US House Committee Raises Concerns to FDA Over Heparin Supply
The US House of Representatives’ House Energy and Commerce (E&C) Committee has sent a letter to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb asking the agency to review and respond to inconsistent data on the US supply of heparin, an anticoagulant. The E&C Commiitte is asking the FDA to review the US supply of Chinese heparin as to whether it is increasing or decreasing and provide a contingency response plan in the event of a heparin shortage by March 2, 2018.
In the letter, the committee expressed concern on three issues: (1) whether the Chinese heparin supply is shrinking or increasing, which could affect the risks of a heparin shortage in the US and possibly raise economically motivated adulteration of the drug; (2) whether Chinese customs data accurately reflect Chinese heparin export and import activity; and (3) whether the recent emergence of significant US heparin imports to China is further constraining the US domestic supply of heparin.
The E&C Committee’s investigation into the contamination of crude heparin manufactured in China began a decade ago after contaminated heparin reached the US heparin supply in late 2007 and early 2008. “Although the perpetrators have not been identified, test results and other evidence point to the contamination occurring upstream in the Chinese heparin supply chain,” said the letter.
Heparin is a drug derived from pig intestines. Although heparin can also be derived from other animal sources, for more than 20 years, the US and many other countries have adhered to a porcine origin requirement because of concerns over bovine spongiform encephalopathy, commonly known as mad cow disease. About 60% of the crude heparin used to manufacture finished heparin in the US is sourced from China, according to information in the letter.
The Congressmen also expressed concern that the demand of heparin is increasing. “While the Chinese heparin supply has increased since the heparin crisis of 2008, global heparin API [active pharmaceutical ingredient] demand has nearly doubled during the same time frame, from 23.6 trillion units of heparin to an estimated 44.3 trillion in units in 2015,” the Congressmen said in the letter.
The Congressmen raised the point that China has recently imported greater quantities of heparin, which includes heparin from the US. “In 2016, the US exported 17,050 kilograms of heparin to China, by far the leading exporter of heparin that did not originate in China and with the greatest value of imports at $11,634,209,” the letter said.
In the letter, the E&C Committee asked the FDA to review the US supply of Chinese heparin as to whether it is increasing or decreasing and provide a contingency response plan in the event of a heparin shortage by March 2, 2018.
