are up, and try to move
to summary, because our questions are based on your entire
testimony.
We welcome you and thank you for being with us. You too,
Mr. Taylor.
STATEMENT OF WILLIAM K. HUBBARD, ASSOCIATE COMMISSIONER FOR
POLICY AND PLANNING, DEPARTMENT OF HEALTH AND HUMAN SERVICES,
ACCOMPANIED BY JOHN M. TAYLOR III, ASSOCIATE COMMISSIONER FOR
REGULATORY AFFAIRS, FOOD AND DRUG ADMINISTRATION
Mr. Hubbard. Thank you, Mr. Chairman. As you say, I do have
a written testimony.
I will just make a few brief remarks. We thank the
committee for holding this hearing. We believe you are
recognizing a significant public health threat from unregulated
Internet sites. The Internet sales of drugs are a wonderful
tool for pharmacists and patients and physicians to use.
However, only when they're properly operated and regulated, and
as you are pointing out, many of these are not.
The public health threat, we believe, is real when patients
unknowingly purchase these drugs from unknown Web sites. And
the disclosure concept that you have recognized we believe is
an important one.
We appreciate that the committee is trying to identify some
solutions to this problem, who and where these sites are,
whether they are licensed, whether they use one of these
dubious questionnaires. The concept of the intermediary is
clearly very important in the prescribing of drugs, and these
sites often do skirt that.
FDA often monitors the Internet, and one of the sites that
we've just noticed very recently I'd like to point out to the
committee, if I could ask the clerk to bring it up to the
Chair. This site is quite interesting, because we believe it is
emblematic of some of the things that your bill is attempting
to do and the committee is recognizing.
As speakers on the committee pointed out, many Americans
get e-mails offering to sell prescription drugs. This
particular site, and there's a poster of it over here against
the wall, offers to sell generic drugs. These particular
generic drugs or alleged generic drugs do not have generic
versions. So we decided to investigate that a bit more.
So we did a check on the location of the actual Internet
site and found that it was in China, in Xiandong Province,
China. We thought they might be selling Chinese counterfeits.
So we actually made a purchase. When the drug arrived, as
you'll see on the envelope there, it has a return address of
Miami, FL. Yet the postmark, you may notice, is Dallas, TX.
Then there's a return address, if someone needs to reorder, in
the package that suggests that the person should contact
someone in the country of Belize. Then there's an 800 number
which we called, and the person there said they were located in
the United States. When we called back a second time, they said
they were in Belize.
We ordered three drugs, Ambien, a controlled substance,
it's a sleep aid, Viagra and Lipitor. And we noted on the so-
called online questionnaire that we were taking erythromycin.
Erythromycin is a drug that's contraindicated for Lipitor. So
here you have the kind of situation the committee is pointing
out, you've got a so-called questionnaire in which the patient
has a consultation with some potential physician in another
country, and you've got a lack of disclosure, and in fact, this
site has so many convoluted potential sources that we don't
know where it is.
So the disclosure concept that is embodied in the bill we
believe would address these sorts of issues of the sites not
being where anyone knows about, and allowing people to buy or
get a drug that has no true prescription with it, there's not
really a doctor at the other end that sees the patient,
diagnoses the patient and makes a rational prescription for the
patient.
So with that, Mr. Taylor and I will be happy to take
questions.
[The prepared statement of Mr. Hubbard follows:]
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Chairman Tom Davis. Thank you very much. I apologize, the
vice president was on the phone and I had to have Ms. Harris
ably take the Chair while I was there. I apologize for leaving
in the middle of your testimony. I did read it last night,
though.
Let me start the questioning. Historically, States have
been the primary enforcement authority with respect to the
practice of medicine and the dispensing of prescription drugs.
How do you find that appropriate balance? And of course, the
Internet raises a whole new paradigm for us in terms of how you
do this, because it's so ubiquitous.
Mr. Hubbard. And many people have pointed out, because the
Internet crosses State lines, it's more difficult for States to
enforce in these kinds of cases you have pointed out. Congress
has given FDA the authority to regulate the practice of
medicine in only one case that I'm familiar with. And the FDA
itself has been reluctant to step into the regulation of the
practice of medicine, which has been a State responsibility.
Here you are identifying the potential need, perhaps, to take
one more step into that with the definition of a valid
prescription. And we certainly understand your thinking in
doing so.
Chairman Tom Davis. Both the AMA and the FSMB have
guidelines that stipulate an appropriate medical relationship
between the patient and physician must exist before a
prescription is written and dispensed. AMA and the FSMB define
this relationship to include a documented patient evaluation,
including medical history and a physical examination.
Do you agree these recommendations are also consistent with
the language in H.R. 3880?
Mr. Hubbard. I believe they are, Mr. Chairman.
Chairman Tom Davis. Mr. Taylor, do you agree with that,
too?
Mr. Taylor. Yes.
Chairman Tom Davis. Mr. Taylor, at the hearing last March,
you stated that a Federal standard for what constitutes a valid
prescription would aid enforcement capabilities. Are you still
of that opinion?
Mr. Taylor. I did acknowledge that. To put it in context, I
think what I said last year was, a part of the complementary
enforcement role of the States and Federal Government, we were
often relying upon the State medical boards or boards of
pharmacy to inform us what the proper standard of medical care
is within a particular State. So when we're building a case and
there are differences from State to State, that raises some
challenges, absolutely.
Chairman Tom Davis. FDA has indicated, in your testimony,
that it has the legal authority to take action against the sale
of dispensing a prescription drug without a valid prescription.
How often has the FDA used this authority to take action
against rogue Internet pharmacy sites?
Mr. Taylor. I can give you a recent example. Yesterday, we
announced that we had brought indictment against an Internet
pharmacy site, where indeed one of the charges was the fact
that the product was being dispensed in a manner that was
outside the proper standard of care, standard of medical care
and the standard of pharmacy in that particular State.
It's often an element of our criminal cases, what we will
do is consult with the States, figure out what the standard is
within that State and make that one of the charges. What we've
seen in many cases, especially two recent criminal cases, is
that there often have been attempts by those who have been
indicted to either hide the identity of those physicians that
are supposed to be giving proper care, or misrepresenting the
fact that they are licensed within a State, when in actuality
they are not.
So it's often a component of the cases that we bring.
Mr. Hubbard. And Mr. Chairman, while we can do in some
States that have explicit laws, there are many, many States, in
fact the majority of States, where the State law does not
explicitly define it in a way that FDA can use its authority.
Chairman Tom Davis. Mr. Taylor, also in the March hearing,
you noted that you couldn't name a single State that qualifies
the use of an online questionnaire as a legitimate or
appropriate medical relationship. Do you agree that online
medical questionnaires don't constitute an adequate or
appropriate medical relationship?
Mr. Taylor. Let me refine that answer. I'm aware of
approximately 27 States that generally disallow Internet
prescribing. I think 7 of those States do so by explicit
statute, I think 12 do so based on medical board policy, and
another 8 do so based on medical board rulings. There are
another 13 States that have chosen to make a determination that
Internet prescribing is impermissible.
So now there are approximately 40 States that have taken a
position that there is some means as to what constitutes proper
Internet prescribing, and an online questionnaire falls outside
that arena. Mr. Chairman, one of the things that's changed in
the 5 years that we've been dealing with the Internet is the
fact that both on the Federal Government level and the State
government level, our statutes did not, quite frankly did not
contemplate this type of practice.
As time has gone by, the States have taken steps to address
it expressly through the medical boards and through their
boards of pharmacy. That's why today we have 40 States that
have taken some stance. That has obviously enhanced our
enforcement efforts on the Federal level, too. So things have
changed a little since last year.
Chairman Tom Davis. AMA's testimony today highlights the
need for something to be done at the Federal level to address
the myriad problems associated with the illegal use of Internet
pharmacies. Do you agree with them?
Mr. Taylor. Well, I mean, traditionally the regulation of,
or what constitutes a proper medical standard or what
constitutes a proper or valid prescription is something that
has resided at the State level. I think to the extent that
there is going to be any change in that position, it needs to
be done very carefully.
Chairman Tom Davis. OK. Thank you very much.
Mr. Waxman.
Mr. Waxman. Thank you, Mr. Chairman.
Mr. Hubbard, in your written testimony today, you expressed
FDA's concern about the proliferation of sites that substitute
a simple online questionnaire for a face to face examination
and patient supervision by a health care practitioner. Let's
assume for the moment that some of these Web sites employ
licensed physicians to write the prescription on the basis of
the questionnaire.
When assessing whether these prescriptions are valid, does
FDA rely on a single Federal definition or defer to the States?
Mr. Hubbard. We defer to the States.
Mr. Waxman. Are all State definitions alike?
Mr. Hubbard. No, they are not, Mr. Waxman.
Mr. Waxman. Do the varying definitions complicate
enforcement actions?
Mr. Hubbard. No question.
Mr. Waxman. H.R. 3880 would solve this problem by creating
a single national standard for what is a valid prescription
related to Internet pharmacies. We're going to hear from the
Virginia State Attorney General on behalf of the National
Association of Attorneys General and the Federation of State
Medical Boards and the National Association of Board of
Pharmacy are going to endorse such a standard.
Why do you think these key State organizations support
having a single Federal standard for prescription related to
Internet prescribing?
