FDA: Most Industry Keep Up With Post-Marketing Information

Medical Research

There are far more drug firms that are completing what is known as a follow up than what the FDA originally thought. In fact, statistics are demonstrating that over 80% of the drug manufacturers that submitted post-marketing information to the FDA met their responsibilities and where compliant despite weaknesses in FDA's monitoring and tracking of post-marketing requirements. This FDA study indicated that most industry keeps up with post-marketing information.

Critics state that the post-approval studies, even when completed, did not necessarily provide useful long-term information about the safety and effectiveness of the drugs, even though the FDA study did indicate that most industry keeps up with post-marketing information. Often, the FDA approves drugs and devices for sale on condition that companies keep studying the products for possible side effects or other issues.

The study, which was completed under a contract with Booz Allen Hamilton and supported by additional funds from Congress, looked at the backlog of industry post-marketing studies for FDA approved drugs and biologics. What it discovered was most industry kept up with post-marketing information however, the FDA faces heavy critic from Congress and public health advocates for not ensuring companies submitted post-marketing reviews. A leading medical journal at the time said the lack of enforcement was putting patients at risk.


"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 FDA Amendments Act of 2007, the FDA must under-take such a review annually. The review showed that most industry keeps up with post-marketing information 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.

The report also makes recommendations for how the FDA can better monitor the reviews. Recommendations include standardizing the way companies submit their studies, designing specific objectives a study is supposed to meet and updating the database each time a final study is submitted. The important fact that cannot be overlooked is the FDA study does indicate that most industry keeps up with post-marketing information.

ABC News