The U.S. Food and Drug Administration has started its Secure Supply Chain Pilot Program to enhance the security of imported drugs.
In August 2013, FDA published a Federal Register
notice asking companies to volunteer for the two-year program. The agency has since pre-qualified 13 companies to participate. These companies will receive expedited entry for the importation of up to five selected drug products into the United States.
The purpose of the pilot is to “evaluate resource savings that will allow the agency to focus imports surveillance resources on preventing the entry of high-risk drugs that are the most likely to compromise the quality and safety of the U.S. drug supply,” the agency said.
“By creating incentives for manufacturers to adopt best practices for supply chain integrity, we can enhance the quality and safety of imported drugs,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in a statement. “The program also allows the FDA to focus resources on the areas with the greatest potential risk to consumers.”
During these next two years, FDA will evaluate the pilot’s effectiveness at enhancing imported drug compliance with FDA regulations and the security of the drug supply chain. If the agency finds the pilot to be effective, a more permanent program may be established and possibly extended to additional participating companies.
The 13 pharmaceutical companies approved for pilot program are AbbVie, Allergan, Astellas U.S. Technologies, Bristol-Myers Squibb Co., Celgene Corp., GE Healthcare, GlaxoSmithKline, Merck Sharp & Dohme Corp., Mylan Pharmaceuticals, Novartis Pharmaceuticals Corp., Pfizer, Teva Pharmaceutcials USA, and Watson Laboratories.
FDA said each of the companies met multiple participation conditions, including:
- Committing to comply with requirements of the Food, Drug, and Cosmetics Act (FDCA).
- Having a validated secure supply chain protocol per the U.S. Customs and Border Protection’s Customs-Trade Partnership Against Terrorism (C-TPAT) program.
- Having a plan in place to quickly correct potential problems the FDA identifies regarding importation of specific products.
- Having effective recall and corrective action plans in place.
- Maintaining control over their drugs from the time of manufacture abroad through entry into the United States.