Mr. Hubbard. When the Internet emerged as a tool of this
nature, drug prescribing became obvious at that time. I believe
the States thought they could, using their existing authority
over physicians and pharmacies, appropriately regulate these
businesses.
They realized fairly quickly, I think by the year 2000,
that because these sites would be located in one State but the
patient in another that they would be unable to do so, and you
needed, in their view, and I believe they will express that for
themselves, as I understand it, they expressed the view that
you needed some sort of a more uniform national standard. I
believe they are supportive of that today.
Mr. Waxman. So it seems that a single national standard is
needed to address these rogue Web sites?
Mr. Hubbard. It's certainly their opinion.
Mr. Waxman. Our legislation provides this standard, while
maintaining the key enforcement role for the States, as you
well know. Thank you very much for your testimony, both of you,
and thank you, Mr. Chairman.
Chairman Tom Davis. Thank you very much. Mr. Shays.
Mr. Shays. I'll pass, thank you, Mr. Chairman.
Chairman Tom Davis. Any other questions on this side? The
gentleman from Tennessee.
Mr. Duncan. Mr. Hubbard, as the chairman pointed out in his
first question, the primary enforcement role for prescribing
drugs is up to the States. But of course, the Internet does not
recognize State lines or moves across State lines, so it's a
difficult thing for States to enforce this totally.
I'm just curious, how fast are these Internet prescriptions
growing? Do we have any estimate of that? All the articles you
read, they say it's growing very fast. But I just wondered if
you have any statistics of how many prescriptions are being
issued over the Internet now.
Mr. Hubbard. There's no certainty here. There are clearly
estimates made by various groups. I think the National
Association of Boards of Pharmacy has recognized at least 200.
There are many more foreign sites. We did a computer search
just last week for one particular set from one country, and
this is the list. There's well over 1,000 here. And that's just
one locality. So worldwide, there may be----
Mr. Duncan. Is that 1,000 prescriptions?
Mr. Hubbard. It's 1,000 different Web sites offering to
sell drugs in the kinds of ways that the committee is
recognizing.
Mr. Duncan. I see. And do you know of instances where
children have been getting these drugs over the Internet? Have
you heard about that?
Mr. Hubbard. Certainly there are drugs that children used
being prescribed. There's a wide, wide range of drugs being
prescribed. Some sites limit themselves to just a few lifestyle
drugs like Viagra, but many sites sell a list of hundreds of
different drugs.
Mr. Duncan. Have you been getting reports of people who
have been injured or been hurt or made sick or have been ripped
off by these prescriptions?
Mr. Hubbard. We do have reports. Unfortunately, they are
relatively sporadic. They depend on a patient who's injured
reporting to us. There's no good system for tracking some of
these drugs that are sold illegally. Because the medical system
is designed to track systems that are properly prescribed and
dispensed by licensed pharmacies in the United States.
Mr. Duncan. I know it's difficult, but have you had 100
instances or 1,000?
Mr. Taylor. I can't give you a number, but I can give you a
tangible example. Last summer, and the agency is continuing to
investigate this, but last summer we had to assist in the
recalling of over 200,000 bottles of Lipitor, because we
discovered that it had been counterfeit. Obviously the
benefit----
Mr. Duncan. Where was that?
Mr. Taylor. I'm sorry?
Mr. Duncan. Where was that you recalled----
Mr. Taylor. Actually, by the time the recall was finished,
the counterfeit Lipitor had spread throughout the country. In
some cases it was available through a brick and mortar
pharmacy, but in other cases it was available over the
Internet. The reason I used it as an example is because
obviously the benefit of Lipitor is its cholesterol lowering
properties. And one of the----
Mr. Duncan. Was that Lipitor being sold by one Internet
site or many?
Mr. Taylor. It's not clear how many sites it was sold over,
but we did get consumer complaints suggesting that it was at
least sold over two. What happened is when we put out the
original talk paper warning the public about the fact that we
had discovered this product, we began to get reports from
people. A couple of people reported purchasing it over the
Internet.
So I don't know how many Internet sites it was available
at, but that's a tangible situation where someone was
purchasing a product thinking they were getting cholesterol
lowering properties, and because of the nature of the product,
not only were they not necessarily getting the cholesterol
lowering properties, you could argue that indeed they were
being ripped off, because they were paying for something that
they didn't actually get.
Mr. Hubbard. Let me give you an example, Mr. Duncan. I've
got one site here, there are 400 different Web sites, when we
checked them, they are all the same business. The same
individual runs them, from a small New England town. But they
all have different names, and they're targeted at citizens in
different countries, Houston, Phoenix, wherever. So the citizen
thinks that's a local business in his hometown selling legal
American drugs. In fact, it's one business in New England
saying 400 times in 400 cities, we're legitimate, we're legal
and we'll give you a drug if you'll fill out a questionnaire.
Mr. Duncan. OK, well, thank you very much.
Mr. Hubbard. You're welcome.
Chairman Tom Davis. Thank you very much. Ms. Watson, any
questions?
Ms. Watson. I'm waiting on a copy of the bill, Mr.
Chairman. But in the bill, this is a question to the Chair,
does it require a legitimate prescription from the doctor and
how is that checked out? You send this, if there's a
requirement by the company, you send that in, how do they check
it out to be sure it's valid?
Chairman Tom Davis. A valid prescription is required to
exist. But we go further to define an adequate medical
relationship, so that the person who is prescribing it has done
an appropriate examination and taken the history and has had a
meeting with the person, as opposed to calling up and a doctor
just writing a prescription because you're willing to pay
money. That's what's critical in these cases. A lot of these
Web sites have people who will sign prescriptions but they know
nothing about the people who are taking the drugs, what they're
interacting with, and that's where the danger occurs.
Ms. Watson. Let me ask Mr. Hubbard, certainly each State
differs from the other. What would be the standard positions
that you would like to see in a piece of legislation that would
be able to monitor the abuse of the Internet prescriptions?
Mr. Hubbard. As Chairman Davis said, FDA has a requirement
that there be a valid prescription. That's Federal law.
Ms. Watson. Yes.
Mr. Hubbard. But then FDA relies upon each State to
determine whether a given prescription in that State is valid.
Ms. Watson. Who's the watchdog?
Mr. Hubbard. Well, in the case of prescriptions, it's
actually the State medical boards and pharmacy boards, not the
FDA. Federal law does have a requirement that there be a valid
prescription, but each State then determines what that is.
Ms. Watson. Question to the Chair, I haven't read the
legislation yet. But is there a requirement that each State
indicate who the watchdog agency is and what they watch for?
Mr. Hubbard. I believe it's very clear, Ms. Watson, that
the State pharmacy and medical boards have that responsibility.
They accept that responsibility. But what they're saying is
that they can't utilize their law if the Web site is in another
State, because they can't prosecute across State lines.
Ms. Watson. So how do we at the Federal level get to that
issue? That's the crux of this question, and maybe this is to
the author.
Chairman Tom Davis. What happens in this case is we define
an appropriate medical relationship. That's where this stuff
goes afoul. They can produce a doctor's note on this, a
doctor's prescription, but there's no relationship. It's almost
like an auto pen. There is no appropriate medical relationship,
as we define the appropriate medical relationship. It would be
up to the State and their enforcement actions to go there, and
the burden would be on the people who are dispensing this to
prove they had the relationship, which of course they don't, in
many of these cases.
Ms. Watson. Who oversees that, the FDA? Or the State
attorney general?
Mr. Taylor. Just to give you an example, there have
certainly been instances where more than one State has
recognized behavior that they deemed to be problematic. What
the States have been able to do is bring some type of action
that is confined to their State boundaries. But what we've also
tried to do is work closely with them so that we, the Federal
Government, could bring a case that is more global in nature
and is complementary to the case that the State is bringing, so
there's a more comprehensive approach to dealing with
problematic conduct that might be going beyond State lines.
So there is a way to do it.
Chairman Tom Davis. Let me try to help you. Our bill
allows, the new enforcement authority that we give in this case
is modeled on the Federal Telemarketing Sales Act. So we have
an appropriate Federal model on this. That allows the State
attorney general to shut down a rogue site across the country
rather than only bar sales to customers or consumers in his or
her State.
Ms. Watson. If the Internet shows a location down in
Central America for controlled drugs, who then is--I see
somebody shaking their head--who then is in charge of
overseeing that on the Internet?
Mr. Taylor. For controlled substances the Drug Enforcement
Administration has primarily jurisdiction over controlled
substances. However, the FDA and the States will often work,
again with DEA, to help bring cases if we determine that those
products that are being marketed through the Web site that's
listed in Central America are actually making their way to the
United States.
Ms. Watson. May I ask who determines that? How is it
triggered? How does the process start?
Mr. Taylor. Usually it's triggered based on the working
relationships that we've established over the years. We've been
at this for about 4 or 5 years. We recognized fairly early on
that none of us quite frankly had either the resources or the
expertise to do it ourselves. So over the last 4 or 5 years,
we've tried to work closely with both our Federal and State
partners that we could work together on a real time basis to
address these situations when they come to our attention.
So it's really through our partnerships and working
relationships. And over time, they've proved to be quite
successful. So that's usually how it's done.
Chairman Tom Davis. Thank you. Time has expired. Thank you
very much.
The gentleman from Connecticut, Mr. Shays.
Mr. Shays. Thank you, Mr. Chairman.
