Debarment for criminal companies?
This article was originally published in The Gray Sheet
Executive Summary
FDA should have the authority to kick criminal medical device companies and involved individuals out of the regulatory process, a Feb. 11 staff report from House Energy and Commerce Committee ranking member Joe Barton, R-Texas, says. Presently, only companies or individuals from the generic drug industry can be debarred if they are convicted of bribery, fraud, perjury or other crimes related to the FDA regulatory process. The report says the debarment provisions in the Generic Drug Enforcement Act, originally passed more than 15 years ago, should also extend to biologic, name-brand drug and animal drug companies. FDA has only used its debarment authority nine times, and has never debarred a company