FDA To Pilot Secure Supply Chain Program

Last week the FDA announced it would select candidates to participate in its Secure Supply Chain pilot. The program is designed to protect pharmaceuticals and their ingredients that are produced outside of the US. The incentive for pharmaceutical companies is that the FDA has indicated that it will expedite the entry of products meeting the pilot's criteria into the US. Those outside the pilots criteria will no doubt be subject to increased FDA scrutiny.

The goal of the pilot is to create a secure supply chain that will help mitigate risks, such as contamination and counterfeiting. In the past the FDA has come under extreme pressure with respect to drug contamination due to imported ingredients. In March 2008 the FDA found contamination in an imported ingredients from China that were used to manufacture the blood thinner Heparin, marketed by Baxter Healthcare. According to the New York Times, the tainted Heparin caused 81 deaths in the US from Heparin manufactured by as many as 12 companies in China.

As well as launching the Secure Supply Chain program, the FDA has opened offices in India and China. This is an initial attempt to try to help in the monitoring of the increasing numbers of pharmaceutical manufacturers in those countries. Last year a government report stated that the FDA would need $56 million to begin full inspections of foreign plants and $15 million annually to inspect China’s drug plants every two years, which is the standard in the US.