FDA's Secure Supply Chain Pilot Program (SSCPP) is up and running

FDA has announced that 13 companies have agreed to participate in a pilot program 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.” That’s the enforcement side of the potential benefit; for qualified manufacturers, the operational benefit will be expedited clearance through customs.

SSCP originated in a 2009 proposal to evaluate supply-chain security measures by FDA, and was further clarified by a clause of the FDA Safety and Innovation Act of 2012 that enables FDA to take a more risk-based approach to import clearances. As planned, the two-year pilot program will allow prequalified importers (who have to be licensees of FDA-approved products), having filed the necessary applications and shipment paperwork, to pass more smoothly through Customs and FDA clearances (the precise time savings haven’t been specified). FDA will be monitoring how well importers are able to maintain correct procedures and filings, as well as overall efficiencies of having the program in place.

The 13 companies 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 Pharmaceutcials USA, Inc.

• Watson Laboratories, Inc.

C-TPAT prerequisite

SSCPP follows some of the same logic as the Customs-Trade Partnership Against Terrorism (C-TPAT), which arose in the aftermath of the 9/11 attack and the requirements to examine imports prior to clearance. To minimize a import gridlock, US Customs and the Transportation Security Agency established C-TPAT, allowing shipments that had been inspected by an authorized person and kept secure until transit to pass through Customs (non-C-TPAT shipments are supposed to be opened and inspected prior to clearance). Besides membership in C-TPAT, SSCPP participants must maintain control of their shipments from point of manufacture to entry to the US. Many pharma manufacturers, and most of the 3PL logistics providers serving the industry, are C-TPAT members.

Tony Barone, a Pfizer supply-chain executive, addressed SSCPP at the recent meeting of the Pharmaceutical Cargo Security Coalition. The genesis of the effort began when Pfizer and other companies saw shipments coming into the US being held up for arbitrary reasons, with the complication that a next shipment couldn’t be cleared until the first one had. As the volume of imported drugs has grown, the problems of just managing routine deliveries mounted, and manufacturers sought relief from FDA.

At the end of the two-year pilot—or sooner if the program runs into problems—FDA will make a determination to expand the program, kill it or continue the pilot.