[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 788 Introduced in House (IH)]
110th CONGRESS
1st Session
H. R. 788
To amend the Federal Food, Drug, and Cosmetic Act with respect to drug
safety, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 31, 2007
Mr. Tierney (for himself and Mr. Ramstad) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to drug
safety, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food and Drug Administration Safety
Act of 2007''.
SEC. 2. CENTER FOR POSTMARKET EVALUATION AND RESEARCH FOR DRUGS AND
BIOLOGICS.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506C
the following:
``SEC. 507. DRUG SAFETY.
``(a) Establishment of the Center for Postmarket Evaluation and
Research for Drugs and Biologics.--There is established within the Food
and Drug Administration a Center for Postmarket Evaluation and Research
for Drugs and Biologics (referred to in the section as the `Center').
The Director of the Center shall report directly to the Commissioner of
Food and Drugs.
``(b) Duties of the Center for Postmarket Evaluation and Research
for Drugs and Biologics.--
``(1) Responsibilities of director.--The Director of the
Center in consultation with the Director of the Center for Drug
Evaluation and Research or the Director of the Center for
Biologics Evaluation and Research, as appropriate, shall--
``(A) conduct postmarket risk assessment of drugs
approved under section 505 of this Act and of
biological products licensed under section 351 of the
Public Health Service Act;
``(B) conduct and improve postmarket surveillance
of approved drugs and licensed biological products
using postmarket surveillance programs and activities
(including Midwatch), risk-benefit analyses, adverse
event reports, the scientific literature, any clinical
or observational studies (including studies required
under subsection (d) or (e)), and any other resources
that the Director of the Center determines appropriate;
``(C) determine whether a study is required under
subsection (d) or (e) and consult with the sponsors of
drugs and biological products to ensure that such
studies are completed by the date, and according to the
terms, specified by the Director of the Center;
``(D) contract, or require the sponsor of an
application or the holder of an approved application or
license to contract, with the holders of domestic and
international patient databases to conduct
epidemiologic and other observational studies;
``(E) determine, based on postmarket surveillance
programs and activities (including Midwatch), risk-
benefit analyses, adverse event reports, the scientific
literature, and any clinical or observational studies
(including studies required under subsection (d) or
(e)), and any other resources that the Director of the
Center determines appropriate, whether a drug or
biological product may present an unreasonable risk to
the health of patients or the general public, and take
corrective action if such an unreasonable risk may
exist;
``(F) make information about the safety and
effectiveness of approved drugs and licensed biological
products available to the public and healthcare
providers in a timely manner; and
``(G) conduct other activities as the Director of
the Center determines appropriate to ensure the safety
and effectiveness of all drugs approved under section
505 and all biological products licensed under section
351 of the Public Health Service Act.
``(2) Determination of unreasonable risk.--In determining
whether a drug or biological product may present an
unreasonable risk to the health of patients or the general
public, the Director of the Center in consultation with the
Director of the Center for Drug Evaluation and Research or the
Director of the Center for Biologic Evaluation and Research, as
appropriate, shall consider the risk in relation to the known
benefits of such drug or biological product.
``(c) Secretarial Authority.--
``(1) In general.--Approval of a drug under section 505 of
this Act or issuance of a license for a biological product
under section 351 of the Public Health Service Act may be
subject to the requirement that the sponsor conduct 1 or more
postmarket studies as described in subsection (d) or (e) of
this section, or other postmarket studies as required by the
Secretary, to validate the safety and effectiveness of the drug
or biological product.
``(2) Definition.--For purposes of this section, the term
`postmarket' means--
``(A) with respect to a drug, after approval of an
application under section 505; and
``(B) with respect to a biological product, after
licensor under section 351 of the Public Health Service
Act.
``(d) Preapproval Review.--
``(1) Review of application.--
``(A) In general.--
``(I) Review.--At any time before a drug is
approved under section 505 of this Act or a
biological product is licensed under section
351 of the Public Health Service Act, the
Director of the Center shall review the
application (or supplement to the application),
and any analyses associated with the
application, of such drug or biological
product.
``(ii) Effect of approval or licensor.--The
approval of a drug under section 505 or the
licensor of a biological product under such
section 351 shall not affect the continuation
and completion of a review under clause (I).
``(B) Limitation.--In no case shall the review
under subparagraph (A) delay a decision with respect to
an application for a drug under section 505 of this Act
or for a biological product under section 351 of the
Public Health Service Act.
``(2) Result of review.--The Director of the Center may,
based on the review under paragraph (1)--
``(A) require that the sponsor of the application
agree to conduct 1 or more postmarket studies to
determine the safety or effectiveness of a drug or
biological product, including such safety or
effectiveness as compared to other drugs or biological
products, to be completed by a date, and according to
the terms, specified by the Director of the Center; or
``(B) contract, or require the sponsor of the
application to contract, with a holder of a domestic or
an international patient database to conduct 1 or more
epidemiologic or other observational studies.
