The US Food and Drug Administration says that the makers of approved drugs and biologics “generally are meeting their regulatory obligations” and completing postmarketing studies “in a timely manner”.

The agency made this claim following a review carried out by Booz Allen Hamilton (and supported by additional funds from the US Congress) which examined the backlog of post-approval studies. Of 1,531 open postmarketing studies, the consulting firm’s report indicated that over 80% are proceeding “according to the established timelines”, have been submitted for FDA review, or have been deemed by the agency to have met their goals or are no longer needed.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, noted that new resources and directives from Congress “have allowed us to complete this long-desired review”. Noting that drugmakers are generally on track with their studies, she added that “to date, we have not identified any previously unknown serious safety issues from the submitted final study reports.”

The study also recommended changes designed to improve the quality of the information submitted to the FDA, the timeliness of the review, and the accuracy of the agency’s databases. The FDA has already taken some of those suggestions on board, notably establishing a postmarketing study development coordinator and a tracking coordinator within each new drug division and it is also working on new “manuals of policies and procedures” to develop and track the status of postmarketing studies.

The agency is required to carry out an annual backlog review under the FDA Amendments Act of 2007.