FDA’s Generic-Drug Reviews Criticized

The Food and Drug Administration lacks sufficient internal controls over generic drug review procedures “to maintain its integrity,” and such weaknesses have enabled some drug companies to receive preferential treatment, according to a report released Thursday.

The report, issued by the inspector general of the Department of Health and Human Services, said the FDA was able to favor some companies by assigning their applications to chemists who work rapidly, while punishing competitors by giving their applications to slower reviewers.

The FDA, the report said, “needs a quality-control system to ensure that applications are properly reviewed and that generic firms receive equitable treatment.”

The agency has been rocked in recent months by revelations that employees in its generics division accepted bribes from drug manufacturers to gain rapid approval of their drugs, and that at least one generic drug company falsified data submitted to the agency.

The FDA’s generics operation has been the focus of a federal probe by the U.S. attorney in Baltimore and by the House Energy and Commerce oversight subcommittee.

The report was requested by FDA Commissioner Frank E. Young and Rep. John D. Dingell (D-Mich.), chairman of the House Energy and Commerce Committee and of its oversight panel.

William Grigg, an FDA spokesman, said the agency welcomed the report. “We have independently seen some of these things ourselves,” he said. “We’re making changes, and we will shortly be providing the inspector general with a status report.”

The report also said the FDA has not established standard operating procedures for chemists. The lack of such procedures, it said, “may indirectly favor one company’s application for which a chemist may do a minimal review and adversely affect another company’s application for which a chemist may do an exhaustive review.”

‘Integrity, Fairness’

The agency does not have a quality-control system that “assures the fundamental integrity and fairness” of the drug review process, the report noted.

The report said the FDA “accepts that it has fast and slow reviewers,” but said the pace of the review process “could be made more equal if all reviewers worked from uniform review standards.”

Dingell could not be reached for comment. Rep. Thomas J. Bliley Jr. (R-Va.), ranking Republican on the oversight subcommittee, said the report “confirms that there are serious weaknesses in FDA’s generic drug review process” and that lawmakers would “pursue corrective legislation on a bipartisan basis” when the subcommittee finishes its investigation.

Last week, the agency proposed a list of internal changes designed to strengthen its generics program and asked Congress for more authority to punish drug companies that commit wrongdoing.

FDA spokesman Grigg said part of the agency’s new plan would ensure “that assignments were parceled out fairly so that there couldn’t be any favoritism.”