FDA review on postmarketing studies for approved drugs and biologics

FDA Study Indicates Most Industry Postmarketing Studies Meet Timelines

Makers of approved drugs and biologics generally are meeting their regulatory obligations and complete their postmarketing studies in a timely manner, according to a study released today by the U.S. Food and Drug Administration. A review of 1531 open postmarketing studies indicated that over 80 percent are proceeding according to the established timelines, have been submitted for FDA review, or have been determined by the FDA to have met their goals or are no longer needed.

The study, done under a contract with Booz Allen Hamilton and supported by additional funds from Congress, examined the backlog of industry postmarketing studies for FDA-approved drugs and biologics. The review found that most companies meet their obligations in a timely manner.

The study also recommended changes designed to improve the quality of the information submitted to the FDA, the timeliness of the FDA review, and the accuracy of the FDA's databases. The agency is evaluating the recommendations and already has made significant improvements based upon the study:

• Establishment of a postmarketing study development coordinator and a tracking coordinator within each new drug division. 
• Development of new Manuals of Policies and Procedures (MAPP) for development of postmarketing studies and tracking the status of postmarketing studies.
• Creation of a new postmarketing study database in the Document Archiving and Records Retention System (DARRTS) that includes increased capabilities for data capture, tracking, and generating reports related to postmarketing studies. This system was implemented the end of July 2009.

"New resources and directives from Congress have allowed us to complete this long-desired review," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "The data indicate that makers of approved drugs and biologics are generally meeting their regulatory obligations and are on track with their studies. To date, we have not identified any previously unknown serious safety issues from the submitted final study reports."

Under the Food and Drug Administration Amendments Act of 2007, the FDA must undertake such a review annually. The review showed that the industry has been initiating most studies on time and submitting final reports for many studies, as required.  Many of these reports are pending completion of a thorough FDA review. The FDA will continue to work with Booz Allen Hamilton to complete the agency's review of all submitted reports in a timely manner.

Manufacturers of drugs and biologics are also required to report to the FDA in a timely manner any serious safety issues that are identified from studies or other sources.