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Secure Supply Chain Pilot Program for Imported Drugs Gets Underway

Friday, February 21, 2014
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration announced Feb. 18 the initiation of the Secure Supply Chain Pilot Program to strengthen controls on imports of drug products. The 13 companies designated to participate will receive expedited entry for imports of up to five selected drug products. The FDA states that the goal of this program is to allow the agency to focus its import 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 pilot program will run for two years, during which time the FDA will evaluate its effectiveness at enhancing imported drug compliance with FDA regulations and the security of the drug supply chain. The FDA has previously said that this evaluation will be based on several factors, including timeframes for the passage of drugs through the import entry process and the level of adherence by program participants to program criteria. If the FDA determines the program to be effective, a more permanent program may be established and possibly extended to additional companies.

The companies accepted into the program are 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. and Watson Laboratories Inc.

According to the FDA, each of these companies has committed to comply with requirements of the Federal Food, Drug and Cosmetics Act; has a validated secure supply chain protocol per the Customs-Trade Partnership Against Terrorism; has a plan in place to quickly correct potential problems the FDA identifies regarding importation of specific products; has effective recall and corrective action plans in place; and maintains control over its drugs from the time of manufacture abroad through entry into the United States.

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