Statement of Peter Lurie, Deputy Director, Public Citizen’s Health Research Group

Although a Food and Drug Administration (FDA) report released today lists just 2 percent of post-marketing commitments as “delayed,” buried in that report is evidence of just how poorly the post-marketing commitment requirements are being enforced.

A full 65 percent of all commitments are listed as “pending,” meaning that they have not even been initiated. This can be possible only if companies are given extremely long times to initiate studies or have never been initiated but are not listed as “delayed.” Moreover, 14 percent of commitments are listed as “submitted,” without any indication of whether they have been submitted late. Thus this annual report gives little indication of the true fate of post-marketing commitments.

The underlying problem is that the FDA has little ability to enforce these commitments, short of withdrawing approval for the drug – an outcome that may not serve the public health well. The great majority of post-marketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion.

The FDA needs the ability to impose civil monetary penalties against companies that fail to complete their commitments in a timely fashion.