FDA: Most Firms Meeting Postmarketing Study Timelines

More than 80% of pharmaceutical and biologics companies are completing their postmarketing studies and regulatory obligations in a timely manner. The finding is a result of a new US Food and Drug Administration study performed under contract with Booz Allen Hamilton and supported by Congress that reviewed 1531 open postmarketing studies submitted by pharmaceutical firms.

“New resources and directives from Congress have allowed us to complete this long-desired review,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research in press release. “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.”

The study included recommendations as to how companies may improve the quality of the information they submit FDA, the timeliness of the FDA review, and the accuracy of the FDA’s databases, including:

• 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 the development of postmarketing studies and for 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.

The agency says it will continue to work with Booz Allen Hamilton to complete its review of all submitted reports in a timely manner.