Heparin flowing into the U.S. from China has been a very sensitive subject since tainted supplies were tied to about 150 deaths here 5 years ago. The U.S. has banned some Chinese manufacturers and warned drugmakers who use heparin to make sure their supplies meet FDA expectations. But now Smithfield Foods' $4.7 billion deal to sell itself to China's Shuanghui International has run up a red flag among lawmakers about heparin flowing in the other direction.
Not surprisingly, as the world's largest pork producer, Smithfield also is a major supplier of crude heparin to the pharma industry, according to Reuters. Republican members of the U.S. House Committee on Energy and Commerce have sent a letter to Smithfield CEO Larry Pope asking the company to delineate how much crude heparin it supplies to pharma so they can judge the potential impact.
"The Committee's investigation indicates that the U.S. heparin supply is stressed, and could well be in shortage," the lawmakers' letter said. "China's heparin market is experiencing its own pressures, and Smithfield Foods under Shuanghui control may be pressured to export its crude heparin product to China instead of supplying U.S. companies." A Smithfield spokesperson said the company will give the congressmen what they asked for, while the FDA declined to make any comment on what it thinks of the situation.
Sensitivities about China and crude heparin surfaced in 2008 when the FDA received reports of serious reactions, including deaths, from patients receiving dialysis. An FDA probe found oversulfated chondroitin sulfate (OSCS) in batches of heparin from Baxter International ($BAX), a major supplier to the U.S. market, and determined that the contaminant was in ingredients from China. The agency found that Chinese suppliers intentionally used OSCS because it was cheaper. "OSCS contamination of heparin appears to be an example of intentional adulteration, and has also been referred to as economically motivated adulteration," the agency said last year. Since then, the FDA has banned supplies from 22 Chinese companies.
The proposed buyout has already raised lots of concerns about food safety and supplies. According to Reuters, the letter from the Congressmen said the government has decided to take an additional 45 days to figure out all the implications of this deal for the U.S.
- read the Reuters story