U.S. and Chinese regulators still haven't wrapped up their detective work in the 2008 heparin snafu, a congressional committee says, and they need to get cracking. It's now three years after Baxter's tainted blood thinner was recalled, but the FDA hasn't identified the people responsible for the contamination, and so the House Energy and Commerce Committee is demanding records of the investigation.
The FDA and its Chinese counterpart traced the heparin contamination to tainted raw ingredients sourced in China. But the raw material for heparin is produced in a wide array of small facilities around that country. Tracking the problem further required close cooperation between the FDA and Chinese regulators, and officials in China appeared less than cooperative.
But the FDA's failure to find the ultimate source poses a present-day risk, Republican Fred Upton said in the committee's letter to FDA. "There is reason to believe all or some of the individuals responsible for the adulteration are still actively engaged in the Chinese pharmaceutical supply chain and pose a continuing threat to pharmaceutical products imported to the (United States)," Upton and his colleagues wrote.
The FDA told Reuters it's working on a response to the letter.