US FDA Seeks Applicants to Test Supply Chain Security for Drugs, APIs

19-Aug-2013 - Last updated on 20-Aug-2013 at 08:07 GMT

Related tags Supply chain Pharmaceutical drug Pharmacology Fda

The two-year pilot project will help the US Food and Drug Administration further assess the growing number of companies and countries involved in importing drugs to the US.

The SSCPP (Secure Supply Chain Pilot Program) will help the agency better root out adulterated, misbranded or unapproved drugs by allowing the nearly 100 finished drug companies and API (active pharmaceutical ingredient) producers who qualify for the pilot to have their products expedited for entry to the US.

The FDA first launched the idea of the pilot project back in 2009 and revised it in 2012 to better meet the needs of potential applicants. Companies can apply to participate in the SSCPP (Secure Supply Chain Pilot Program) from Sept. 15 through Dec. 31.

The pilot will run from Feb. 2014 through 2016 and applicants will have to meet specific criteria laid out by the agency. The applicants will be relatively small in size since the FDA stipulates that participants cannot have more than five drug products.

“Such a program would increase the likelihood of expedited entry for specific finished drug products and active pharmaceutical ingredients (APIs) imported into the United States that meet the criteria for selection under the program,” the FDA said in a notice published Tuesday.

The agency also plans to evaluate the SSCPP based on the timeframes for passage of drugs through the import entry process, the level of adherence by the program participants and the impact of the SSCPP.

Background

Securing the US supply chain has been on the minds of the FDA recently. FDA commissioner Margaret Hamburg said at a conference last month, “Nearly 40% of the drugs that Americans take are made elsewhere. And 80% of the sites that manufacture active pharmaceutical ingredients… And in addition to the just the sheer volume of imports in foreign facilities, there‘s been an increase in the variety of sources, shippers, methods of transportation of imported products, distributors, and all of this adds to the complexity of supply chain that brings these products to us.”

The agency also proposed a rule in late July that would allow its inspectors to detain adulterated or misbranded drugs. Draft guidance on circumstances when manufacturers can delay, deny or refuse an inspection was also recently released.