``(e) Postmarketing Studies of Drug Safety.--
``(1) In general.--At any time after a drug is approved
under section 505 of this Act or a biological product is
licensed under section 351 of the Public Health Service Act,
the Director of the Center, may--
``(A) require that the holder of an approved
application or license conduct 1 or more studies to
determine the safety or effectiveness of such drug or
biological product, including such safety and
effectiveness as compared to other drugs or biological
products, to be completed by a date, and according to
the terms, specified by such Director; or
``(B) contract, or require the holder of the
approved application or license to contract, with a
holder of a domestic or an international patient
database to conduct 1 or more epidemiologic or other
observational studies.
``(2) Review of outstanding studies.--Not later than 90
days after the date of enactment of the Food and Drug
Administration Safety Act of 2007, the Director of the Center
shall--
``(A) review and publish a list in the Federal
Register of any postmarketing studies outstanding on
the date of enactment of the Food and Drug
Administration Safety Act of 2007; and
``(B) as the Director determines appropriate,
require the sponsor of a study described in
subparagraph (A) to conduct such study under this
subsection.
``(f) Publication of Progress Reports and Completed Studies.--
``(1) In general.--The Director of the Center shall require
that the sponsor of a study under subsection (d) or (e) submit
to the Secretary--
``(A) not less frequently than every 90 days, an
up-to-date report describing the progress of such
study; and
``(B) upon the completion date of such study, the
results of such study.
``(2) Completion date.--For purposes of this section, the
completion date of such study shall be determined by the
Director of the Center.
``(g) Determinations by Director.--
``(1) Results of study.--The Director of the Center shall
determine, upon receipt of the results of a study required
under subsection (d) or (e)--
``(A) whether the drug or biological product
studied may present an unreasonable risk to the health
of patients or the general public; and
``(B) what, if any, corrective action under
subsection (k) shall be taken to protect patients and
the public health.
``(2) Results of evidence.--The Director of the Center may,
at any time, based on the empirical evidence from postmarket
surveillance programs and activities (including MedWatch),
risk-benefit analyses, adverse event reports, the scientific
literature, any clinical or observational studies (including
studies required under subsection (d) or (e)), or any other
resources that the Director of the Center determines
appropriate--
``(A) make a determination that a drug or
biological product may present an unreasonable risk to
the health of patients or the general public; and
``(B) order a corrective action under subsection
(k) be taken to protect patients and the public health.
``(3) Required consultation and considerations.--Before
making a determination under paragraph (2), ordering a study
under subsection (d) or (e), or taking a corrective action
under subsection (k), the Director of the Center shall--
``(A) consult with the Director of the Center for
Drug Evaluation and Research or the Director of the
Center for Biologics Evaluation and Research, as
appropriate; and
``(B) consider--
``(i) the benefit-to-risk profile of the
drug or biological product;
``(ii) the effect that a corrective action,
or failure to take corrective action, will have
on the patient population that relies on the
drug or biological product; and
``(iii) the extent to which the drug or
biological product presents a meaningful
therapeutic benefit as compared to other
available treatments.
``(h) Public Information.--Periodically, but not less often than
every 90 days, the Secretary shall make available to the public, by
publication in the Federal Register and posting on an Internet website,
the following information:
``(1) Studies required under subsection (d) or (e)
including--
``(A) the type of study;
``(B) the nature of the study;
``(C) the primary and secondary outcomes of the
study;
``(D) the date the study was required under
subsection (d) or (e) or was agreed to by the sponsor;
``(E) the deadline for completion of the study; and
``(F) if the study has not been completed by the
deadline under subparagraph (E), a statement that
explains why.
``(2) The periodic progress reports and results of
completed studies described under subsection (f).
``(3) Any determinations made by the Director of the Center
under subsection (g), including--
``(A) reasons for the determination, including
factual basis for such determination;
``(B) reference to supporting empirical data; and
``(C) an explanation that describes why contrary
data is insufficient.
``(i) Drug Advisory Committee.--The Drug Safety and Risk Management
Drugs Advisory Committee within the Center of the Food and Drug
Administration shall--
``(1) meet not less frequently than every 180 days; and
``(2) make recommendations to the Director of the Center
with respect to--
``(A) which drugs and biological products should be
the subject of a study under subsection (d) or (e);
``(B) the design and duration for studies under
subsection (d) or (e);
``(C) which drugs and biological products may
present an unreasonable risk to the health of patients
or the general public; and
``(D) appropriate corrective actions under
subsection (k).
