CORPORATE CRIME REPORTER
FDA
Fails to Debar Convicts, Report Finds
22 Corporate Crime Reporter 7, February 12, 2008
The Food and Drug Administration (FDA) is failing to debar convicted criminals
in a timely manner.
That’s according to a report released today by House Energy and Commerce Committee’s Republican minority staff.
The Republican staff investigation was spurred on by hearings on the FDA’s handling of a drug called Ketek.
Dr. Anne Kirkman-Campbell, a clinical investigator in a Ketek safety trial, had been convicted of a felony under federal law because of misconduct during the approval process.
The FDA, however, did not move to debar her until nearly three years after she had been incarcerated.
“FDA’s failure to take action in a timely manner increases the risks of criminals continuing to operate in, and undermine, the drug regulatory process,” the report says.
“More than 15 years ago, Congress passed a law to let the FDA kick out companies and individuals from the drug industry convicted of crimes related to the FDA approval process,” said Congressman Joe Barton (R-Texas). “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. When it comes to excluding the worst of the worst – convicted felons – FDA’s debarment process seems to be non-existent. It is inexcusable that the FDA can’t quickly debar convicted felons.”
The report found that FDA lacks both full authority and the will to remove from the process companies and individuals convicted of crimes related to the drug approval process.
These companies and individuals can consequently continue to help move medical device and drug applications through the approval process.
Crimes resulting in debarment can include bribery, fraud, perjury, making false statements, blackmail, extortion.
The report found that the FDA has used its permissive debarment authority only nine times over 15 years.
From FDA enforcement reports for the three-year period (Fiscal Years 2003-2005), Republican staff investigators compiled a list of 40 individuals convicted of crimes who staff believes could have and should have been debarred by FDA.
There have been no debarments since Jan. 30, 2007.
The FDA can only debar generic drug makers, not brand-name companies.
The FDA lacks authority to debar a corporation when the misconduct by the corporation relates to a brand-name drug.
The report also found that even though FDA can debar generic drug companies, after more than 15 years of debarment authority, FDA has not debarred a single generic drug maker.
The FDA lacks authority to debar medical device companies or individuals involved with medical device companies who are convicted of crimes aimed at undermining the FDA regulatory process.
The staff review of FDA debarments shows that FDA has failed to pursue mandatory debarments against individuals in a timely manner, opening proceedings which can linger for years.
The report also found that debarment proceedings against individuals are inconsistent and haphazard. The minority staff uncovered cases where individuals convicted of a felony related to the development or approval of a drug product were not debarred, while other individuals with similar circumstances or convictions were debarred.
“In addition to bringing this problem to the administration’s attention, I will introduce legislation to reduce FDA’s budget when they don’t enforce the law,” Barton said.
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