FDA Gives Some Drugmakers Expedited Import Entry Review

The Food and Drug Administration (FDA) has launched the Secure Supply Chain Pilot Program. The pilot program, running from February 2014 through February 2016, allows approved companies to receive expedited import review. Because many drugs are made overseas, the FDA finds it difficult to regulate the global supply chain. Therefore, by pre-approving imports from companies that have a good track record, the FDA can focus on those that do not. The effort protects the public from counterfeit drugs, dangerous formulations, or poor quality medications. The program is jointly managed by the Office of Regulatory Affairs (ORA) and the Center for Drug Evaluation and Research (CDER).

The FDA’s goal is to focus its resources most effectively. Its import surveillance resources are limited, so stopping high-risk drugs from entering the country advances the federal agency’s mission of protecting the safety and quality of the U.S. drug supply. Carol Bennett, acting director of the Office of Compliance in the FDA’s CDER said, “By creating incentives for manufacturers to adopt best practices for supply chain integrity, we can enhance the quality and safety of imported drugs. The program also allows the FDA to focus resources on the areas with the greatest potential risk to consumers.”

Secure Supply Chain Pilot Program

The Secure Supply Chain Pilot Program is open to qualified applicants on a voluntary basis. Interested companies can fill out an application and have up to five drugs designated for expedited import entry review. Prospective firms must be the drug sponsor or the foreign manufacturer of the ingredient or finished drug product. Companies must meet GMP practices and adhere to the Federal Food, Drug and Cosmetic Act, sections 510(i) and 510(j). Firms must also participate in the Customs-Trade Partnership Against Terrorism (C-TPAT). Accepted companies should have plans in place to respond to FDA concerns and have plans to issue recalls, if necessary. 

The FDA began accepting applications on September 16, 2013. Thirteen firms are approved so far.

• 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 Pharmaceutcials USA, Inc.
• Watson Laboratories, Inc.