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Bipartisan E&C Leaders Request FDA Briefing on Threat to U.S. Heparin Supply

Jul 30, 2019
Press Release

Energy and Commerce Committee leaders sent a letter to Food and Drug Administration (FDA) Acting Commissioner Dr. Norman E. "Ned" Sharpless requesting briefings on the potential threat to the U.S. supply of heparin, the only anticoagulant drug used for open-heart surgeries and kidney dialysis.

The bipartisan Committee leaders raise concerns over the outbreak of African swine fever in China's pig population, which endangers the source from which heparin is derived, and ask the FDA for information on any contingency plans in the event of a serious shortage of this critical drug.

The letter was signed by Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR), Oversight and Investigations Chair Diana DeGette (D-CO), Oversight and Investigations Ranking Member Brett Guthrie (R-KY), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), and Health Subcommittee Ranking Member Michael C. Burgess, M.D. (R-TX).

"U.S. dependence on Chinese heparin and on one animal source raises risks of shortages," the bipartisan Committee leaders wrote in the letter. “Pharmaceutical researchers are raising concerns that the African swine fever outbreak in China 'has the potential to cause an unprecedented shortage of heparin’s raw material.'"

While there is currently no apparent evidence yet that the pig shortage in China is impacting heparin supply in the U.S., experience from past outbreaks indicate that there may be a six to nine-month lag time before a shortage would have effects on the U.S. heparin market. The Committee leaders highlight the need to be prepared if this outbreak causes a shortage in the already-stressed U.S. heparin supply.

"As a former senior fellow for global health at the Council on Foreign Relations recently observed, 'Nearly 80 percent of the world’s heparin ingredient supply is made in China, which is why halving of the nation’s swine population should also be a major pharmaceutical concern for the world,'" the bipartisan Committee leaders continued. "In advance of this potential supply problem, please have appropriate FDA staff provide a briefing to Committee staff on how the agency is monitoring the adequacy of the U.S. heparin supply, and on FDA’s plans to address a potential shortage and threat of economically-motivated adulteration."

To read the full letter, click here.