The 2008 Barton Report further concentrated FDA’s attention on GCPs
In February 2008, responding the Ketek case, Rep. Joe Barton’s (R-TX) staff issued a report citing the “weakness in FDA’s ability and authority to carry out its duties and to protect its own integrity”
The report stressed the agency’s failure to adequately pursue disqualification and debarment of clinical investigators
The report also focused on the agency’s lack of authority to debar brand name drug companies for misconduct related to clinical trials
The Barton report concluded with the following recommendations:
Congress should consider extending debarment provisions enacted in the Generic Drug Enforcement Act to name-brand companies
Congress should consider whether a company’s misconduct that occurs after a drug product is approved should be a basis for debarment
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