FDA Announces Beginning of Drug Secure Supply Chain Pilot; 13 Participants Selected
The Food and Drug Administration on Feb. 20 formally announced the beginning of its Secure Supply Chain Pilot for expedited entry of drug products, listing 13 companies that it approved for participation. Under the program, which began earlier this month, drug importers that meet certain requirements receive expedited entry for up to 5 specific drug products per importer. The drugs must be imported from a manufacturer identified on the importer’s initial application to participate in the pilot, and must arrive through a designated port of entry, use the identified customs broker or entry filer, and must be intended for a designated ultimate consignee. The pilot is scheduled to run until February 2016.
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FDA Selects 13 Participants; Now Past Application Deadline
In its notice of the pilot in August FDA said it would allow up to 100 companies to participate (see 13081918), but the agency has chosen only 13. In order to participate, companies must be Customs-Trade Partnership Against Terrorism (C-TPAT) Tier II or III certified, which limits pilot participants to companies in the U.S., Canada and Mexico. According to FDA, the following 13 companies have been chosen to participate:
- AbbVie Inc.
- Allergan, Inc.
- Astellas U.S. Technologies, Inc.
- Bristol-Myers Squibb Co.
- Celgene Corp.
- GE Healthcare Inc.
- GlaxoSmithKline LLC
- Merck Sharp & Dohme Corp.
- Mylan Pharmaceuticals Inc.
- Novartis Pharmaceuticals Corp.
- Pfizer, Inc.
- Teva Pharmaceutcials USA, Inc.
- Watson Laboratories, Inc.
The deadline for applications from any new companies that wish to participate passed on Dec. 31, according to FDA’s notice in August.
FDA May Create Permanent Trusted Importer Program After Two-Year Review
The main benefit to pilot participants is an automatic “system” entry decision, according to an FDA official speaking at a seminar Feb. 13. All other drug shipments must be held for review by an FDA official, and entries from pilot participants will be the only drug shipments allowed entry without human review, he said. “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 of the FDA Center for Drug Evaluation and Research in the agency’s Feb. 18 announcement. “The program also allows the FDA to focus resources on the areas with the greatest potential risk to consumers.”
Over the next two years, FDA says it will evaluate the program’s “enhancing imported drug compliance with FDA regulations and the security of the drug supply chain. If all goes smoothly and FDA decides the program is effective, a permanent secure supply chain program may be created and more companies may be allowed to participate, it said. According to the FDA official who spoke at the Feb. 13 seminar, FDA is already having difficulties with one pilot participant that may be trying to take advantage of the program, confirming some agency fears (see 14021127).