Mr. Chairman, thank you and Mr. Waxman for highlighting
this issue, thank you for having this hearing, thank you for
coming forward with the legislation that we can consider. In my
earlier life I used to chair the subcommittee of this full
committee that oversaw the FDA. And I appreciate so much what
FDA has to contend with.
At the same time, I do have some issues that I want to ask.
We talk about the questionnaire that has to be filled out for
the Web site. I sent a questionnaire to my constituents. And I
had one where I gave a statement, I said strongly agree,
somewhat agree, no opinion, somewhat disagree, strongly
disagree. This was the statement. Americans should be able to
import less costly FDA approved prescription drugs from Canada.
I had an intuitive sense that they would probably agree;
62.7 percent strongly agree, 20.4 percent agree, 83.1 percent
of my constituents believe that they should be able to import
less costly FDA approved prescription drugs from Canada. Does
that statistic surprise you?
Mr. Hubbard. Not at all.
Ms. Shays. The issue is, that's illegal right now?
Mr. Hubbard. Absolutely.
Ms. Shays. Constituents are doing it, correct?
Mr. Hubbard. Absolutely.
Mr. Shays. I'm told the drug companies have basically
exported to Canada or allowed to come into Canada basically
seven times what Canada consumes, and it's a growing market.
How would you begin to even reign in this illegal activity in
Canada? Not that I even know if I want you to, frankly. I'm
having to deal with it.
Mr. Hubbard. We cannot, under current law. The current law
was established for FDA to inspect a very large volume of an
imported drug, say, millions of pills that Pfizer might bring
in from a plant in Ireland. And that process worked very well.
But when individuals buy these small 60 or 90 day supplies, and
it comes in huge quantities to the mail facilities in this
country, neither the Postal Service nor Customs nor the DEA nor
FDA can in any rational way look at all those products and make
any judgments about whether they're good or not.
Mr. Shays. Who's breaking the law? Is Canada breaking the
law in exporting them, or are my constituents breaking the law
when they buy them?
Mr. Hubbard. It may be a violation of Canadian law, but
that is would be for them to determine. The drugs themselves
are clearly illegal. FDA, though, has never taken enforcement
action----
Mr. Shays. But listen to my question. My question is, who's
breaking the law in the United States?
Mr. Hubbard. On some technical level you could argue that
the patient is breaking the law by buying those drugs, but the
FDA has never attempted to punish a patient for buying drugs.
Mr. Shays. So the reality is, whatever we do, we still have
that issue out there?
Mr. Hubbard. The implication issue, as the chairman said at
the outset, will still be there.
Mr. Shays. And we need to bring some census, both here and
overseas. But what I'm wrestling with is, I happen to believe
that people should be able to import drugs if they're FDA
approved. And what I also wonder about is, these aren't drugs
necessarily made in the United States then sent to Canada,
they're sometimes made elsewhere and sent to Canada, just as
they would be sent to the United States.
Tell me the logic of why my constituents shouldn't be
allowed to buy the same drug, and if they can buy it overseas
for less, why they shouldn't be able to?
Mr. Hubbard. Because, Mr. Shays, the assumption people make
that those drugs are all U.S. made, high quality drugs, just
coming back, is wrong in our view.
Mr. Shays. Does it matter if it's U.S. made? But they make
an assumption that the drugs they buy here are U.S. made, and
they are. So I don't get your point.
Mr. Hubbard. If you buy a drug here, it's been made in an
FDA inspected facility under very strict FDA manufacturing
controls. These foreign drugs in many cases do not meet those
criteria. So that's the problem. The patient can't make a
determination whether they're getting that U.S. made drug you
describe or the other drug.
Mr. Shays. Do we have statistics that tell us that the
drugs they're buying from Canada are mostly not FDA approved?
Mr. Hubbard. Mr. Taylor can describe a process of screening
these shipments. He's done two of those recently that found the
vast majority of these actual shipments from Canada are not FDA
approved drugs.
Mr. Shays. OK. So just tell me the statistics. I don't need
to know the process.
Mr. Taylor. Sir, I'm not sure we have good statistics.
We've tried to determine the percentage, as have others. But
the bottom line is that we do believe that as demand here
increases, or at least our fear is that as demand here in the
United States increases, that the Canadian pharmacies that we
now see will get their product from sources that are less
reputable than the sources----
Mr. Shays. But you're not listening to my question. My
question is, do you have statistics that say that the vast
majority of the drugs, you're saying it, but you're not
giving----
Mr. Hubbard. We have sampling statistics, yes.
Mr. Shays. What is the statistic, that 90 percent, 50
percent, 20 percent, 80 percent, what is it?
Mr. Hubbard. Well, it's certainly over 90----
Mr. Shays. No, no, wait, wait----
Mr. Taylor. What the blitz showed was that 70 to 90 percent
of the products that were being imported were unapproved. We do
not have data----
Mr. Shays. Unapproved means not FDA approved?
Mr. Taylor. Correct. But we do not have data that tells us
how much of the product is manufactured in Canada versus
manufactured in England versus manufactured in Asia.
Mr. Shays. Let me just finish this by just making a
comment. I know my light is on. This is hugely important, that
people buy drugs actually need the drugs they buy and have been
shown by a medical professional to need them. My only point is
that we're saying this isn't illegal, this is illegal from the
United States, but we're not enforcing it. And you have
ambivalence in Congress on this law. This is a huge, gigantic
issue that's just only going to get bigger.
With all due respect to your work, we don't have
statistics. We're making claims that we can't back up with
statistics.
Mr. Taylor. May I respond, sir?
Mr. Shays. Sure.
Mr. Taylor. We do not have statistics, but we certainly
have tangible information. For example, your first question
relating to what you should tell your constituents or why your
constituents should be concerned about purchasing products over
the Internet, 3 weeks ago, and I know this isn't about the----
Mr. Shays. Can I tell you this? I don't want to keep--my
red light is on. But your bottom line is you don't have
statistics right now. If I have a second round I would be happy
to get more information.
Chairman Tom Davis. Let me just note again, I mean, this is
an important issue. But the bill really tackles domestic
Internet pharmacies. We don't really go after the other.
Mr. Taylor. That's right. My point was that someone
purchased contraceptive patches over an Internet site that she
thought was a U.S. Internet site. In actuality, she received
contraceptive patches that had no active ingredient in them. By
the time we completed--and we're not done with our criminal
investigation yet--but by the time we completed that
investigation, sir, the origin of those patches turned out to
be India. We had to actually track through about five or six
different sites to determine the origin of the product.
So my only point is that the reason why people need to be
concerned is that even though it appears that you're getting an
FDA approved product, we do have tangible examples of where
people have not received what they wished or hoped that they
had purchased. And it was a consumer complaint by this
particular consumer that led us to the discovery. What we did
is we warned consumers to beware of other products purchased on
these sites.
We were not saying that all sites are bad, but we had
tangible proof that these were problematic sites and we warned
the public that they needed to be careful and talk and consult
with their health care practitioner when making a decision
whether or not to purchase over some of these sites.
Chairman Tom Davis. Thank you.
Let me just ask if any other Members have questions for
this panel. Mr. Murphy.
Mr. Murphy. Thank you, Mr. Chairman. I also compliment you
and Mr. Waxman for moving forward on this important
legislation. This is rather urgent, because it is such a major
issue with regard to abuse and use of the system for doing
this.
I want to ask a couple of things. First of all, the
physicians who are involved with prescribing these drugs at the
other end of the Web site, in some cases they may not be
physicians at all, and in some cases, from other State or other
countries, they're not open to any liability at all if they
mis-prescribe, if they do not take an accurate history, they're
not open to any liability, am I correct in that?
Mr. Hubbard. The next panel may be better set to answer
that question. But certainly we have pointed out that liability
concerns must exist here in these cases, because you've got
people doing things that are either outside the law or not
proper medical practice.
Mr. Taylor. And sir, if we can determine that those
physicians are a part of a criminal conspiracy, because in some
cases, the physicians have an agreement with the Internet
pharmacy that's supplying those products, we do include them as
part of the defendants in our criminal cases. So they do incur
some criminal liability.
Mr. Murphy. Another question I have with regard to FDA, is
there any requirement for pharmaceutical manufacturers to only
sell prescription medication to legitimate distributors who
will ascribe to some sort of other laws or code of ethics with
regard to how those medications will be distributed?
Mr. Hubbard. Well, in fact, we've been working with the
wholesalers and distributors and manufacturers this year to set
up standards by which wholesalers will assure, and
manufacturers can assure that they are selling to legitimate
wholesalers and that the proper questions get asked about where
the drug came from. There are some instances in which
wholesalers will buy from somewhat fly by night sellers of
drugs who offer a deep discount. And that is a way for
counterfeit drugs to get into the system.
Mr. Murphy. There is something I want to bring to the
committee's attention, too, another important aspect of this,
and that has to do with, even when a physician has face to face
contact with a patient, particularly the elderly, there was a
recent CDC study, the National Ambulatory Medical Care Survey
did a study in which they reported that at least one drug
considered inappropriate by experts was prescribed at 7.8
percent of elderly patient visits. That's some 16 million
visits a year. This one drug classified as never or rarely
appropriate was prescribed nearly 4 percent of the time.
There's a massive amount of medication errors that occur,
even when a physician is face to face with an elderly patient.