``(j) Penalties.--
``(1) In general.--If the Secretary determines, after
notice and opportunity for an informal hearing, that a sponsor
of a drug or biological product or other entity has failed to
complete a study required under subsection (d) or (e) by the
date or to the terms specified by the Secretary under such
subsection, the Secretary may order such sponsor or other
entity to--
``(A) complete the study in a specified time;
``(B) revise the study to comply with the terms
specified by the Secretary under subsection (d) or (e);
or
``(C) pay a civil penalty.
``(2) Amount of penalties.--
``(A) In general.--The civil penalty ordered under
paragraph (1) shall be $250,000 for the first 30-day
period after the date specified by the Secretary that
the study is not completed, and shall double in amount
for every 30-day period thereafter that the study is
not completed.
``(B) Limitation.--In no case shall a penalty under
subparagraph (A) exceed $2,000,000 for any 30-day
period.
``(3) Notification of penalty.--The Secretary shall publish
in the Federal Register any civil penalty ordered under this
subsection.
``(k) Result of Determination.--
``(1) In general.--If the Director of the Center makes a
determination that a drug or biological product may present an
unreasonable risk to the health of patients or the general
public under subsection (g), such Director shall order a
corrective action, as described under paragraph (2).
``(2) Corrective actions.--The corrective action described
under subsection (g)--
``(A) may include--
``(i) requiring a change to the drug or
biological product label by a date specified by
the Director of the Center;
``(ii) modifying the approved indication of
the drug or biological product to restrict use
to certain patients;
``(iii) placing restriction on the
distribution of the drug or biological product
to ensure safe use;
``(iv) requiring the sponsor of the drug or
biological product or license to establish a
patient registry;
``(v) requiring patients to sign a consent
form prior to receiving a prescription of the
drug or biological product;
``(vi) requiring the sponsor to monitor
sales and usage of the drug or biological
product to detect unsafe use;
``(vii) requiring patient or physician
education; and
``(viii) requiring the establishment of a
risk management plan by the sponsor; and
``(B) shall include the requirements with respect
to promotional material under subsection (l)(1).
``(3) Penalties.--
``(A) In general.--If the Secretary determines,
after notice and opportunity for an informal hearing,
that a sponsor of a drug or biological product has
failed to take the corrective action ordered by the
Director of the Center under this subsection or has
failed to comply with subsection (l)(2), the Secretary
may order such sponsor to pay a civil penalty.
``(B) Amount of penalties.--
``(i) In general.--The civil penalty
ordered under subparagraph (A) shall be
$250,000 for the first 30-day period that the
sponsor does not comply with the order under
paragraph (1), and shall double in amount for
every 30-day period thereafter that the order
is not complied with.
``(ii) Limitation.--In no case shall a
penalty under clause (i) exceed $2,000,000 for
any 30-day period.
``(C) Notification of penalty.--The Secretary shall
publish in the Federal Register any civil penalty
ordered under this paragraph.
``(l) Promotion Material.--
``(1) Safety issue.--If the Director of the Center makes a
determination that a drug or biological product may present an
unreasonable risk to the health of patients or the general
public under subsection (g), such Director, in consultation
with the Division of Drug Marketing, Advertising, and
Communications of the Food and Drug Administration, shall--
``(A) notwithstanding section 502(n), require that
the sponsor of such drug or biological product submit
to the Director of the Center copies of all promotional
material with respect to the drug or biological product
not less than 30 days prior to the dissemination of
such material; and
``(B) require that all promotional material with
respect to the drug or biological product include
certain disclosures, which shall be displayed
prominently and in a manner easily understood by the
general public, including--
``(i) a statement that describes the
unreasonable risk to the health of patients or
the general public as determined by the
Director of the Center;
``(ii) a statement that encourages patients
to discuss potential risks and benefits with
their healthcare provider;
``(iii) a description of the corrective
actions required under subsection (k);
``(iv) where appropriate, a statement
explaining that there may be products available
to treat the same disease or condition that
present a more favorable benefit-to-risk
profile, and that patients should talk to their
healthcare provider about the risks and
benefits of alternative treatments;
``(v) a description of any requirements of
outstanding clinical and observational studies,
including the purpose of each study; and
``(vi) contact information to report a
suspected adverse reaction.
