FDA: Secure Supply Chain Pilot Program

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The FDA initiates the Secure Supply Chain Pilot Program to enhance the security of imported drugs. So far thirteen prequalified companies have been accepted for participation and will receive expedited entry for the importation of up to five selected drug products into the United States.
According to the press announcement of the FDA 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 U.S. drug supply.
The prequalified companies accepted into the program that will receive expedited entry, are the following:
AbbVie Inc.
Allergan, Inc.
Astellas U.S. Technologies, Inc.
Bristol-Myers Squibb Company
Celgene Corporation
GE Healthcare Inc.
GlaxoSmithKline LLC
Merck Sharp & Dohme Corporation
Mylan Pharmaceuticals Inc.
Novartis Pharmaceuticals Corporation
Pfizer, Inc.
Teva Pharmaceuticals USA, Inc.
Watson Laboratories, Inc.
The participating companies met multiple participation conditions, e.g, having a validated secure supply chain protocol or having effective recall and corrective action plans in place. Additionally, the companies have to maintain control over their drugs from the time of manufacture abroad through the entry into the United States.
During the next two years, the FDA will evaluate the program’s effectiveness. If it shows to be effective, a more permanent program may be established and possibly extended to additional participating companies.

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