When I look at the charts here of what is available online,
particularly some of the anti-depression and pain relief drugs
that may have side effects, such as dizziness, etc., nothing is
more fearful to an elderly person than falling down, having a
hip injury, being hospitalized and having subsequent problems
with that.
I cannot possibly imagine a scenario by which someone would
be self-prescribing these things in any sort of a way that's
actually good for their health. I understand situations in
which a patient is seeing a physician and has received a
prescription from a physician, a legitimate physician in their
area. But I do worry about people self-prescribing, and that is
a huge concern. Relatives may say, let's help Mom or let's help
Grandma. Here is something that we know helped someone else,
let's pursue that.
The consequences can be extremely harmful and deadly. Some
1 in 8 emergency room visits in this country are medication
errors; 1 in 12 hospital admissions are related to medication
errors. And those are when patients are seeing physicians.
So moving forward on legislation such as this is extremely
important. However, under the circumstances where a person is
seeing a physician it's helpful. But under the circumstances
where someone is still trying to self-prescribe or obtain drugs
in unscrupulous manners and use that, I'm very, very worried
that there's almost nothing we can do to prevent that. Am I
correct?
Mr. Hubbard. You're absolutely correct, Mr. Murphy. Someone
could say on one of these questionnaires, I have hypertension,
high blood pressure, when in fact they have hypotension, low
blood pressure. And they could order exactly the wrong drug,
because the patient is making that decision without the
doctor's involvement. Because we don't believe in many cases
there is a doctor at the other end, and they certainly don't
seem to be asking the right questions of the patient, and
they're certainly not meeting and seeing the patient and
checking their blood pressure and all that.
So you're absolutely right. This is a problem that needs to
be fixed.
Mr. Murphy. On these, do they know the other medication the
patient may be on?
Mr. Hubbard. It purports to ask some of those questions----
Mr. Murphy. But they may not know them all, because
patients themselves may not know.
Mr. Hubbard. One of the things we did here, we ordered a
drug that is contraindicated to be taken with a different drug
called erythromycin. So we said that on the questionnaire, we
said, I'm taking erythromycin, and we ordered Lipitor. They
sent the Lipitor anyway.
So it appears they didn't even bother to read the
questionnaire. It appears in some cases these questionnaires
are merely there as a facade anyway.
Mr. Taylor. And just to add to that, I think we need to
keep in mind there are also different types of questionnaires.
There are some questionnaires that are basically all filled in
for you, all you have to do is insert your name and your
address, and that's it. There are other questionnaires that
ostensibly pretend to get all the relevant information, but at
the end of the day, as you noted, because there isn't really
the proper health care practitioner-patient interaction, you're
absolutely right, that there might be critical information that
should be gleaned from the patient that is not done. That puts
the patient at potential harm.
Mr. Murphy. My hope is we continue on with these hearings
and move forward with this legislation, that Americans will pay
attention to the idea that seeing a physician face to face has
some room for medication error there alone. Self-prescribing
and going to sites that are illegitimate is downright dangerous
and deadly, and people have to avoid those sorts of sites,
because that is something that is going to end up killing and
harming a lot of Americans. Thank you.
Mr. Hubbard. We agree, Mr. Murphy.
Chairman Tom Davis. Thank you. Are there any other
members--Mr. Carter, any questions? No other questions. I don't
have any others. Mr. Shays, did you want to ask a followup?
Mr. Shays. If someone is sent a drug that they didn't have
a prescription for and they were to become ill or die, could
the pharmaceutical or the Internet organization be found
guilty?
Chairman Tom Davis. If you can find them.
Mr. Hubbard. I think you're talking about a tort liability
question. We certainly have raised those questions in the case
of some businesses that are promoting these. It's not really an
FDA question. But one would assume that there would be some
liability there.
Mr. Shays. I'm struck by the fact that this is so stunning
that I didn't know, I mean, not that many of us didn't know,
but I'm astounded that I didn't know that you could get
something without having some kind of prescription. It tells me
frankly that you all have a responsibility as well. The mere
fact that I asked you a question about that issue, it would
seem to me that FDA needs to be much more proactive.
And they're going to have to, I think, sort out, rather
than saying, you know, what's happening in Canada is illegal,
but it's still going to continue. I happen to want to make it
legal. I don't like people breaking the law, but I want to make
it legal in a way that works. But I want to do what the
chairman wants to do. And I just appreciate that he's made this
an issue that we need to be more aware of.
But I'm saying as well, I think you all have a
responsibility to be a lot more proactive on this.
Mr. Hubbard. Fair enough, sir.
Chairman Tom Davis. Thank you. Let me thank this panel very
much. We appreciate your questions. Obviously when we get you
up here we're going to ask you a lot of things that Members
have questions about. But that's not new to you.
Mr. Hubbard. Thank you, Mr. Chairman.
Chairman Tom Davis. We appreciate your insights on the
bill. Thank you very much.
We're going to move to our second panel. We have Dr. Jim
Thompson, of the Federation of State Medical Boards; Dr. Carmen
Catizone, of the National Association of Boards of Pharmacy;
Virginia Attorney General Jerry Kilgore; Dr. Rebecca Patchin of
the American Medical Association; and representing the National
Community Pharmacists Association, Mr. John Rector.
We may have votes, we're going to try to get through
everybody's testimony, we may have votes and have to take a
brief recess in between. I hope everybody's time can
accommodate that. But I will swear everybody in and we'll start
the testimony and get as far as we can before we have votes.
Please rise with me and raise your right hands.
[Witnesses sworn.]
Chairman Tom Davis. Thank you very much.
Dr. Thompson, we'll start with you and move straight down.
STATEMENTS OF DR. JAMES THOMPSON, M.D., PRESIDENT AND CHIEF
EXECUTIVE OFFICER, FEDERATION OF STATE MEDICAL BOARDS OF THE
UNITED STATES; CARMEN A. CATIZONE, EXECUTIVE DIRECTOR/
SECRETARY, NATIONAL ASSOCIATION OF BOARDS OF PHARMACY; JERRY W.
KILGORE, ATTORNEY GENERAL, COMMONWEALTH OF VIRGINIA; DR.
REBECCA J. PATCHIN, M.D., TRUSTEE, AMERICAN MEDICAL
ASSOCIATION; AND JOHN M. RECTOR, SENIOR VICE PRESIDENT OF
GOVERNMENTAL AFFAIRS AND GENERAL COUNSEL, NATIONAL COMMUNITY
PHARMACISTS ASSOCIATION
Dr. Thompson. Thank you and good morning to members of the
committee.
I'm Dr. James Thompson, I'm president and CEO of the
Federation of State Medical Boards of the United States. The
Federation is a national, non-profit association established in
1912 which serves as a collective voice for its 70 member State
medical licensing and disciplinary boards. The Federation's
primary mission is to improve the quality, safety and integrity
of health care by promoting high standards for physician
licensure and practice, as well as supporting and assisting
State medical boards and the protection of the public.
As I indicated at the hearing this committee held in March
2003, the Federation has been actively involved as a national
leader in the use of telecommunications and the Internet in the
practice of medicine for a number of years. In 1996, the
Federation published a model act to regulate the practice of
medicine across State lines. In 2000, it published guidelines
for Internet prescribing. In 2002, it published model
guidelines for the appropriate use of the Internet in medical
practice, one of the first national standards established for
Internet medical practice.
Those guidelines which the Federation recommends be adopted
by State medical boards include a key provision, and I'll quote
from that provision, a documented patient evaluation, including
history and physical evaluation adequate to establish diagnoses
and identify underlying conditions and/or contraindications to
the treatment recommended and provided must be obtained prior
to providing treatment, including issuing prescriptions
electronically or otherwise.
This has been the key interest of the Federation with
respect to Internet pharmacies. There must be an appropriate
relationship between the patient and the physician before a
prescription is written and medication dispensed. In addition
to issuing these guidelines, the Federation has aggressively
sought to identify Internet pharmacies that are dispensing
drugs on the basis of prescriptions written by health care
providers whose relationship with the patient does not appear
to meet minimal standards.
In September 2000, the Federation of State Medical Boards
established the national clearinghouse on Internet prescribing
to collect and disseminate information on rogue Internet sites
offering prescribing and dispensing services for prescription
drugs to consumers. The clearinghouse is uniquely qualified to
coordinate information between regulatory and enforcement
entities because of its formal relationship with all the State
medical boards in the United States and its territories and its
well established lines of communication with State and Federal
regulatory agencies, including the Department of Justice, the
Drug Enforcement Agency, the Food and Drug Administration and
the Federal Trade Commission, as well as the National
Association of Boards of Pharmacies, the National Association
of Drug Diversion Investigators and the National Association of
Attorneys General, representatives of the pharmaceutical
industry and the media.
To date, approximately 12 physicians have been the subject
of disciplinary action actions based on clearinghouse supplied
information. The clearinghouse has supplied information for
more than 127 cases at the Federal level and more than 200
cases on the State level. Additionally, information regarding
Internet prescribing has been shared with the Medical Counsel
of New Zealand and the Ministry of Health in Germany. The
Federation strongly supports State based regulation of the
practice of medicine.
