FDA lets drug makers slide

Drug makers routinely fail to file status reports with the federal government that show what kind of progress they have made in conducting 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 (Food and Drug Administration),” 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,” said Andrew von Eschenbach, the FDA’s acting commissioner.

Investigators said that even completed status reports often lacked information that would be useful in monitoring the progress of studies.

But von Eschenbach said the agency cannot instruct drug applicants to provide additional, meaningful information in their status reports. “A provision for additional information would require that new regulations be written,” he said.

However, a database was being redesigned to improve data entry and retrieval involving the status reports, von Eschenbach said.

An official at the trade group that represents drug makers, the Pharmaceutical Research and Manufacturers of America, said the organization did not have immediate comment on the report.


On the Net:

HHS Inspector General report: http://oig.hhs.gov/oei/reportsh/oei-01-04-00390.pdf

© 2006 The Associated Press