``(2) New products; outstanding studies.--For the first 2-
year period after a drug is approved under section 505 of this
Act or a biological product is licensed under section 351 of
the Public Health Service Act, and with respect to drugs and
biological products for which there are outstanding study
requirements under subsection (d) or (e), the Director of the
Center, in consultation with the Division of Drug Marketing,
Advertising, and Communications of the Food and Drug
Administration, shall--
``(A) notwithstanding section 502(n), require that
the sponsor of such drug or biological product submit
to the Director of the Center copies of all promotional
material with respect to the drug or biological product
not less than 30 days prior to the dissemination of
such material; and
``(B) require that all promotional material with
respect to the drug or biological product include
certain disclosures, which shall be displayed
prominently and in a manner easily understood by the
general public, including--
``(i) a statement explaining that the drug
or biological product is newly approved or
licensed or the subject of outstanding clinical
or observational studies, as the case may be,
and, as a result, not all side effects or drug
interactions may be known;
``(ii) the number of people in which the
drug or biological product has been studied and
the duration of time during which the drug or
biological product has been studied;
``(iii) a statement that encourages
patients to discuss the potential risks and
benefits of treatment with their healthcare
provider;
``(iv) a description of any requirements of
outstanding clinical and observational studies,
including the purpose of each study; and
``(v) contact information to report a
suspected adverse reaction.
``(3) Effect of voluntary submission.--Paragraphs (1)(A)
and (2)(A) shall not apply to the sponsor of a drug or
biological product if such sponsor has voluntarily submitted to
the Division of Drug Marketing, Advertising, and Communications
of the Food and Drug Administration all promotional material
with respect to the drug or biological product prior to the
dissemination of such material.
``(m) Withdrawal or Suspension of Approval or Licensure.--
``(1) In general.--The Director of the Center, may withdraw
or suspend approval of a drug or licensure of a biological
product using expedited procedures (as prescribed by the
Secretary in regulations promulgated not later than 1 year
after the date of enactment of the Food and Drug Administration
Safety Act of 2007, which shall include an opportunity for an
informal hearing) after consultation with the Director of the
Center for Drug Evaluation and Research or the Director of the
Center for Biologics Evaluation and Research, as appropriate,
and any other person as determined appropriate by the Director
of the Center, if--
``(A) the Director of the Center makes a
determination that the drug or biological product may
present an unreasonable risk to the health of patients
or the general public, and that risk cannot be
satisfactorily alleviated by a corrective action under
subsection (k); or
``(B) the sponsor fails to comply with an order or
requirement under this section.
``(2) Public information.--The Secretary shall make
available to the public, by publication in the Federal Register
and posting on an Internet website, the details of the
consultation described in paragraph (1), including--
``(A) the reason for the determination to withdraw,
suspend, or failure to withdraw or suspend, approval
for the drug or licensure for the biological product;
``(B) the factual basis for such determination;
``(C) reference to supporting empirical data;
``(D) an explanation that describes why contrary
data is insufficient; and
``(E) the position taken by each individual
consulted.
``(n) Effect of Section.--The authorities conferred by this section
shall be separate from and in addition to the authorities conferred by
section 505B.
``(o) Administration of Section.--The provisions of this section
shall be carried out by the Secretary, acting through the Director of
the Center.''.
(b) Misbranding.--Section 502 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352) is amended by inserting after subsection
(j) the following:
``(k) If it is a drug or biological product for which the sponsor
of an application or holder of an approved application or license has
not complied with an order or requirement under section 507.''.
(c) Report on Devices.--Not later than 6 months after the date of
enactment of this Act, the Secretary of Health and Human Services, in
consultation with the Commissioner of Food and Drugs, the Director of
the Center for Postmarket Evaluation and Research for Drugs and
Biologics, and the Director of the Center for Devices and Radiological
Health, shall submit to Congress a report that--
(1) identifies gaps in the current process of postmarket
surveillance of devices approved under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321 et seq.);
(2) includes recommendations on ways to improve gaps in
postmarket surveillance of devices; and
(3) identifies the changes in authority needed to make
those improvements, recognizing the legitimate differences
between devices and other medical products regulated by the
Food and Drug Administration.
(d) Transfer of Functions.--The functions and duties of the Office
of Surveillance and Epidemiology, including the Drug Safety and Risk
Management Drugs Advisory Committee, of the Food and Drug
Administration on the day before the date of enactment of this Act
shall be transferred to the Center for Postmarket Evaluation and
Research for Drugs and Biologics established under section 507 of the
Federal Food, Drug, and Cosmetic Act (as added by this section). The
Center for Postmarket Evaluation and Research for Drugs and Biologics
shall be a separate entity within the Food and Drug Administration and
shall not be an administrative office of the Center for Drug Evaluation
and Research or the Center for Biologics Evaluation and Research.
(e) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this Act (and the amendments made by this
Act)--
(1) $50,000,000 for fiscal year 2008;
(2) $75,000,000 for fiscal year 2009;
(3) $100,000,000 for fiscal year 2010;
(4) $125,000,000 for fiscal year 2011; and
(5) $150,000,000 for fiscal year 2012.
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