FDA Has Not Appropriately Debarred Individuals, Pharmaceutical Companies Convicted Of Crimes, Report Finds

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Malpractice / Litigation
Article Date: 13 Feb 2008 - 10:00 PDT

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FDA has not appropriately debarred a number of individuals and pharmaceutical companies convicted of crimes from participation in the agency approval process for medications, according to a report presented on Monday by House Energy and Commerce Committee Republicans, Bloomberg/New York Times reports (Bloomberg/New York Times, 2/12). FDA for the past 15 years has had the authority to issue mandatory or permissive debarments, based on the severity of the crimes involved.

The report, drafted by Republican committee staff members, lists 40 individuals convicted of crimes between fiscal years 2003 and 2005 who they maintain FDA should have debarred. According to the report, FDA has debarred a total of 71 individuals but has taken such action against only 13 individuals in the past five years. FDA has never debarred a generic pharmaceutical company and does not have the authority to take such action against brand-name pharmaceutical or medical device companies, according to the report.

The report said, "It is doubtful that this is simply a matter of resources," as "other agencies have been able to start and complete debarments promptly." The report attributed the problem in part to the five-year period that FDA has to issue debarments after convictions. The report indicated that the five-year period might "give the agency an incentive to be lax," according to CongressDaily.

Committee ranking member Joe Barton (R-Texas) said, "This staff report shows in great detail the record of weaknesses in FDA's ability and authority to carry out its duties and to protect its own integrity." Barton has asked his staff to begin to draft legislation to address the problem, an aide said. In the event that FDA does not take action to address the problem, Barton said that he will seek to reduce the agency budget (Edney, CongressDaily, 2/12).

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