With regard to Internet prescribing, however, State medical
boards have the authority to discipline licensed physicians
prescribing and dispensing medications inappropriately. Several
boards have already taken action against licensees, adopted
rules or policies or introduced legislation to clarify this
authority. In addition, State medical boards are communicating
among themselves regarding physicians licensed in more than one
State. These cooperative efforts have been effective in closing
several Internet sites and causing a number of physicians to
cease their affiliation with questionable operations.
That said, I also indicated in my testimony last March that
there were at least three issues that needed to be addressed
through Federal legislation in order to protect patients
ordering prescriptions over the Internet. I'm very pleased that
H.R. 3880, the Internet Pharmacy Consumer Protection Act,
addresses each of those issues.
First, I remarked that patients should know with whom they
are dealing. They should know the name and location of the
pharmacy that is dispensing the drug, and the name of the
physician who will be providing the medical consultation that
will be the basis of that prescription. I noted that almost
without exception, a State would find that such physician had
violated practice standards if he or she wrote a prescription
on the basis of an online questionnaire without having any pre-
existing relationship with the patient.
Therefore, disclosure will not only be beneficial to
patients but will allow State medical boards to identify
individuals against whom they can take disciplinary action.
H.R. 3880 specifically addresses the issue of disclosure by
amending the Food and Drug and Cosmetic Act with the addition
of a new section.
Second, I stated that State attorneys general were not able
to enjoin operations of an Internet pharmacy that affects
citizens in their particular States, if that pharmacy is
operated out of another State. Many of our member boards have
indicated that they believe that a number of Internet sites
that dispense drugs in an appropriate manner could be shut down
if the attorneys general had nationwide injunctive powers as
well as the ability to pursue other civil remedies, including
damages, restitution or other compensation across State lines.
Third, I noted that while State medical boards have the
authority to discipline physicians who are prescribing and
dispensing drugs over the Internet inappropriately and that
many boards had taken such action, State medical boards cannot
take action against operators of Internet sites that dispense
drugs. I also remarked that while State medical boards believe
that the law and regulations governing the physicians in their
State are clear as to what constitutes an appropriate
physician-patient relationship for purposes of writing a
prescription, some courts and prosecutors believed that certain
State laws and regulations were ambiguous in this regard. I
noted that because of that ambiguity, prosecutors had not
pursued certain legal actions.
Last, I offered to work with the committee in trying to
craft language that would define an appropriate physician-
patient relationship for purposes of regulating Internet
pharmacies, while preserving the rights and responsibilities of
State medical boards. The language in H.R. 3880, adding a new
section to the Food, Drug and Cosmetic Act, strikes a
reasonable balance in requiring for the narrow purpose of
regulating Internet pharmacies while regulating the exclusive
role of State medical boards and defining that relationship
under other circumstances.
In conclusion, H.R. 3880 satisfactorily addresses the
issues that were raised last year by the Federation of State
Medical Boards, and we believe that its enactment into law will
provide significant protection for consumers who use the
Internet to obtain pharmaceuticals.
I thank you for the opportunity to testify today, and I'll
be happy to answer any questions.
[The prepared statement of Dr. Thompson follows:]
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Chairman Tom Davis. Thank you very much.
Dr. Catizone.
Mr. Catizone. Thank you, Mr. Chairman and good morning
committee members. Thank you for the opportunity to be here
today.
The National Association of Boards of Pharmacy, which I
represent, its members are all the licensing jurisdictions in
the United States, Canada, Australia, New Zealand, and South
Africa. The VIPPS program is an integral component of the
services we provide to the States to help them regulate the
Internet and protect the public health.
Almost 1 year to the day, we appeared before this committee
to report on the activities of the Internet sites offering
prescription drugs for sale. Since that time, much has changed
and must has remained the same. Domestic, legitimate Internet
pharmacies continue to provide valuable and innovative services
to their patients.
Although not the focus of the proposed legislation, as
Chairman Davis indicated, illegal foreign importation
represents a significant threat to State regulation, and is an
issue that should be addressed. Rogue or illegal Internet sites
distributing prescription drugs without a prescription and
based in the United States, although a concern, can be
identified, and following appropriate due process, forced to
cease operations. The limiting factor for the States is our
resources and nationwide injunctive relief.
The required posting of information by Internet sites
outlined by H.R. 3880 is an important component of identifying
and eliminating rogue and illegal sites. However, NABP is
concerned that simply mandating the posting without any
credible verification of that information could mislead
consumers into believing that illegal or rogue sites are
operating legitimately. The required posting will also not
address foreign sites which pose the biggest problem for State
and Federal regulators.
Some of the examples given today by Mr. Hubbard and others
indicate the steps which these rogue or illegal operators will
take to confuse the public and hide information. The simple
posting of information without verification does not address
this critical issue.
NABP applauds the sponsors of H.R. 3880 for addressing the
patient-prescriber relationship and supports the language of
the bill. The proposed revisions, which identify and define a
qualifying medical relationship, will close a regulatory
loophole exploited by rogue and illegal Internet sites. Equally
as important, the proposed requirement of an in-person medical
evaluation will not adversely impact the practices of
telemedicine and telepharmacy.
NABP also strongly supports the provisions of H.R. 3880
which allow States to bring civil action forth to enjoin the
practices of illegal Internet sites and obtain nationwide
injunctions against their operations. NABP's experience
indicates that the operators of illegal and rogue sites are
extremely knowledgeable about State and Federal laws and will
locate their operations to those States or areas where their
activities are not specifically prohibited, and may in fact
fall within a regulatory grey area. Nationwide injunctive
relief will cease these practices and allow States to work
together to close regulatory loopholes and eliminate safe
havens within the United States for illegal and rogue sites.
NABP and the State Boards of Pharmacy believe that Internet
service providers, advertising services and search engines play
a direct role in abetting the activities of illegal and rogue
Internet sites. The inclusion of advertising on their sites
from the rogue and illegal pharmacies misinforms consumers that
such sites are legitimate and safe and have been qualified in
some way by the ISP, the search engine or the advertising
service. Such activity is a matter of concern for the States,
and at least one State is preparing a formal complaint against
such entities for aiding and abetting in a violation of State
and Federal laws.
NABP also requests that the legislation seek to curb the
actions of illegal and rogue sites using credit card companies.
NABP has been informed that information provided to the House
Committee on Energy and Commerce indicates that any purchase
made via Web site using a credit card would allow the credit
card company to locate the merchant bank and other detailed
information on the seller. More importantly, the information
presented to the Energy and Commerce Committee notes that the
credit card companies could quickly terminate relationships
with any vendors of such activities that are illegal.
NABP requests that the provisions of H.R. 3880 which hold
harmless interactive computer services or advertising services
be reconsidered, and these entities be required to assume
responsibility for their acceptance of funding and services
from illegal and rogue sites which threaten the public health
and safety.
Again, we appreciate the opportunity to share our comments
with the committee. We are hopeful that the proposed bill can
be revised to address the concerns of the State boards of
pharmacy, and we're anxious to work with the sponsors and
committee members in achieving this objective of ultimately
ensuring that consumers can safely use the Internet to obtain
prescription medications.
Thank you.
[The prepared statement of Mr. Catizone follows:]
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Chairman Tom Davis. Thank you very much.
General Kilgore, thanks for being with us.
Mr. Kilgore. Good morning. Thank you for inviting me and
thank you for the opportunity to testify today on behalf of
attorneys general around the Nation.
In the National Association of Attorneys General, I serve
as the Chair of the Prescription Drug Abuse Task Force. Many of
us have been in Washington this week to discuss important
issues facing our States. The issue of prescription drugs being
sold over the Internet certainly is one of them.
As we all know, the Internet offers tremendous
opportunities for e-commerce, but it's also a wireless trap for
fraud and scams, including the health risks involving the
online sales of prescription drugs. In July of last year, we
posted on our office Web site and issued a media alert warning
individuals of the perils of online prescription drugs,
including links for information on consumer safety for online
prescription purposes.
Thousands of Virginians rely on prescription drugs for
their health. Seniors and working families struggle to afford
prescription drugs. It is my role as attorney general to ensure
that consumers are protected from online fabricated pharmacies
whose main concern is the bottom line, not the health of the
purchaser. It is necessary to have the law enforcement tools to
shut down those rogue pharmacies, and that is why I am here
today.
Virginia prides itself on being a business friendly State.
As Attorneys General, we often look for creative ways for the
public and private sector to work together. There is a
legitimate purpose for online prescription sales, but only when
it is narrowly tailored to provide the convenience and cost
effective purchases following an actual visit with a physician
who then prescribes a patient medication that will improve the
patient's health. This legislation targets those companies who
use privacy concerns and convenience at the expense of the
health of the individual.
It is so easy to go to one of these sites and put in
information that doesn't accurately portray the health
condition, such as a higher weight to allow an individual to
purchase diet pills who really doesn't need those diet pills.
It is also easy for a child to make up their age to purchase
prescription drugs without their parents knowing. It is so easy
to go to one of these sites, get a prescription for a self-
prescribed condition, something an individual may have read off
another Internet site. No questionnaire can replace the
diagnosis of a physician who knows the patient and understands
their health history.
As attorneys general, we have worked together against rogue
pharmacies, but our current enforcement tools are lacking.
Right now, enforcement at the State level is limited to the
practice of prescribing and dispensing medication through State
laws and licensure agreement. Under this legislation, as
attorneys general, we need the additional enforcement authority
to take these individuals to court to shut down these illegal
Internet pharmacies.
