House committee seeks pharma input on heparin probe

US legislators are expanding their investigation into the adulterated heparin scandal by asking 10 pharmaceutical companies to divulge their own experiences with the heparin supply chain in China.

The House Energy and Commerce Committee re-launched its investigation into the scandal earlier this year, citing "substantial public interest" in solving the case because so much of the heparin used in the USA today is still sourced from China.

Companies including Baxter and B Braun Medical were forced to recall heparin products containing China-sourced active ingredient contaminated with oversulphated chondroitin sulphate (OSCS) after more than 80 deaths were seen in US patients.

Now, committee chair Fred Upton and fellow panel members have contacted Sanofi, Sandoz, APP Pharmaceuticals, Amphastar, Momenta, Siegfried USA, Sagent Pharmaceutical, Drug Source Company, Global Pharma Sourcing and Pacific Rainbow International to try to enlist their aid in solving the riddle of how the OSCS-laced API entered the supply chain.

"There is reason to believe all or some of the individuals responsible for the adulteration are still actively engaged in the Chinese pharmaceutical supply chain and pose a continuing threat to pharmaceutical products imported to the US," say Upton and colleagues.

Letters addressed to the 10 drugmakers - one of which can be viewed here -  ask for documents relevant to heparin-related firms in China, heparin adulteration incidents in and outside the USA, and information on oversulphated glycoaminoglycans.

The letter sets a deadline of July 29 for responses, and asks for documents dating back to 2006.

The committee estimates that China is the source for around 80 per cent of all heparin used in the USA and 16 per cent of all active pharmaceutical ingredients (APIs) found in US medicines.

"It is important to determine how the adulteration happened so that industry and government can take more effective proactive measures to reduce the risk of such adulteration in future," they write.