FDA pilot project ups benefits of IT supply chain investments

Almost 12 years after it began, the supply chain program Customs-Trade Partnership Against Terrorism (C-TPAT) is yet to convince everyone it is worth the effort. The benefits fall short of what some expect of a program that can require $50,000 in IT and database upgrades.

The belated arrival of an FDA supply chain pilot scheme could increase the attractiveness of the investment though. C-TPAT is supposed to streamline the process of shipping items into the U.S., but the FDA and 13 other regulatory agencies have the power to hold up the release of imports. Biopharma firms know that after spending $50,000 on IT and database improvements--which is just one part of the required investment--their imports could still be delayed by the FDA. An FDA pilot project first proposed in January 2009 could ensure these companies imports are expedited.

Companies signing up to the pilot project must show FDA they meet certain criteria, after which the regulator will speed clearance of their imports. One of the criteria is having a secure supply chain that is validated to Tier II or III of C-TPAT. This shows the FDA that a company has invested to beef up its IT and other aspects of supply chain security, making it a suitable candidate for expedited clearance. FDA is looking for 100 such companies to sign up to its pilot project. Knowing these companies meet certain standards will free up FDA resources to inspect higher-risk importers.

FDA first issued a release about the program in 2009, and followed this up last summer with a posting in the Federal Register, Regulatory Focus reports. The agency will only begin accepting applications from the middle of next month though. Assuming this process goes smoothly, FDA plans to start the two-year pilot project in February 2014.

- check out Regulatory Focus' take
- here's the FDA document (PDF)
- read a C-TPAT cost analysis

Suggested Articles

The new solution aims to streamline the incorporation of human genomic data into clinical trial designs.

TriNetX's platform uses EHR data to help drug developers with clinical trial protocol design and study site and participant identification.

The $58 million financing round represents biopharma industry's growing interest in genomics data.