FDA Faulted for Spotty Oversight of Data Coming from Overseas
The FDA's approval of drugs is often based on study data from other countries.
June 24, 2010— -- WASHINGTON -- The U.S. Food and Drug Administration hasn't done enough to monitor clinical trial data coming from overseas sites and patients, which increasingly dominate the studies used to support drug applications in the United States, according to a report from the Department of Health and Human Services' inspector general.
More than three-quarters of the patients participating in clinical studies submitted for 121 drugs approved by the FDA in fiscal year 2008 were from foreign sites, according to the report, submitted by HHS Inspector General Daniel R. Levinson.
For 10 of these drugs, all the supporting clinical data came from overseas trials, wrote Levinson, whose staff audited all marketing applications approved that year.
Yet despite this heavy reliance on foreign data, less than 1 percent of trial sites outside the U.S. underwent FDA inspection, the audit indicated.
Moreover, the HHS investigators found, "sponsors are increasingly conducting early-phase clinical trials outside the United States without INDs [Investigational New Drug applications]," leaving the FDA unaware that these studies are taking place.
Levinson wrote that the FDA should step up its inspection of foreign trial sites and work with its equivalents in other countries to share inspection findings and future plans.
He also recommended that the FDA begin "taking steps to encourage sponsors to voluntarily consult with FDA on their clinical trial protocols or submit INDs to the agency" when they begin human drug testing overseas.
Finally, the report suggested that the FDA should require that trial data be submitted in a standardized electronic format, after investigators found that the agency was unable to find some trial data because of missing files and incomplete submissions from sponsors.
Indeed, the audit excluded eight applications approved that year because the FDA couldn't locate them.
Dr. Joshua Sharfstein, the FDA's deputy commissioner, in a memo published with the report, agreed with the recommendations and said the agency was addressing each of the problem areas.
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