|
Postmarket Study and Clinical Trial
Requirements and Commitments
This Web site is intended to provide information to the public on postmarket requirements and commitments. The phrase postmarket requirements and commitments refers to studies and clinical trials that sponsors conduct after approval to gather additional information about a product's safety, efficacy, or optimal use. Some of the studies and clinical trials may be required; others may be studies or clinical trials a sponsor has committed to conduct.
Search the database for:
More Information:
I. Introduction
This Web site is intended to provide information to the public on postmarket requirements and commitments. The phrase postmarket requirements and commitments refers to studies and clinical trials that sponsors conduct after approval to gather additional information about a product's safety, efficacy, or optimal use.
- The Agency has made available on this Web site a searchable database of information on postmarket studies and clinical trials for drugs and biological products.
- Frequently asked questions and answers have been developed to provide additional guidance.
Postmarket requirements (PMRs) include studies and clinical trials that sponsors are required to conduct under one or more statutes or regulations (see Background).
Postmarket commitments (PMCs) are studies or clinical trials that a sponsor has agreed to conduct, but that are not required by a statute or regulation. In the past, we have used the word commitment to cover both required and not required studies and clinical trials. Now, because commitments and requirements are treated differently under the law, we are using terminology that distinguishes between studies and clinical trials that are required and those that a sponsor agrees to conduct that are not required.
Commitments containing proprietary information (e.g., those to evaluate chemistry or manufacturing and control issues) are not included on this Web site.
II. Background (The 1997 Modernization Act and the 2007 FDAAA)
This Web site was first created after Congress passed The Food and Drug Administration Modernization Act of 1997 (Modernization Act), which contained requirements for FDA and sponsors with regard to postmarket studies. Section 130(a) of the Modernization Act added a new section 506B to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356b) that requires sponsors of approved drugs and biological products to report to FDA annually on the progress of their postmarket study commitments (PMCs), which was defined to include required studies and clinical trials and agreed upon commitments. Under section 506B(b) and (c), FDA is required to track these PMCs and report on them annually in the Federal Register.
Following the passage of the Modernization Act, on December 1, 1999, FDA published a proposed rule on postmarket study commitments (64 FR 67207). After receiving and considering public comments, FDA published the final rule (PDF  ) (65 FR 64607) on October 30, 2000. In the preamble to the proposed and final rules, FDA announced its intention to make basic information about the status of each postmarket study commitment available to the public on the internet. This Web site was initially created to make this information available.
As a complement to the final rule, in February 2006, the Agency also issued a guidance for industry to describe in greater detail the content, format, and timing of the annual postmarket status reports on PMCs. For more information, please read: "Report to Congress: Reports on Postmarketing Studies [FDAMA 130]". A separate Web site is available for postapproval studies for medical devices
On September 27, 2007, the President signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85). Section 901, in Title IX of FDAAA, created section 505(o) of the Federal Food, Drug, and Cosmetic Act (the Act), which authorizes FDA to require certain studies and clinical trials1 for prescription drugs and biological products approved under section 505 of the Act or section 351 of the Public Health Service Act. This new authority became effective on March 25, 2008.
Section 901, also requires an applicant to provide certain information to FDA regarding required postmarket studies or clinical trials. Information must include a timetable for completion and periodic reports on the status of the study/clinical trial, including whether any difficulties have been encountered in completing the study/clinical trial.
1FDAAA makes a new distinction between study and clinical trial. Previous laws, regulations, and practice have used the terms studies and trials interchangeably. Although Section 506B uses studies to describe PMCs that must be reported annually, this term also included clinical trials.
III. What Studies or Clinical Trials Can Be Required Today?
The studies and clinical trials that can be required under FDAAA join the types of studies and clinical trials that FDA could require before FDAAA. Before FDAAA, FDA could require the following studies or clinical trials:
- Postmarket studies or clinical trials to demonstrate clinical benefit for drugs approved under the accelerated approval requirements in 21 CFR Subpart H (21 CFR 314.510 and 601.41)
- Deferred pediatric studies (21 CFR 314.55(b) and 601.27(b)), where studies are required under the Pediatric Research Equity Act (PREA)
- Studies or clinical trials to demonstrate safety and efficacy in humans that must be conducted at the time of use of products approved under the Animal Efficacy Rule (21 CFR 314.610(b)(1) and 601.91(b)(1))
Now, under FDAAA, postmarket studies and clinical trials also can be required to:
- Assess a known serious risk related to the use of the drug
- Assess signals of serious risk related to the use of the drug
- Identify an unexpected serious risk when available data indicate the potential for a serious risk
IV. Annual Report in the Federal Register
The 1997 Modernization Act required FDA to publish annually a notice in the Federal Register containing information on the performance of postmarket requirements and commitments. The annual notice is intended to summarize the information in the postmarket requirements and commitments database. 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 postmarket requirements and commitments in the Agency database. The information in the Federal Register is updated annually, whereas the numbers on the Web site is updated quarterly.
V. Final Report on the Independent Evaluation of FDA's Prescription Drug User Fee Act III – Evaluations & Initiatives
As part of ongoing initiatives to improve the process for developing and tracking postmarket requirements and commitments, the FDA commissioned Booz Allen Hamilton (BAH) in 2006 to conduct an independent analysis of the Agency's postmarket processes and procedures. The final report, describing the results of their analysis and recommendations for improvement, was released in March 2008. Final Report: Independent Evaluation of FDA's Prescription Drug User Fee Act III – Evaluations & Initiatives (PDF - 369 KB)
Based on the BAH report, and on the new authority to require certain postmarket studies provided under the 2007 (FDAAA), the FDA is developing and implementing procedures to further improve our processes for tracking postmarket requirements and commitments.
The FDA also published, on March 9, 2009: Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments (MAPP 6010.9).
VI. What Has Changed on this Web Site Since the Enactment of FDAAA?
This Web site contains information about postmarket studies and clinical trials previously reported under the Modernization Act (both requirements and commitments), and it also contains information about studies and clinical trials required under FDAAA. Some changes have been made.
- PMR refers to postmarket requirements, studies or clinical trials the sponsor is required to conduct
- PMC now refers to postmarket commitments, studies or clinical trials to which sponsors commit but that they are not required to conduct
- Changes have been made to the searchable database of information on postmarket studies and clinical trials for drugs and biological products.
- Frequently asked questions have been updated to reflect the changes resulting from FDAAA.
Some
files may require Adobe Acrobat Reader.
Back to Top
Date created: May 23, 2003 ; Last updated:
April 1, 2009 |
