Two or three sides of the coin

Two or three sides of the coinLast week, the FDA submitted to the Federal Register its annual Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies. The idea is that once companies commit to performing post-approval studies, they must report annually on their progress on those commitments. FDA doesn't have the staff or power to compel the companies to fulfill their commitments, so the report provides an important source of information and potential pressure on companies to do what they promise. This year's report shows the following for drugs (excluding biologics): Of 1231 open postmarketing commitments:

• 65% are "pending"
• 19% are "ongoing"
• 2% are "delayed"
• 14% are "submitted"

The pharmaceutical industry association (PhRMA) made the following statement:

The FDA'Â’s annual report on the performance of post-market study commitments should not be distorted. The report clearly says that 65 percent of studies are pending in accordance to mutually agreed upon time schedules between the FDA and individual companies. To be clear, pending does not mean delayed. It does mean, however, that the immense and vitally important tasks of developing research protocols, finding investigators and researchers and even recruiting patients to participate in the study is in process.According to the FDA report, just 2 percent of post-market commitments are delayed. It should not be assumed that delayed means there is fault or blame. Frankly, it may mean that due to uncontrollable circumstances, such as difficulty in patient recruitment for on-going clinical trials, moving forward at this time is simply not possible or is delayed.

They must have been reacting to Public Citizen, which published the following:

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.

Who's right? In this case, I think Public Citizen's analysis is accurate. Consider the definitions:

• Pending: The study has not been initiated, but does not meet the criterion for delayed
• Delayed: The study is behind the original schedule

It's a bit curious. If a study has not been initiated and yet is not behind its schedule, then the schedules must be awfully loose. PhRMA seems to be hiding behind semantics.One exaggeration of Public Citizen --the information is not exactly "buried." It's in a table at the end of a 1 1/2 page report.