It is vital that the Davis-Waxman Internet Pharmacy
Consumer Protection Act be adopted to protect our citizens,
because we believe the health care of our citizens is being
jeopardized. An individual who is savvy with technology can
easily startup one of these businesses and make it difficult
for law enforcement authorities to track them down. I want my
computer crimes unit to have the authority to go to Federal
court and shut down these illegitimate businesses and get
nationwide injunctions if necessary.
We need Congress to give us this authority, so that we can
continue to protect the health of our citizens. I urge you to
act favorably on this important health protection legislation
for the constituents of each member of this committee and
indeed, all Americans. Thank you so much for allowing me to be
with you today.
[The prepared statement of Mr. Kilgore follows:]
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Chairman Tom Davis. Mr. Kilgore, thank you very much for
being here.
Dr. Patchin.
Dr. Patchin. Good morning, Chairman Davis and members of
the committee.
My name is Rebecca Patchin, I'm a physician. I practice in
Riverside, CA. I'm an anesthesiologist and I practice full time
pain management in an outpatient setting.
In June 2003, I was elected to the AMA Board of Trustees
and we want to thank you for holding the hearing today on this
important policy issue. The safety of Internet prescribing and
pharmacies.
The AMA appreciates the opportunity to express our views on
Internet pharmacies, and the role of physicians in prescribing
and dispensing of medications through these pharmacies. The
Internet can be a valuable tool as a medical resource, and we
support the use of the Internet as a mechanism to prescribe and
dispense medications, as long as appropriate safeguards are in
place. These safeguards include ensuring high standards for
quality medical care.
I would like to raise three points regarding the regulation
of the Internet as a means of obtaining prescription
medications. The first is the patient-physician relationship,
the second is patient safety regarding the medications they
obtain, and the third is the balance of State, Federal and
private regulations. First, the AMA believes that Internet
pharmacy Web sites or physicians that sell or dispense
prescription medications without a prescription or without a
valid patient-physician relationship fall well below accepted
standards of high quality medical care. They are a threat to
the public health.
Any Internet communications between a patient and their
physician should supplement and enhance but not replace the
patient-physician relationship. The same must be true for
Internet transactions between a physician and the pharmacy on
behalf of the patient.
For physicians who prescribe via the Internet, a valid
patient-physician relationship requires the following.
Performing a physical examination of the patient, appropriate
to the nature and treatment of the problem that is presenting.
Taking a complete and reliable medical history and adequate
dialog, followup recordkeeping in order to inform the patients
and properly assess the outcome of the therapeutic
intervention.
Exceptions to the criteria that I stated above do exist.
Those would include covering for a partner on a night or
weekend for an existing patient, on call situations and
ordering refills for your existing patients. The bottom line is
that safeguards must be in place to make sure that patients
receive the appropriate medications based on their medical
history and physical exams.
Next, with respect to the medications obtained through the
Internet, patient safety is paramount. Protections need to be
in place to make sure that patients get the medications they
need from safe, reliable and identifiable sources, not from fly
by night sites that do not meet today's safety standards. The
AMA asks that physicians who practice medicine via the Internet
disclose identifying information on their Web site, including
the State or States in which they are licensed.
This type of disclosure requirement should also apply to
the Internet pharmacies. In addition, patients need a reliable
way to distinguish safe and legitimate sites from fraudulent
sites or sites operating below pharmacy standards. To address
this problem, the AMA will continue to work with organizations
such as the National Association of Boards of Pharmacy to make
legitimate sites more easily identifiable.
In addition, the AMA, in conjunction with the State medical
societies, will continue to urge our State medical boards to
investigate, and when appropriate, to take action against
physicians who fail to meet the accepted standards of medical
care with regard to Internet prescribing. We also expect that
States will continue to explore various methods of regulating
the manner and medium in which prescription drugs may be
prescribed.
Finally, on the Federal level there are currently several
bills, including the chairman's, that address many of the
problems we have cited here today in our written and oral
testimony. While the AMA has not yet taken a position on any
particular piece of legislation, we look forward to working
with the Members of Congress to develop appropriate legislative
solutions to counter the abusive Internet practices.
Together, we can protect our patients, prevent sub-standard
and illegal Internet prescribing and dispensing of medications,
and mostly, to ensure that the standards for high quality
medical care are fulfilled. Thank you for the opportunity to
express our views before this committee. I would be happy to
answer any questions.
[The prepared statement of Dr. Patchin follows:]
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Chairman Tom Davis. Thank you, Dr. Patchin.
Mr. Rector.
Mr. Rector. Good morning, Mr. Chairman and members of the
committee. I'm particularly pleased to be here to testify on
the Internet Pharmacy Consumer Protection Act, which is
directly focused on the domestic marketplace and the Internet
traffic in the United States.
The National Community Pharmacists Association was founded
in 1898. We represent the professional and proprietary
interests of the Nation's community pharmacists, including the
owners of 25,000 pharmacies. We are here to enthusiastically
endorse H.R. 3880 and commend the Chair and Ranking Member
Waxman for the work they have done on this measure.
We especially value the disclosure requirements, the
disclosure of the licensure of the pharmacist in the State or
States where he or she is licensed. We further strongly support
the focus on a bona fide relationship with the physician and
echo the testimony of several other witnesses this morning in
favor of the injunctive relief for the attorneys general to
reach the extra-territorial conduct of these Internet
businesses.
I wanted to make just a few additional comments. Whatever
is done regarding importation, we think you should focus
clearly and in great depth on the domestic marketplace.
Basically, Internet is just another form of mail order
pharmacy. Also we'd like to take a second to put in context our
point of view on these issues.
Only one State has enacted a statute requiring the extra-
territorial pharmacies to license a pharmacist in their State.
Just one State does that, Arkansas. So it's important to focus
on that. So disclosure is a step in the direction of informing
the consumer so he or she has the information to know whether
or not the pharmacist, if in fact they're dealing with a
pharmacist, is someone licensed in their own State. If they had
that information, it might help them make the appropriate
decision, along with the other criteria, as to whether or not
they should be doing business with that particular site.
In our attachment, we highlight a case brought by the U.S.
Justice Department versus one of the major domestic mail order
companies. We recommend a careful review by the committee
members and staff of the allegations there that have extensive
implications for the subject of this hearing and related
issues.
I note that Florida, California, Illinois, Tennessee,
Texas, Michigan, Louisiana, Nevada, Virginia, Massachusetts and
D.C. are parties to this whistleblower case that the Justice
Department has intervened in, which really highlights the weak
infrastructure currently in place regulating domestic mail
order.
I listened carefully to the comments of the National
Association of Boards of Pharmacy, and we caution the committee
not to take any steps in the bill that is eventually reported
that would have anti-competitive consequences with regards to
various private sector initiatives trying to ferret out the
rogue pharmacists and their allies.
And last, we'd like to draw attention also to those that
are facilitating these illegal transactions by unlicensed
physicians and pharmacies and pharmacists, whether it be the
credit card companies or those that facilitate the shipment to
the ultimate consumer in these illegal arrangements. We would
encourage the various Federal agencies to address these issues,
and frankly, we really don't think the FDA and HHS have
aggressively pursued the enforcement of existing statutes. The
Justice Department could take a close look at the mail order
fraud statutes, RICO and others in trying to address the
problem that you have so appropriately highlighted.
Thank you.
[The prepared statement of Mr. Rector follows:]
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Chairman Tom Davis. Thank you very much.
Dr. Thompson, I understand you need to leave at 12:00?
Dr. Thompson. I'll stay as long as you need me.
Chairman Tom Davis. We will not have an intervening vote,
so that's good. Let's start the questions, I'll start with you,
Dr. Thompson. H.R. 3880 gives State attorneys general Federal
injunctive relief against online pharmacies that are in
violation of the law. What impact do you think this injunctive
relief will have on shutting down the rogue Internet pharmacy
Web sites?
Dr. Thompson. The principal problem that we've encountered,
quite frankly, is the hesitancy of a number of attorneys
general and the inability of them to go after these rogue
sites. That's only superseded by the fact that it's very
difficult to locate where they are. Their location and change
of location is as simple as changing a Web page on a daily
basis.
But it would significantly increase an attorney general's
ability to close down pharmacies that are operating in not only
other States, but multiple States, and be able to go after
those rogue sites as well as allowing us to go after the
physicians that are involved in this practice.
Chairman Tom Davis. Mr. Kilgore, do you agree with that?
Mr. Kilgore. I do, Mr. Chairman. It's important that State
attorneys general have this ability. How I envision it would
work is that we would join together with other attorneys
general around the Nation when we identify one of these sites
to go in and shut it down.
Chairman Tom Davis. You still have a problem identifying
it, but at least now you would have a legal recourse, which you
really don't now.
Mr. Kilgore. That's right. It's much the way we have to do,
Mr. Chairman, with spammers under Virginia's anti-spam law,
under the new one passed by Congress. It's difficult to
identify these individuals because criminals find new ways
every day to go out and make money. But we can do it just, the
authority, the injunctive authority gives us greater abilities
to go into Federal courts and shut them down.
