Postmarketing Study Commitments
Introduction
Search for Postmarketing Study Commitments for Human Drugs
Post Approval Studies for Medical Devices
This Web site is intended to provide information to the public on
postmarketing study commitments, also called phase 4 commitments.
Postmarketing study commitments are studies — required of or
agreed to by a sponsor — that are conducted after FDA has approved
a product for marketing (e.g., studies requiring the sponsor to
demonstrate clinical benefit of a product following accelerated
approval). FDA uses postmarketing study commitments to gather
additional information about a product's safety, efficacy, or optimal
use. Agreements with sponsors to conduct postmarketing studies can be
reached either before or after FDA has granted approval to a sponsor
to market a product.
The Food and Drug Administration Modernization Act of 1997 ("the
Modernization Act") became law on November 21, 1997. Section 130(a) of
Title I of the Modernization Act added a new provision (section 506B)
on postmarketing studies to the Federal Food, Drug, and Cosmetic Act
356b ("the Act") (21 U.S.C. 356b). This new provision requires
sponsors of approved drugs and biological products to report to FDA
annually on the progress of their postmarketing study commitments. In
addition, FDA was required to do the following:
- develop and publish regulations prescribing the format of the
reports sponsors are to submit to FDA
- report annually in the Federal Register on the
performance of postmarketing commitment studies
- report to Congress on the studies by October 1, 2001
The Agency has made good progress in implementing the postmarketing
studies requirements in section 506B of the Act.
Regulations
A proposed rule on postmarketing study commitments was published on
December 1, 1999 (64 FR 67207). After receiving and considering public
comments, the
final rule
[optional format:
PDF ]
was published on October 30, 2000 (65 FR 64607). In the preamble to
the proposed and final rules, FDA announced its intention to make
basic information about the status of each postmarketing study
commitment available to the public on the Internet. The Agency has
developed and is making available on this Web site a searchable
database of information on postmarketing studies for drugs and
biological products.
As a complement to the final rule, the Agency also issued in
February 2006 a guidance for
industry
to describe in greater detail the content, format, and timing of the
postmarketing study reports.
Report to Congress
The
Report to Congress discusses the background of and need for the
postmarketing study commitment effort and contains (1) a summary of
the reports submitted by sponsors under section 506B, (2) an
evaluation of the performance of sponsors in fulfilling the
agreements, (3) an evaluation of the timeliness of FDA's review of the
postmarketing studies, and (4) legislative recommendations regarding
postmarketing studies.
Annual Report in the Federal Register
Section 506B required FDA to publish annually a notice in the
Federal Register containing information on the performance of
postmarketing commitments. The annual notice is intended to summarize
the information in the postmarketing study commitments database.
Commitments containing proprietary information (e.g., those to
evaluate chemistry or manufacturing and control issues) are not
included on the Web site. Note that the numbers that publish in the
annual Federal Register notice cannot be compared to the
numbers resulting from searches of the database on the Web site. The
annual Federal Register notice incorporates totals for all
postmarketing study commitments in the Agency database. The
information in the Federal Register will be updated annually,
whereas the numbers on the Web site will be updated quarterly.
Final Report on the Postmarketing Commitments Study
As part of the Agency’s ongoing initiatives designed to ensure a
more standardized and efficient approach for how requests and requirements
for postmarketing study commitments (PMCs) are developed and tracked
within the Agency, the FDA commissioned Booz Allen Hamilton (BAH)
in 2006 to conduct an independent analysis of the Agency's PMC processes
and procedures. The final report, describing the results of their
analysis and recommendations for improvement, was released in March
2008. Based on the BAH report, and on the new authority to require
certain postmarketing studies provided under the Food and Drug Administration
Amendments Act of 2007 (FDAAA), the FDA is developing and implementing
procedures to further improve our processes for developing and tracking
postmarketing requirements and commitments.
Final
Report: Independent
Evaluation of FDA's Prescription Drug User Fee Act III – Evaluations & Initiatives (PDF -
369 KB)
The Web Site
The Web site contains the basic information that FDA committed to
make available to the public. The information currently available to
search includes only postmarketing study commitments that have been
reviewed for accuracy. This site does not include commitments
containing proprietary information.
The Web site will be updated quarterly (in July, October, January,
and April), at which time additional commitments will be added and the
status of existing commitments updated. More details about the
specific information that is included on the site are provided on the
search page and as part of the "Frequently Asked Questions (FAQ)."
If you have any questions or comments related to this Web site,
please send them to the Postmarketing Study Commitment Coordinator at
pmcweb@fda.hhs.gov.
Search for Postmarketing Study Commitments for Human Drugs
Post Approval Studies for Medical Devices
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Date created: May 23, 2003 ; Last updated:
April 25, 2008 |