The goal of the program, according to an agency statement, is to enable the FDA 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."
“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.
The prequalified companies accepted into the program that will receive expedited entry, are the following:
· Astellas U.S. Technologies
· Bristol-Myers Squibb
· GE Healthcare
· Merck Sharp & Dohme
· Mylan Pharmaceuticals
· Teva Pharmaceutcials USA
· Watson Laboratories
The prequalified companies will receive expedited entry for the importation of as many as five selected drug products into the U.S. 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 U.S.