FDA: US Heparin Supply Not Impacted by African Swine Fever in China

Regulatory NewsRegulatory News
| 07 October 2019 | By Zachary Brennan 

With shortage concerns looming, the US Food and Drug Administration (FDA) on Monday said that the US heparin supply is not being impacted by the African swine fever in China.

“The majority of manufacturers reported no such issues related to African swine fever,” FDA said after reaching out to heparin suppliers. “FDA continues to be in regular contact with US heparin suppliers and manufacturers as this situation evolves.”

The update from FDA follows a letter sent in late July by the House Energy & Commerce Committee to FDA Acting Commissioner Ned Sharpless seeking further information on how FDA is monitoring the supply.

The letter noted 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.

According to the American Society of Health-System Pharmacists (ASHP), several manufacturers have said they are experiencing shortages of heparin. For instance, ASHP said Fresenius Kabi has put heparin “on a protective allocation due to a potential shortage of raw ingredient,” while “Pfizer has heparin on shortage due to manufacturing delays.” And manufacturer Sagent “has heparin on shortage due to manufacturing issues and increased demand.” But other manufacturers have said they have supplies of the critical drug.

The shortages and questions on China-based manufacturers follows previous issues with Chinese heparin manufacturers that led to the deaths of nearly 150 Americans in 2008.


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