Progress on post-marketing commitments must be reported to the FDA annually. Earlier this month, the FDA published the most recent figures as of September, 2006.

The FDA is tracking more than 1,600 trials with postmarketing commitments from industry. The figures just track what the FDA has mandated for scientific purposes and do not include studies undertaken for chemical, manufacturing or other reasons.

The most glaring numbers are of “pending” post-marketing trials: for new drug applications (NDA) and abbreviated new drug applications (ANDA), there are 899 trials (71 percent of those outstanding) tallied as belated. Biologic license applications (BLA) are more likely to be on schedule, with just 127 studies (or 34 percent) tallied as belated. With NDAs and ANDAs, just 15 percent of studies are on or ahead of schedule; the same figure for BLAs is 21 percent.

Even the required paperwork around the status of a postmarketing promise is often late, about half the time for BLAs and 37 percent of the time with NDAs and ANDAs.

The numbers are certain to be aired in the forthcoming Washington debate about whether the FDA has the resources or the desire to hold sponsors to their post-marketing promises. Within the FDA, the numbers will be viewed as further proof the agency needs additional resources or new rules. For politicians, the numbers will be viewed as another sign the current system is broken. And in industry, it’s privately understood that some of the delays can be traced to FDA staffers overwhelmed with other duties, resulting in months or years passing before the agency comments on a sponsor’s plans for another trial.

Jeffrey Shuren, assistant FDA commissioner for policy, is listed as the source of the data. The Federal Register notes that that annual report cannot be reconciled with similar data published online. The web-based figures are updated quarterly.