FDA program would allow inspectors to focus on trouble spots

The way the FDA sees it, the agency could inspect companies and facilities a lot more efficiently if it could concentrate on those that pose the highest risk. With that in mind, the agency is finally seeking 100 volunteers for its Secure Supply Chain Pilot Program (SSCPP), which would allow them an easier path for product deliveries if they agree to certain standards.

"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," a Federal Register notice says.

The agency first discussed the program in 2009, a year after tainted heparin was implicated in the deaths of dozens of U.S. patients. But a lot has happened since then. The number of drugs and APIs produced outside the U.S. has exploded, and the FDA has been expanding its foreign inspection staff in an effort to keep up. In its budget "justification" document for next year, the agency said inspections of foreign manufacturers jumped 10% last year to 813 inspections in 62 countries. The agency said nearly half of the 46 warning letters issued to foreign manufacturers resulted from inspections by its global staff.

A year ago the FDA said it expected to launch the program soon, but the Federal Register notice seeking applicants was only published today. The program will allow applicants to pick up to 5 products, finished drugs or APIs, for inclusion. Only FDA-approved manufacturers are eligible, and to qualify they must show that they will maintain control of the products from manufacture to delivery to the U.S. and  that they have a secure supply chain. The ingredients must be used for FDA-approved drugs and be delivered to FDA-approved manufacturers. In exchange, the FDA says those companies can expect their products to get into the U.S. faster.

This is not the only FDA effort to gain more oversight of the ever-expanding manufacturing universe. It is also collaborating with other regulatory agencies around the world on inspections of plants in other countries.

- access the Federal Register notice here
- and the FDA's 2009 announcement