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Regulatory Focus™ > News Articles > 2019 > 7 > House Committee Seeks FDA Briefing on Heparin Supply

House Committee Seeks FDA Briefing on Heparin Supply

Posted 30 July 2019 | By Zachary Brennan 

House Committee Seeks FDA Briefing on Heparin Supply

The House Energy & Commerce (E&C) Committee leaders sent a letter on Tuesday to US Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless seeking further information on how FDA is monitoring the supply of the anticoagulant heparin.

The letter notes how the US is reliant on China for its supply heparin, which in turn is reliant on China’s pig supply. Recently, China struggled to contain an outbreak of African swine fever and will lose about 150 million of its approximately 440 million pigs.

“Currently, there is no apparent evidence yet that the pig shortage in China is impacting the heparin supply in the United States,” Reps. Frank Pallone (D-NJ), Anna Eshoo (D-CA), Diana DeGette (D-CO), Greg Walden (R-OR), Michael Burgess (R-TX) and Brett Guthrie (R-KY) wrote. “However, the US heparin supply is already stressed. As of June 19, 2019, FDA added heparin to the drug shortage list, and in recent years there have been periodic heparin shortages.”

As a 2006 outbreak of Blue Ear Virus showed, there may be a six- to nine-month lag before a shortage would be seen in the US, they added.

“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 US heparin supply, and on FDA’s plans to address a potential shortage and threat of economically-motivated adulteration,” the representatives wrote.

The E&C committee last February raised similar concerns on the US reliance on China to manufacture heparin. And previously, in 2007 and 2008, adulterated heparin sourced from China led to the deaths of more than 100 Americans and prompted an investigation by FDA that led to dozens of Chinese heparin suppliers being placed on import alert.

E&C Letter


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Tags: China, heparin, swine