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Amidst Fraud Concerns in China, E&C Leaders Ask FDA for Contingency Plan for U.S. Heparin Shortage

FOR IMMEDIATE RELEASE
February 2, 2018
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Amidst Fraud Concerns in China, E&C Leaders Ask FDA for Contingency Plan for U.S. Heparin Shortage

Chinese Manufacturer’s Refusal to Accept China Customs Data and FDA’s Discovery of Industry Use of Frozen Intestines Point to Integrity Issues

 

WASHINGTON, DC – Energy and Commerce Committee leaders today sent a letter to the U.S. Food and Drug Administration (FDA) sharing new information and concerns regarding China’s market for heparin, an essential medicine used in open heart surgeries and kidney dialysis.

Among the concerns reported are the public dismissal by a Chinese heparin manufacturer of Chinese customs data that showed questionable surging exports to Thailand and Hong Kong, and the discovery of Chinese industry use of frozen pig intestines to make heparin, suggestive of internal supply pressures in China that raises risks of fraud and adulteration. Given the United States’ reliance on China for the drug, an anticoagulant used to decrease blood clotting, leaders also requested a contingency plan in the event of a heparin shortage. The FDA recently added heparin to its list of drug shortages.

The letter was signed by Energy and Commerce Committee Chairman Greg Walden (R-OR), Energy and Commerce Committee Vice Chairman Joe Barton (R-TX), Health Subcommittee Chairman Michael C. Burgess, M.D. (R-TX), and Oversight and Investigations Subcommittee Chairman Gregg Harper (R-MS).

The committee has a long history monitoring the Chinese heparin market, beginning a decade ago after contaminated Chinese heparin arrived in the U.S. and harmed American patients. The contamination was believed to be linked to shortages in the pig supply caused by a disease outbreak. U.S heparin is required to be derived only from pig intestines. However, shortage concerns led FDA to propose the reintroduction of bovine-sourced heparin in 2014.

About 60 percent of the crude ingredients used to manufacture heparin in the U.S. are sourced from China, leaving the U.S. health care system vulnerable to fluctuations in its supply. Because it could take years for the U.S. to reintroduce bovine-sourced heparin manufacturing, the U.S. is expected to heavily rely on China for heparin in the near-term. As a result, lawmakers flagged concerns regarding the true capacity of the Chinese-sourced heparin market, recent fluctuations in China’s export of heparin, and the volume of heparin the United States exports to China – despite its own reliance on the Chinese market.

“We write today to forward information for FDA’s further review and action, as appropriate, related to inconsistencies and red flags in Chinese heparin export and import data that could impact the U.S. heparin supply,” wrote Walden, Barton, Burgess, and Harper. “The areas of concern relate to the following: (1) whether the Chinese heparin supply is in fact shrinking or increasing, which could affect the risks of a heparin shortage in the U.S. and could raise the risk of economically-motivated adulteration; (2) whether Chinese customs data accurately reflect Chinese heparin export and import activity; and (3) whether the recent emergence of significant U.S. heparin imports to China is further constraining the U.S. domestic supply of heparin.”

Despite the United States’ reliance on China’s heparin supply, the U.S. is also curiously the largest exporter of the drug to China. The committee leaders touched on the interesting dynamic between the two countries’ imports and exports of heparin, noting the recent growth of U.S. exports to China.

“Between 2007 and 2013, the U.S. either had zero exports or exports to China in the single digits. In 2014, the U.S. exported 2,003 kilograms of heparin to China, and in 2015, the U.S. exported 2,822 kilograms of heparin to China,” committee leaders wrote. “In 2016, the U.S. exported 17,050 kilograms of heparin to China, by the far the leading exporter of heparin that did not originate in China and with the greatest value of imports at $11,634,209.”

The leaders noted that there also appears to be strange trends in the Chinese supply of heparin – exports to Thailand and Hong Kong have skyrocketed from no exports a decade ago to more than 40,000 kilograms and 28,000 kilograms exported respectively in 2016.
Click HERE to read a copy of the letter.

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