The FDA is again soliciting 100 foreign drug and API makers for a pilot program intended to help allow them to import products faster if they agree to meet certain manufacturing and supply chain standards. The idea is that if the agency has API companies it knows it can trust, it can focus more resources on those that it can't.
The agency first announced the Secure Supply Chain program more than three years ago and it was supposed to be a two-year pilot to provide it with a proof of concept that it would make available to any company that qualifies. But Regulatory Focus says the FDA recently published its intent for the program in the Federal Register saying it plans to begin taking applications soon after.
The idea for the program followed the scandal in 2008 when the FDA received reports of serious reactions, including deaths, from patients receiving dialysis. An FDA probe found oversulfated chondroitin sulfate (OSCS) in batches of heparin from Baxter International ($BAX), a major supplier to the U.S. market, and determined that the contaminant was in ingredients from China. It has taken a number of steps since then to protect against bad heparin, including banning some Chinese manufacturers and asking all approved heparinmakers to test for OSCS.
The program will allow applicants to pick up to 5 drugs 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 show that they have a secure supply chain. The ingredients must be used for FDA approved drugs and be delivered to FDA approved manufacturers.
"With the increase of drug products produced outside the United States, it is critical that the FDA concentrate its resources on companies that pose the highest risk of importing products that don't meet the FDA's standards and violate U.S. laws," a statement said when it was first announced.
- Federal Register listing
- see the FDA announcement
- read the Regulatory Focus story