US Congress considers action over heparin fiasco

The US Congress is set to examine options for changes to the law, following the fiasco involving the Food and Drug Administration's failure to inspect the correct production site for a pharmaceutical ingredient (Marketletter February 25). The Changzhou SLP site in China, which the country's State Food and Drug Administration states is not licensed to produce human pharmaceutical products, has been supplying US firm Baxter Healthcare with a raw material from pigs for the blood thinner heparin. With over 350 adverse reactions now reported, including four fatalities in the USA, the fact that the FDA first claimed to have never inspected the site, then to have visited the wrong location, has done nothing to allay previously-raised concerns about the US agency's oversight capacity.

According to a report in the Wall Street Journal, it has yet to be determined what caused the allergic reaction to heparin, which has been withdrawn from circulation by Baxter.