In a February 18, 2014, news release, the U.S. Food and Drug Administration (FDA) announced the launch of its Secure Supply Chain Pilot Program (SSCPP) and the names of the 13 companies selected to participate in the program. The FDA originally proposed the pilot in 2009 and officially announced the start of the program and the selection criteria for participation in August 2013. The pilot is scheduled to run for two years, until February 2016.
As background, the FDA designed the program with the intent to reduce scrutiny of low-risk imports so that it may increase its attention on less trustworthy foreign-made medicine. It hopes to create incentives for manufacturers to adopt best practices for supply-chain safety so that it can enhance the quality and safety of all imported drugs. Its aim is to stop the importation of contaminated, misbranded or unapproved medications.
Under the pilot program, the 13 companies selected will receive expedited entry for up to five selected drug products imported into the United States. These drug products will be the only drug shipments allowed entry into the U.S. without human review and will be entered automatically with a “system” entry decision. In return for this expedited treatment, the drugs must be imported from the manufacturer identified on the companies’ initial pilot applications, must arrive through a designated port of entry, must use the identified customs broker or entry filer from the applications, and must be intended for the designated ultimate consignee.
The participating companies had to meet several conditions to participate, including:
- Committing to comply with the Food, Drug, and Cosmetics Act (FDCA);
- Having a validated secure supply chain protocol as a Tier II or Tier III participant in U.S. Customs and Border Protection’s (CBP) Customs-Trade Partnership Against Terrorism program;
- Having a plan in place to promptly correct potential problems identified by the FDA regarding importations of specific products;
- Having effective recall and corrective action plans in place; and
- Maintaining control over the drugs from the time of manufacture abroad through entry into the United States.
The FDA has indicated that the participating companies would have to work to stay in the program. To help determine whether participants in the SSCPP continue to meet the program’s criteria and to help evaluate the program, the FDA intends to periodically examine records and conduct random audits of shipments. If any company receives a communication from the FDA (e.g., a warning letter or untitled letter) citing violations of the FDCA relating to drug products or fails to comply with pilot requirements, the FDA will end that company’s participation.
Over the two years of the pilot program, the FDA will also evaluate the program’s effectiveness at enhancing imported drug compliance with FDA regulations and the security of the drug supply chain. If the program is effective, the FDA may establish a more permanent program and extend it to additional companies.
This is an example of how government agencies are working together to streamline the entry process for trusted importers so that the focus is on illegal or dangerous shipments of goods. In the past few years, CBP has partnered with foreign customs agencies for dual recognition of its C-TPAT program, has partnered with the Consumer Product Safety Commission to identify shipments of dangerous products, and is considering creating a trusted trader program for low-risk importers that are members of C-TPAT and its Importer Self-Assessment program.
For more information on how your company can take advantage of CBP’s programs that reward importers with strong internal compliance processes so that it may focus more on high-risk importers, please contact one of the authors listed above or any other member of Drinker Biddle‘s Customs and International Trade Team.