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Postmarketing Requirements and Commitments: Legislative Background
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 postmarketing 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 postmarketing 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 postmarketing study commitments (64 FR 67207). After receiving and considering public comments, FDA published the final rule (PDF - 167KB) (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 postmarketing study commitment available to the public on the Internet. This Web site was initially created to make this information available. A separate Web site is available for postapproval studies for medical devices.
As a complement to the final rule, in February 2006, the Agency also issued a Guidance For Industry "Reports on the Status of Postmarketing Study Commitments - Implementation of Section 130 of the Food and Drug Administration Modernization Acot of 1997 (PDF - 46KB) to describe in greater detail the content, format, and timing of the annual postmarketing status reports on PMCs.
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 postmarketing 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.
Section 505(o) authorizes FDA to require certain postmarketing studies and clinical trials at the time of approval or after approval if FDA becomes aware of new safety information. Section 505(o) states that FDA may require postmarketing studies and clinical trials for any or all of three purposes:
- To assess a known serious risk related to the use of the drug
- To assess signals of serious risk related to the use of the drug
- To identify an unexpected serious risk when available data indicates the potential for a serious risk
A Guidance for Industry was posted in April 2011 “Postmarketing Studies and Clinical Trials – Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act" (PDF - 276KB).
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.