[Federal Register Volume 73, Number 60 (Thursday, March 27, 2008)]
[Notices]
[Pages 16313-16314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-6201]
[[Page 16313]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0174]
Identification of Drug and Biological Products Deemed to Have
Risk Evaluation and Mitigation Strategies for Purposes of the Food and
Drug Administration Amendments Act of 2007
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing this notice
to notify holders of certain prescription new drug and biological
license applications that they will be deemed to have in effect an
approved risk evaluation and mitigation strategy (REMS) under the Food
and Drug Administration Amendments Act of 2007 (FDAAA). Holders of
applications deemed to have in effect an approved REMS are required to
submit a proposed REMS to FDA.
DATES: Submit proposed REMSs to FDA by September 21, 2008.
ADDRESSES: Written communications regarding the applicability of this
notice to a specific product should be identified with Docket Number
FDA-2008-N-0174 and submitted to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic communications to http://www.regulations.gov. Information about FDA implementation of FDAAA is
available on the Internet at http://www.fda.gov/oc/initiatives/advance/fdaaa.html.
FOR FURTHER INFORMATION CONTACT: Mary Dempsey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4326, Silver Spring, MD 20993-0002, 301-
796-0147.
SUPPLEMENTARY INFORMATION:
I. Introduction
On September 27, 2007, the President signed into law FDAAA (Public
Law 110-85). Title IX, subtitle A, section 901 of FDAAA created new
section 505-1 of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 355-1). Section 505-1(a) of the act authorizes FDA to require
persons submitting certain applications\1\ to submit and implement a
REMS if FDA determines that a REMS is necessary to ensure that the
benefits of a drug outweigh the risks of the drug and informs the
holder of the application for the drug of the determination. Section
909 of FDAAA provides that Title IX, subtitle A takes effect 180 days
after its enactment, which is March 25, 2008.
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\1\ Section 505(p)(1) of the act (21 U.S.C. 355(p)(1)) states
that section 505-1 of the act applies to applications for
prescription drugs approved under section 505(b) or (j) of the act
and applications approved under section 351 of the Public Health
Service Act (42 U.S.C. 262).
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FDAAA also contains REMS requirements for drug and biological
products approved before the effective date of Title IX, subtitle A.
Section 909(b)(1) of FDAAA specifies that a ``drug that was approved
before the effective date of this Act is * * * deemed to have in effect
an approved risk evaluation and mitigation strategy under section 505-1
of the Federal Food, Drug, and Cosmetic Act * * * if there are in
effect on the effective date of this Act elements to assure safe use--
(A) required under section 314.520 or section 601.42 of title 21, Code
of Federal Regulations; or (B) otherwise agreed to by the applicant and
the Secretary [of Health and Human Services] for such drug.''
Section 909(b)(3) of FDAAA states: ``Not later than 180 days after
the effective date of this Act, the holder of an approved application
for which a risk evaluation and mitigation strategy is deemed to be in
effect * * * shall submit to the Secretary a proposed risk evaluation
and mitigation strategy. Such proposed strategy is subject to section
505-1 of the Act as if included in such application at the time of
submission of the application to the Secretary.''\2\
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\2\ Title IX, subtitle A of FDAAA, which includes section 909,
takes effect March 25, 2008; 180 days after that date is September
21, 2008.
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Section 909(b)(2) of FDAAA states that a REMS for a drug deemed to
have a REMS consists of the timetable required under section 505-1(d)
of the act and any additional elements under section 505-1(e) and (f)
of the act in effect for the drug on the effective date of FDAAA.
The purpose of this notice is to identify those drugs that FDA has
determined will be deemed to have in effect an approved REMS and to
notify holders of applications for such drugs that they are required to
submit a proposed REMS by September 21, 2008. FDA is developing
guidance on the preferred content and format of a proposed REMS
required to be submitted under section 909(b) of FDAAA and will issue
it as soon as possible.
II. List of Drug and Biological Products Deemed to Have a REMS
Drug and biological products deemed to have in effect an approved
REMS are those that on March 25, 2008 (the effective date of Title IX,
subtitle A of FDAAA), had in effect ``elements to assure safe use.''
