Report shows FDA slow in generics application reviews

6/16/2008

WASHINGTON According to a report by the Department of Health and Human Services’ inspector general Daniel Levinson, the Food and Drug Administration failed to review nearly half the applications from generic drug manufacturers on time, as reported by Reuters.

The report also found that the agency approved or tentatively approved just 4 percent of generic applications reviewed in 2006, rejecting the majority because they did not meet the FDA’s standards.

The inspector’s office looked at the FDA’s review times in 2006 for 989 generic drug applications and found that 46 percent of them were not fully evaluated within the 180-day period allowed by law. Among a sample of 105 delayed applications, the agency did not even begin to review 70 percent of them until after the 180-day period had ended, the report found.

Part of the problem, the inspector said, is the way FDA officials prioritize applications. The agency reviews them on a “first-in, first-reviewed” policy rather than first tackling clear-cut applications that are not bogged down with patents or exclusivity issues that complicate the process. It takes the FDA a median time of nearly 17 months to approve generic applications, according to the report.

The FDA, in comments submitted to Levinson, said the agency was already implementing some of the report’s recommendations to improve its review process. It also said it was working with the industry to have drug makers submit more easily reviewed applications.

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