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Internal Review Questions FDA's Commitment To Drug Safety

July 10, 2006

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An internal report has faulted the Food and Drug Administration for not aggressively following up with drug manufacturers to monitor their progress in conducting safety studies.

The Inspector General of the U.S. Department of Health and Human Services has conducted a review of FDA monitoring performance, finding 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 post-marketing study commitments is not a top priority," the study concluded.

Post-marketing studies are conducted once a drug has been approved for the marketplace. They can be important because the actual approval is often based on limited clinical trials. Aftermarket studies can reveal what unforeseen effects the drug is having among the population using it.

Though it was not revealed by an post-market study, problems with the pain reliever Vioxx did not emerge until the drug had been in use for a number of years. It was, in fact, another set of clinical trials that established a link between the popular arthritis drug made by Merck & Co. and an increased risk of heart attack and stroke.

According to the Inspector General's report, only about half of new drug applications approved from 1990 through 2004 included at least one commitment for a postmarketing study.

But the report concludes that the FDA cannot readily identify what kind of progress drug companies are making with their studies. The report further found that even the status reports that are completed sometimes leave out data that would help the agency monitor the progress of safety studies.

The FDA took issue with the report, saying the conclusion that it cannot monitor safety studies is not accurate.

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