Postmarket 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 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 - 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 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 (PDF - 46KB) 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]" (PDF - 84KB).  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.