House Committee Asks FDA Heparin Briefing

Bipartisan leaders of the House Energy and Commerce Committee are asking for an FDA briefing on (1) the potential threat to the U.S. heparin supply due to the outbreak of African swine fever in China and (2) any contingency plans in the event of a serious shortage.

In a 7/30 letter to FDA acting commissioner Ned Sharpless, the committee members review the facts of the African swine fever outbreak in China and its impact on the heparin supply, and note that “pharmaceutical researchers are raising concerns that the African swine fever outbreak … has the potential to cause an unprecedented shortage of heparin’s raw material.”

While there is no apparent evidence that the pig shortage in China is currently affecting the heparin supply in the U.S., the letter says, the U.S. supply is already stressed and as of 6/19, FDA added heparin to the drug shortage list