Chairman Tom Davis. What we continue to see is consumers
going to these Web sites, though. What's troubling is that
consumers are going to the Web sites because they think they're
getting cheaper drugs or whatever. And we today have heard a
lot of testimony on how bogus a lot of these drugs are. Aside
from the fact that even if they were correct, they may or may
not work and do what they were prescribed to do, because you
don't have the physician-patient relationship, many of these
drugs are actually bogus. We passed some around up here that
are routinely delivered over the Internet.
What do we do to better inform consumers of the problems in
this?
Mr. Catizone. Mr. Chairman, I think that's a major dilemma,
because we're sending mixed messages to consumers. On one hand
we're telling them it's OK to import medications from Canada,
and we don't know if those sources are truly Canada, and on the
other hand, we're saying they're very dangerous, and we have
examples of those dangers, counterfeit drugs. We've received
over 100 consumer complaints about medications ordered over the
Internet, at least $20,000 worth of consumer fraud where they
ordered medications and didn't receive those medications, and a
number of complaints that the products were counterfeit or
didn't have any active ingredient whatsoever.
So that's a significant challenge for us, sending one
message to the consumer about using the distribution system
that's approved and safeguarded by the FDA and State agencies.
Chairman Tom Davis. I guess if anybody, if they would
counterfeit a prescription, with a physician writing a
prescription, without it, they'd certainly counterfeit the
drug, I don't know why there would be any difference on that.
Does anybody else have any observations on that?
Mr. Kilgore. Mr. Chairman, I would say that traveling
around Virginia and speaking with senior organizations, I've
picked up on the mixed messages that they are getting as well.
That's why we felt it was important to weave into every
presentation to senior organizations around Virginia the fact
that you must be sure who you are dealing with when you are
ordering prescriptions online or, and reminding our seniors
that Virginia law does not allow the importation, and further
making it clear that you need to retain that doctor-patient
relationship, so that they know exactly how each drug interacts
with other drugs.
Chairman Tom Davis. Dr. Patchin, let me ask you, you didn't
specifically endorse any piece of legislation. I know your
organization is careful not to do that. But do you think the
provisions that we have in this legislation that Mr. Waxman and
I have drafted, defining an appropriate medical relationship is
consistent with AMA guidelines regarding prescribing
medications?
Dr. Patchin. Yes, they appear consistent. And on your last
question, I might add, I practice in a border State, and a
State where the importation is not Canada, and where many of
our imported medications come in. I view it as patient
education, something that I work with one on one with my
patients about the safety of the medications that they may get
from other areas by driving a few hundred miles. Again, they
need to look at safety and whether the medication is really
what they're getting.
Chairman Tom Davis. My time is up, but real quick, does the
AMA think it's important for Internet pharmacy sites to
disclose physician identifying information, like their
licensure information on their Web sites?
Dr. Patchin. Yes. In my testimony, I stated that the
physician and the pharmacy should have identifying information,
so that the patient could contact the pharmacy as well as the
physician.
Chairman Tom Davis. Thank you very much. Mr. Waxman.
Mr. Waxman. Thank you very much, Mr. Chairman.
Mr. Kilgore, you testified about the importance of the
provision in this bill that would give State attorneys general
the ability to shut down illegitimate Internet pharmacies
nationwide. Would having the power to obtain nationwide
injunctions encourage more enforcement by State attorneys
general against these Web sites, and would this power be
consistent with traditional State authority over the practice
of medicine and pharmacy?
Mr. Kilgore. It absolutely would encourage us to take
action. The reluctance at this point, we can take action under
State laws sometimes, but we cannot find these individuals. We
need this ability so that we can join with other attorneys
general and shut these down.
Mr. Waxman. So what we do is provide a nationwide
opportunity to deal with this problem but not take away the
prerogative of the States as they've traditionally dealt with
some of these issues?
Mr. Kilgore. That's correct. We appreciate that.
Mr. Waxman. Thank you. Mr. Catizone, you testified in
strong support of the two key provisions of the bill. You
endorsed the establishment of Federal standards for what is a
valid prescription related to Internet prescribing. You also
supported giving State attorneys general the authority to shut
down these sites nationwide.
I'd like to ask you about two areas where you've made some
suggestions for improvement in the legislation. First, you've
expressed concern about how the legislation deals with Internet
service providers and search engines that might sell
advertisements to illegitimate pharmacies. Are you aware of
efforts by Yahoo, Google and other Internet companies to refuse
to sell advertisements by some of these Internet pharmacies?
Mr. Catizone. Yes, I am, sir. We spoke to those search
engines and they've indicated they are interested in doing so.
We're not convinced that their efforts go far enough. They seem
to be accepting accreditation or approval processes that don't
involve a very serious inspection of those sites or very
serious review of what they're doing. In fact, they probably
will be accepting advertisements from Canadian pharmacies which
are operating illegally.
Mr. Waxman. What makes this a difficult issue is that the
intent of the legislation is to focus on those responsible for
the illegitimate Web sites, not those who make the sites
available to the public. I want to look over your suggestion, I
think it's one we need to carefully consider, and I appreciate
that thought behind it.
You've also made the suggestion that Internet pharmacies
should participate in a formal disclosure and verification
program such as the VIPPS program, which is run by the National
Association of Boards of Pharmacy. You suggested that one
benefit of such an approach might be better enforcement.
Are you suggesting that participating in VIPPS or in an
equivalent program be required of all Internet pharmacies?
Mr. Catizone. Mr. Waxman, we've talked about this issue
with a variety of groups and yes, we're recommending some
mandatory program. The voluntary program isn't going far
enough, and those sites will do anything they can to confuse
consumers and to hide information. So simply requiring the
posting of information that will probably be fraudulent in many
cases won't help the consumers.
Mr. Waxman. How many participating Internet pharmacies does
VIPPS certify now?
Mr. Catizone. We currently have 13 sites representing 8,000
to 10,000 pharmacies in the United States.
Mr. Waxman. And if all the Internet pharmacies were
required to participate in VIPPS, how many do you think might
apply?
Mr. Catizone. They estimate that the Internet pharmacy
market is anywhere between 8 percent and 22 percent of existing
pharmacies. There are probably right now 75,000 pharmacies
licensed in the United States. So that number would be 8
percent to 10 percent of that, upward to 7,500 pharmacies.
Mr. Waxman. I appreciate the advantages of the VIPPS
program. It's a model we believe the Secretary should look at
when considering how to implement this bill. However,
regulating a few large Internet pharmacies is not the same as
monitoring what could be hundreds of thousands of Internet
pharmacies. This is an enforcement challenge for anyone,
whether VIPPS or FDA or the State attorneys general. We'll
review this situation carefully. I think it's one that I'm
pleased you brought to our attention.
Dr. Patchin, your testimony covered a wide variety of
topics, but I want to ask you about a couple of specifics. You
testified that current AMA policy requires physicians to
prescribe via the Internet to clearly disclose physician
identifying information on the Web site. Are you aware that
H.R. 3880 includes this requirement as well as the requirement
that pharmacies also be identified, and would you agree that
the disclosure provisions in this bill are consistent with AMA
policy?
Dr. Patchin. At this time, yes.
Mr. Waxman. OK, good. And you testified that AMA policy
prohibits prescribing medications without a valid doctor-
patient relationship. This includes performing a physical
examination adequate to establish the diagnosis, having
sufficient dialog with the patient regarding risks and
maintaining a medial record that's readily available to the
patient.
In your judgment, is a doctor who churns out prescription
after prescription on the basis of little or no information
through an arrangement with an Internet pharmacy in compliance
with AMA policy? And are you aware that this bill prohibits
Internet pharmacies from arranging for doctors to write
prescriptions to consumers without ever seeing them?
Dr. Patchin. The physician who writes a prescription
without the patient-physician relationship as we described
would be in violation of AMA policy, correct.
Mr. Waxman. Do you think this is a good provision for
accomplishing that goal?
Dr. Patchin. Yes.
Mr. Waxman. Thank you very much.
Thank you, Mr. Chairman.
Chairman Tom Davis. Thank you very much. Mr. Carter, any
questions?
Mr. Carter. Thank you, Mr. Chairman.
When we're dealing with lawsuits in the United States, the
plaintiff's bar will argue that a lot of what they do as taking
actions in the plaintiff's bar is policing up organizations
that don't police themselves and targeted, as AMA. But the
doctors don't police up their malpractice.
Now, what I've heard testimony here today is that you would
sanction, I would like to know exactly, if you were to identify
a doctor who is operating this illegal procedure, what sanction
would you take with that doctor? Would you punch his ticket and
stop him from practicing medicine?
Dr. Thompson. Yes, sir. The Federation of State medical
boards is the membership association of the Nation's 70
licensing and territorial regulatory authorities. A number of
licenses have been revoked and there have been disciplinary
actions taken against a number of physicians that have been
involved in this kind of activity. It can be anything from a
slap on the hand to a license revocation. But the kind of
activity that we've seen more often than not leads to
revocation of a license.
Difficult, however to track these physicians down and very
difficult to work across State lines in this kind of activity.
Mr. Carter. I understand that we're giving tools to the
attorneys general across the States to try to help do this. But
part of the ultimate solution has to be, those people who are
violating standards, violating laws and threatening lives have
to be taken out of the system. If they're not taken out of the
system, they're going to figure out another crooked way to do
this thing.
Dr. Thompson. The most notorious of the individuals who
deals with Internet prescriptions had a license in 26 different
States, and to date has had 14 of those removed and by
reciprocal action through the information services that we
provide through the Federation is soon on his way to having all
of his licenses revoked.
