FDA: Drugmakers & their post-marketing commitments
FDA is authorized to require drugmakers to conduct and report on postmarketing studies to assess known serious risks, safety signals or identify an unexpected serious risk.
Four years ago, the Food and Drug Administration Amendments Act went into effect and authorized the FDA to require drugmakers to conduct and report on postmarketing studies to assess known serious risks, safety signals or identify an unexpected serious risk. And there are two types of follow-ups: post-marketing studies that are required and those that drugmakers agreed to conduct.
To keep track, the FDA requires annual status reports to be submitted for each post-marketing requirement and post-marketing commitment within 60 days of the anniversary date of FDA approval of the drug. So how well are drugmakers doing at fulfilling their obligations? Well, in fiscal year 2011, 21 percent of NDA and ANDA reports and 41 percent BLA reports were not submitted on time. Of the reports due but not submitted on time, 100 percent of the NDA/ANDA and 56 percent of the BLA reports were submitted before the close of the fiscal year.
Meanwhile, most post-marketing requirements are progressing on schedule - 87 percent for NDAs and ANDAs, and 88 percent for BLAs. Similarly, most post-marketing commitments are also progressing on schedule - 80 percent for NDAs and ANDAs, and 75 percent for BLAs). Most of the post-marketing commitments that are currently listed in the database were developed before the postmarketing requirements section of FDAAA took effect, the agency notes.
The report, of course, is meant to highlight any problems with industry follow through. Drugmakers are sometimes criticized for failing to properly conduct these studies on a timely basis, potentially jeopardizing patient safety even as sales continue to mount. An example arose last month, when the FDA warned Merck for failing to submit an agreed-upon post-marketing study required to assess the risk of acute pancreatitis in its Januvia and Janumet diabetes meds (see this).
Meanwhile, former FDA commissioner Andy von Eschenbach last month proposed that the agency should approve drugs based on safety and leave efficacy testing for post-marketing studies, which generated debate, in part, over the willingness of the pharmaceutical industry to sufficiently adhere to such a requirement in a timely fashion (look here).
By Ed Silverman