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news.US Representative Joe Barton, the ranking member of the House energy and commerce committee, has released a report highlighting the drawbacks in the FDA's debarment process, according to scripnews.com.
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The report includes a list of 40 individuals convicted of crimes between fiscal years 2003 and 2005 who it maintains the FDA should have debarred. Overall, the report finds that since the 1991 law providing for debarments was passed, the FDA has debarred 71 individuals (about half related to the generic drug scandal), but has taken such action against only 13 individuals in the past five years.
According to the report, the FDA’s failure to debar clinical investigators convicted of wrongdoing may lead to gradual undermining of the drug regulatory process. The report also flayed the FDA for lacking authority and will to debar companies and individuals convicted of crimes related to the drug-approval process, which can include bribery, fraud, perjury, blackmail and extortion.
The report also contended that the FDA has never debarred a generic pharmaceutical company and lacked authority to debar a company when its misconduct relates to a brand-name drug.