Congress asks FDA for plan to address potential major heparin shortage

Aug. 2 (UPI) -- Congress wants to know what contingencies are in place if the outbreak of African swine fever in China wipes out the supply of heparin, a critically important anticoagulant drug derived from pigs.

Members of the House Committee on Energy and Commerce sent a letter to the Food and Drug Administration on Wednesday, asking for details about how the agency is "monitoring the adequacy of the [United States'] heparin supply" and about "FDA's plans to address a potential shortage."

Heparin is the only anticoagulant drug used in the United States for open-heart surgery and kidney dialysis. It also is used to help deliver an antidote for overdoses, among many other treatments, the letter noted.

Because China has more than half the pigs on the planet, the majority of the heparin produced worldwide comes from that country. However, African swine fever is killing China's pigs at record speed. As much as 40 percent of the herd might be gone, commodities experts said.

The committee, chaired by U.S. Rep. Frank Pallone Jr., D-N.J., also raised concerns over unapproved and potentially dangerous "adulterations" to the anticoagulant drug that companies might produce should heparin supplies become scarce.

"Heparin is a drug derived from pig intestines," the letter said. "The United States is largely dependent on China for its heparin because almost half of the global pig supply is in China. About 60 percent of the crude heparin used to manufacture finished heparin in the United States is sourced from China."

Researchers estimate that roughly 80 percent of crude heparin available globally is produced in China.

In response to the letter, the FDA said it "has been monitoring this issue since last year and has followed up with heparin suppliers. At this time we do not anticipate supply issues."

However, at least one drug company that manufactures heparin has issued a warning that heparin supplies might be in peril.

"The potential shortage stems from supply interruptions at other finished-dose manufacturers, as well as an outbreak of [African] swine fever in China, which is a major global supplier of the active pharmaceutical ingredient (API) in Heparin," the company Fresenius Kabi said in a letter to customers July 9.

"The situation in China is expected to cause API supply constraints globally for an unknown period," the letter said. "This has significantly increased demand for Fresenius Kabi heparin."

The FDA and the American Society of Health-Systems Pharmacists, which maintain separate databases of drug shortages, have listed a heparin shortage since 2017.

Researchers in Brazil first raised concerns about African swine fever's threat to global heparin supplies in January.

China was producing 440 million of the world's 770 million pigs before the deadly African swine fever virus outbreak began last fall. It's difficult to accurately track the extent of the outbreak, but many analysts around the world estimate that China has lost between 30 and 40 percent of its pigs -- and counting.

Those same analysts say it will take years for China to contain the virus.

"If [African swine fever] becomes an epidemic in China, the worldwide supply chain of heparin products should face the worst shortage registered thus far," Paulo Mourao, a medical biochemistry researcher at the Federal University of Rio de Janeiro, told UPI in April. Mourao in January co-authored a study that predicted a global heparin shortage.

At that time, China had reported culling about 1 million pigs, and experts predicted losses would reach 25 percent by the end of the year. Current losses have likely surpassed that estimate.

"Halving of [China's] swine population should also be a major pharmaceutical concern for the world," the congressional letter said.