Mr. Carter. And the same question I would direct to the
people involved in pharmacy. Would the pharmacies also punch
the ticket on people who are doing this what I consider illegal
operation?
Dr. Thompson. Yes, sir.
Mr. Carter. That's all the questions I have, Mr. Chairman.
Thank you.
Chairman Tom Davis. Thank you very much. Mr. Towns.
Mr. Towns. Thank you very much, Mr. Chairman.
Let me begin with you, Dr. Patchin. You used the term
``safeguards must be in place'' on two occasions. What do you
mean by safeguards must be in place?
Dr. Patchin. Safeguards regarding the Internet prescribing
would be to those that ensure that there is an approved supply
of drugs that are the right dose, the right drug for the right
patient, with the right, appropriate dosing interval and the
right time. The safeguards for prescribing would also include
State laws that govern the practice of medicine as well as the
prescribing in the community standard.
Mr. Towns. Thank you. My concern, and I guess this is to
the Attorney General, this legislation is dealing with domestic
Web sites, it doesn't do anything with international Web sites.
And I'm sort of concerned about the fact that once the noose is
tightened that we might have a problem in terms of people going
out of the country and doing almost the same thing. So what do
we do here?
I'm concerned, I'm in favor of shutting down all Internet
pharmacy sites. However, it appears that better oversight and
controls are needed, but purchasing drugs through the Internet
can offer incredible, no question about it, benefits for
homebound patients. And of course, patients that might have a
disease of some sort that might not want the world to know,
there's benefits there as well.
But I am concerned, so I'd like to hear your comments
about, once we tighten the noose, what we might run into.
Mr. Kilgore. That very well could happen. This is a great
first step to control the domestic Internet companies. It's a
great first step to give State attorneys general the ability to
enforce the act. We recognize that as we go about enforcing the
act that, as we shut down Internet pharmacies that we could see
the effect you are talking about, i.e., the move overseas, they
go international, then we will have to address that through our
relationship with the FDA and work with the FDA and DEA on
those important issues.
Mr. Towns. Thank you. I guess this is for the doctors on
the panel. In your experience, do health care professionals
typically inquire about where a patient obtains his or her
prescription drug before making changes or switching to an
alternative product? Is that question generally asked, where
you get your medication from?
Dr. Patchin. Yes. Part of the assessment in obtaining the
history and physical would be questions to find out what
medications they are taking and who is prescribing them. You
will find out where they're filling them. Many times I find out
even the name of the pharmacy or the provider that they're
getting their medications dispensed from.
Dr. Thompson. Dr. Patchin is an anesthesiologist who deals
in pain management, so she's more likely dealing with the type
of drugs that we're talking about. I'm an ear, nose and throat
doctor, and I infrequently deal with heavy narcotics and so in
my practice, I would not necessarily have known where someone
filled their prescription. I would, however, know what drugs
they have been taking and for what reason they have been taking
them.
Mr. Towns. Mr. Catizone, I want to hear from you on this.
Mr. Catizone. That's a very critical question. We're trying
to work with the physician groups to ask patients that
question. Because if their blood pressure is uncontrollable or
their diabetes worsens, the assumption made is that the
medication is not working, so they increase the dose or change
the medication, when it could be a counterfeit product or a
product that has no active ingredients.
So we would also ask that be a consideration of any of
these discussions. We're going to ask the FDA to change their
Med Watch form to allow for that information to be asked, so
they can identify whether it came from outside the U.S.
distribution system.
Mr. Towns. Let me say, Mr. Chairman, I think this
legislation is good. But the question in my mind is, does it go
far enough. I would like to have an extra second or two just to
run down the line and ask each member in terms of what they
might want to add to make it better.
Chairman Tom Davis. Sure.
Dr. Thompson. First of all, let me say that for the
purposes of addressing the problem that this committee has been
confronted with, this legislation is excellent. I would applaud
the Chair and the other leaders of this committee for I think
superb legislation that will deal with the issue.
Chairman Tom Davis. Take as much time as you need.
[Laughter.]
Dr. Thompson. There are a number of other issues, however,
that relate to the technology, and we in this Nation have seen
a situation in which the technology has far superseded our
ability to deal with the ethics or the regulation of that
technology. And quite frankly, we're playing catchup. This is a
giant leap forward, I believe, for the citizens in this
country. There remains much work to be done, however.
Mr. Catizone. I would echo Dr. Thompson's compliments on
the bill. Absent the fact that we believe the disclosure should
be mandatory, should be verified, in regard to the patient and
the question of where the medication should be obtained from,
that may not be a matter for legislation. That's a matter for
the Federation and the American Medical Association to work
together and increase that as a standard of care for patients
as part of the diagnosis differential.
Mr. Kilgore. I totally support this legislation. It's a
great move forward, and a great move to protect patients'
rights in the future, and it gives certainly attorneys general
around the Nation the ability to protect our consumers. The one
issue I think we must deal with in the future is the important
issues, so that we avoid sending mixed messages to our seniors
and others in our State about whether they should be able to
import drugs from foreign countries. We need to, if we allow
that we need to make sure those drugs are safe, those drugs are
accurate, and we continue to require a physician-patient
relationship.
Dr. Patchin. I would like to make a plea for the patient's
safety. The patient's safety is ensuring that they're getting
the right drug, in the right concentration, in the right
vehicle and the right timing as part of the patient-physician
relationship in that prescribing.
Mr. Rector. We strongly endorse the legislation in each of
its key provisions. We think it's carefully drawn to avoid any
anti-competitive consequences by endorsing one private sector
certification program over another. But a related subject, not
necessarily for this committee, but perhaps, would be to
carefully review the statutes that are available to prosecute
those entities that are facilitating the illegal commerce, both
foreign and domestic. That means the shippers and the credit
card companies and others. If the subject was stolen property,
there would be no question. This is a lot more serious,
typically, than stolen property.
Mr. Towns. Thank you very much. Mr. Chairman, I don't have
anything to yield back, so I'll just stop. [Laughter.]
Chairman Tom Davis. Thank you very much, Mr. Towns. I just
want to ask a couple of followup questions.
Mr. Rector, you stated in your testimony that the
regulation of the practice of pharmacy by pharmacists rests
exclusively with the respective States. I just want you to
reiterate again for the record the need for H.R. 3880 as a
Federal law when you already have the State regulation from
your perspective as a pharmacist.
Mr. Rector. We think that H.R. 3880 ideally complements the
jurisdiction that the States enjoy, both over the practice of
medicine and the practice of pharmacy.
Chairman Tom Davis. And the world has basically changed
with the Internet, isn't that what's happened here, and
everybody agrees, that the old rules don't apply when you have
such a ubiquitous communications device as the Internet?
Mr. Rector. Absolutely.
Chairman Tom Davis. And certainly, Mr. Kilgore, from an
enforcement point of view it changes everything. You noted it's
hard to find these people, and in many cases, you really want
to join with other attorneys general to shut them down, because
you're chasing them all over the globe?
Mr. Kilgore. That's true. The Internet has become the wild
west, if you will, and we need this added ability in our
enforcement tools to go after these rogue pharmacies.
Chairman Tom Davis. Let me ask you, with your experience on
spammers, I know you brought one of the first cases in the
country prosecuting spamming and so on, how is that going? You
used one of your strongest State laws, I know, which you and
Senator Stiley and Senator Devolites helped write. How has that
helped and what does your experience on that tell you about
this?
Mr. Kilgore. Again, it confirms our fear in the State that
these cases take a lot of time, a lot of energy in our office
to investigate and track down these individuals that are
committing crimes. We have charts and charts that fill up a
room where we've traced the ISPs from, gone to the ISP to get
their address only to find out they're operating in many
different domains. It just takes a lot of time and computer
crunching. But we continue to investigate, just like we will
once we are given this authority under this legislation to
investigate and shut down these pharmacies.
Chairman Tom Davis. As I understand it, today, if someone
is selling Lipitor and it's not Lipitor, or they're selling
Viagra and it's not Viagra, you can prosecute them for that if
you can run them down, is that right?
Mr. Kilgore. That is correct.
Chairman Tom Davis. But this gives you the additional tool,
because they're doing it without a prescription, and that's
probably even easier to prove, is that probably----
Mr. Kilgore. Much easier.
Chairman Tom Davis. Everybody understands this is just an
additional tool to try and get some of these folks. In addition
to that, without the appropriate medical authorization, people
are at risk. The new disclosure standards ought to help
identify the offending Web site, shouldn't it? We talked about
pharmacies and doctors, talked about where you get it, wouldn't
that help disclose the offending Web sites as well?
Mr. Kilgore. I would think it would.
Mr. Catizone. We think it's a first step. We think it's not
going to address the issue entirely, though.
Chairman Tom Davis. OK. Well, thank you very much. This has
been very helpful to us. We'd like to do something about that,
and having the support and the testimony from your
organizations is very critical in this. Again, I want to thank
all the witnesses for taking their time to testify today. And
the hearing is closed.
Thank you.
[Whereupon, at 12:01 p.m., the committee was adjourned, to
reconvene at the call of the Chair.]
[The prepared statement of Hon. Carolyn B. Maloney and
additional information submitted for the hearing record
follow:]
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