FDA initiates the Secure Supply Chain Pilot Program to enhance security of imported drugs

The US Food and Drug Administration is initiating a Secure Supply Chain Pilot Program to enhance the security of imported drugs.

In August 2013, the FDA invited companies to submit applications for participation in this two-year program. Some 13 prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the USA. These companies involved are AbbVie, Allergan, Astellas, Bristol-Myers Squibb, Celgene, GE Healthcare, GlaxoSmithKline, Merck Sharp & Dohme (Merck & Co), Mylan, Novartis, Pfizer, Teva and Watson Laboratories.

The goal of the program 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 US drug supply.