The Food and Drug Administration (FDA) is loosening the regulatory controls for 13 pharmaceutical companies that will receive expedited entry for drugs they are importing into the United States.
As a part of the Secure Supply Chain Pilot Program, these “highly vetted” companies will receive more responsibility for keeping their own supply chains in line so the agency can focus more attention on preventing other, unapproved, drugs that are misbranded and adulterated from crossing the border.
The companies are as follows:
- AbbVie Inc.,
- Allergan Inc.,
- Astellas U.S. Technologies Inc.,
- Bristol-Myers Squibb Company,
- Celgene Corporation,
- GE Healthcare Inc.,
- GlaxoSmithKline LLC,
- Merk Sharp & Dohme Corporation,
- Mylan Pharmaceuticals Inc.,
- Novartis Pharmaceuticals Corporation,
- Pfizer Inc.,
- Teva Pharmaceuticals USA Inc. and
- Watson Laboratories Inc.
“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. “The program also allows the FDA to focus resources on the areas with the greatest potential risk to consumers.”
During these next two years, the FDA will evaluate the program’s effectiveness at enhancing imported drug compliance with FDA regulations and the security of the drug supply chain. If the FDA determines the program to be effective, a more permanent program may be established and possibly extended to additional participating companies.
Each of the 13 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; and,
• Maintaining control over their drugs from the time of manufacture abroad through entry into the United States.
“We’re still going to be looking at them, but we have a greater degree of confidence that their drugs are not going to need to be as thoroughly vetted as others,” FDA spokesman Christopher Kelly said.
“We’re still going to keep an eye on everything that’s coming in,” Kelly said. “We’re going to maintain oversight on them. They’ll still be under our regulatory guidelines. If a compliance issue comes up, we’ll be able to review it immediately. And if there’s a serious compliance issue, we can remove them from the program.”