FDA, Big Pharma and those pesky post-marketing studies

BigPharma routinely fails to file status reports with the FDA that show what kind of progress they have made in conducting post-marketing safety studies.

That's the conclusion of a review from the inspector general for the Health and Human Services Department. Investigators found that 35 percent of status reports that drug makers were supposed to file in fiscal year 2004 were missing entirely or contained no information on agreed-to studies.

"Monitoring postmarketing study commitments is not a top priority at the FDA," the investigators concluded. Such studies are considered important because they can shed light on the safety and effective use of drugs. The FDA requires all new drugs to undergo clinical testing, but trials often involve relatively small numbers of people, so the FDA frequently ask drug makers to conduct postmarketing studies.

Indeed, about half of new drug applications approved from 1990 through 2004 involved at least one commitment for a postmarketing study. Yet, the FDA cannot readily identify what kind of progress drug companies are making with their studies, the investigators said.

The FDA disagreed with that assessment. "While we embrace several recommendations for improvement that are outlined in the report, we do not agree that FDA cannot readily identify whether or how timely postmarketing study commitments are progressing," Andrew von Eschenbach, FDA acting commissioner, said.

Good point Andy. But that's not the issue. Big Pharma agree to these studies but then they end up not being done! See here.