The Federal Food, Drug and Cosmetic Act's (FFDCA) voluntary debarment provision applicable to generic drugs is the focus of a bill recently introduced in Congress by Representative Joe Barton, R-Texas, ranking member of the House Energy and Commerce Committee. The proposed legislation (H.R. 6378) broadens both the depth of enforcement options available to the FDA and the scope of individuals and companies that fall under such authority.
Debarment restricts an individual or company from providing services in any capacity to a person or entity that has an approved or pending drug product application. Generic drug companies must certify as part of their Abbreviated New Drug Application (ANDA) filing that they have not used and will not use the services of any debarred person or entity in connection with the drug product application.
Currently, the FDA has only permissive debarment authority over generic drug companies and related individuals, and then only as they are associated with felonies involving generic drug development or approval. Rep. Barton's bill would require mandatory debarment in certain instances and adds breadth by expanding the scope of felony convictions to include those associated with the "regulation of" a drug, and by including brand name drug and medical device companies and related individuals under the FDA's debarment authority.
The bill, entitled the Strengthening of FDA Integrity Act of 2008, also tightens the time within which the FDA must begin debarment proceedings from the current five-year limit to one year following a felony conviction. A congressional staff report found that the FDA has not debarred a single generic drug company in the 15 years it has had the authority to do so, and where the FDA has attempted to pursue individuals in debarment proceedings, it has often failed to meet the five-year deadline.