Urging more robust FDA response, lawmakers warn of contaminated heparin
- Five senior members of the House Energy and Commerce Committee sent a letter to FDA commissioner Robert Califf warning contaminated heparin could be circulating in the market in the US, putting the population at risk.
- The lawmakers accused the FDA of being too lenient in the face of potential contamination of Chinese heparin supply.
- Contaminated heparin, a blood-thinner, was linked to hundreds of deaths between 2007 and 2008. At the time, the tainted drugs were manufactured by Baxter International and led to severe allergic reactions. Baxter has since stopped producing the drug.
The contamination flagged by the House Commerce Committee appears to be different, however. Heparin is supposed to be derived from the intestinal membranes of pigs. China has been a top producer of crude heparin because of its abundant pig supply. However, Committee investigators concluded China does not have enough pigs to produce the amount of heparin that it is exporting to foreign markets.
The FDA's response to the Chinese heparin crisis during the end of 2007 and the beginning of 2008 had appeared comprehensive---but apparently not comprehensive enough to ward off another threat and sufficiently police Chinese suppliers.
The lawmakers highlighted five key problems, including failure of the FDA to share information from the investigation internally: lack of response to credible evidence of a threat before the crisis occurred; incomplete investigations; failure to take market conditions in China into consideration and the fact that its lengthy investigation suggests problems related to enforcing regulations against criminal economic adulteration.
The lawmakers expect a response from the FDA by April 12, 2016.