``Elements to assure safe use'' include the following: (1) Health care
providers who prescribe the drug have particular training or
experience, or are specially certified; (2) pharmacies, practitioners,
or health care settings that dispense the drug are specially certified;
(3) the drug is dispensed to patients only in certain health care
settings, such as hospitals; (4) the drug is dispensed to patients with
evidence or other documentation of safe use conditions, such as
laboratory test results; (5) each patient using the drug is subject to
certain monitoring; or (6) each patient using the drug is enrolled in a
registry (see section 505-1(f)(3) of the act).
Some applications approved before the effective date of FDAAA Title
IX, subtitle A contain these elements to assure safe use.\3\ Some of
these applications were approved under Sec. 314.520 (21 CFR 314.520)
or Sec. 601.42 (21 CFR 601.42). Others were not approved under part
314, subpart H or part 601, subpart E, but still contain elements to
assure safe use that were agreed to by the applicant and the Secretary
for such drug. Since 2005, these elements typically appeared in
approved risk minimization action plans (RiskMAPs) (see the guidance
for industry entitled ``Development and Use of Risk Minimization Action
Plans'' (70 FR 15866, March 29, 2005)).
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\3\ These plans sometimes contain other elements to minimize
risk such as a Medication Guide (21 CFR part 208) or a
communication/educational plan for health care providers or
patients. A drug will not be deemed to have a REMS if it has only a
Medication Guide, patient package insert, and/or communication plan
(see section 505-1(e)(2) and (e)(3) of the act).
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FDA has reviewed its records to identify applications that were
approved before the effective date of Title IX of FDAAA with elements
to assure safe use and has identified the drug and biological products
listed in table 1 of this document as those that will be deemed to have
in effect an approved REMS.
[[Page 16314]]
Table 1.--Products Deemed to Have in Effect an Approved REMS
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Generic or Proper Application Date of
Name Brand Name Number\1\ Approval\2\
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Abarelix Plenaxis\3\ NDA 21-320 11/25/2003
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Alosetron Lotronex NDA 21-107 02/09/2000
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Ambrisentan Letairis NDA 22-081 06/15/2007
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Bosentan Tracleer NDA 21-290 11/20/2001
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Clozapine Clozaril NDA 19-758 09/26/1989
ANDA 74-949 11/26/97
ANDA 75-417 5/27/99
ANDA 75-713 11/15/02
ANDA 75-162 4/26/05
ANDA 76-809 12/16/05
Fazaclo ODT NDA 21-590 02/09/2004
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Dofetilide Tikosyn NDA 20-931 10/01/1999
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Eculizumab Soliris BLA 125166 03/16/2007
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Fentanyl PCA Ionsys\3\ NDA 21-338 05/22/2006
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Fentanyl citrate Actiq NDA 20-747 11/04/1998
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Isotretinoin Accutane NDA 18-662 05/07/1982
Amnesteem ANDA 75-945 11/2002
Claravis ANDA 76-135 04/2003
ANDA 76-356 04/2003
Sotret ANDA 76-041 12/2002
ANDA 76-503 06/2003
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Lenalidomide Revlimid NDA 21-880 12/27/2005
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Mifepristone Mifeprex NDA 20-687 09/28/2000
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Natalizumab Tysabri BLA 125104 11/23/2004
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Small pox ACAM2000 BLA 125158 08/31/2007
(Vaccinia)
Vaccine, Live
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Sodium oxybate Xyrem NDA 21-196 07/17/2002
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Thalidomide Thalomid NDA 20-785 07/16/1998
NDA 21-430
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\1\ New drug application (NDA), abbreviated new drug application (ANDA),
biologics license application (BLA).
\2\ The original date of approval of the drug. FDA may have required
elements to assure safe use at a later date.
\3\ Product is not currently marketed in the United States.
FDA is further asking members of the public to please notify the
agency if they are aware of applications that have not been identified
in this document and that they believe should be deemed to have in
effect an approved REMS. Please provide the information to Mary
Dempsey, Risk Management Coordinator (see the FOR FURTHER INFORMATION
CONTACT section of this document).
Any application holder that believes its product identified in this
notice should not be on the list of drug or biological products that
will be deemed to have in effect an approved REMS should submit a
letter identified with Docket Number FDA-2008-N-0174 to the Division of
Dockets Management (see ADDRESSES) stating why the application holder
believes its product was improperly identified in this notice. FDA will
notify the application holder within 30 days of receipt of the letter
of its determination.
Dated: March 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-6201 Filed 3-26-08; 8:45 am]
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