FDA Implements Pilot Program For Fast-Track Drug ImportationBy: Sean Patterson - February 18, 2014
The U.S. Food and Drug Administration (FDA) today announced that it has begun its two-year Secure Supply Chain Pilot Program. The program is meant to streamline some drug importation for select companies so that the FDA can focus its resources on more high-risk illegal importation. Following the two-year program the FDA will evaluate its success and possibly make it permanent, expanding it to other companies.
Thirteen drug companies have been selected to participate in the trail program. The list reads as a rundown of the largest pharmaceutical companies based in the U.S. including Bristol-Myers Squibb, AbbVie, Allergan, GE Healthcare, Celgene, Astellas U.S. Technologies, GlaxoSmithKline, Mylan, Novartis, Pfizer, Teva, Watson Laboratories, and Merck Sharp & Dohme.
Each of these companies will have to comply with a set of rules established by the FDA to get their expedited importation. These rules include a strict adherence to the Food, Drug, and Cosmetics Act; a secure supply chain protocol validated by U.S. Customs, and plans to correct problems or issue recalls in the event of mishaps. The companies will be required to have control over their drug imports through their complete distribution chain, from manufacture to entry into the U.S.
“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 Center for Drug Evaluation and Research’s Office of Compliance at the FDA. “The program also allows the FDA to focus resources on the areas with the greatest potential risk to consumers.”