The Food and Drug Administrations debarment process seems to be nonexistent when it comes to excluding convicted felons from the drug-safety approval process, a report issued by Republican staff concluded.
The FDA lacks the full authority and the will to remove companies and individuals that were convicted of crimes related to the drug-approval process, according to the report. Debarred companies are often accused of crimes that include bribery, fraud, perjury, making false statements, blackmail and extortion.
This staff report shows in great detail the record of weaknesses in FDAs ability and authority to carry out its duties and to protect its own integrity, said Rep. Joe Barton (R-Texas), who released the report.
The investigation was spurred by Congress probe of the FDAs handling of the antibiotic drug Ketek, which is manufactured by Sanofi-Aventis and which was approved despite faulty clinical trials. Republican staff noted that Anne Kirkman-Campbell, a clinical investigator in a Ketek safety trial, had been convicted of a felony because of misconduct during the approval process, yet the FDA did not move to debar her until nearly three years after she had been incarcerated. Several FDA officials subpoenaed by the House Energy and Commerce Oversight and Investigations Subcommittee are scheduled to testify before the panel on the Ketek issue Feb. 12.
Debarment supplements the FDAs existing compliance instruments: injunctions, seizures, recalls, civil penalties and criminal sanctions. The agency values its authority under the debarment statute and pursues debarments while providing individuals with appropriate due process protections, the FDA responded in an e-mailed statement. -- by Jennifer Lubell
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