Chinese RU-486 maker sold tainted drugs

Can we trust a Chinese manufacturer that not only sold contaminated cancer drugs but tried to cover up the fact? Apparently, the FDA thinks so. Shanghai Hualian is the sole U.S. supplier of mifepristone (RU-486), the abortion pill. It's also the company under criminal investigation in China for selling tainted leukemia drugs. And the FDA simply won't say whether the company exports any other drugs or pharma ingredients to the U.S.

The mifepristone is made in an entirely different plant run by the company, yes. And--unlike a host of long-uninspected foreign facilities--the FDA inspected this one as recently as May. It passed. China's FDA also has given the plant three look-sees in the last few months and proclaimed it clean. But Chinese regulators also have accused the company of a systematic cover-up of violations at the cancer drug facility.

At least one American drug maker--Pfizer--refuses to buy drug ingredients from Shanghai Pharmaceutical Group because of quality problems. Consumer advocates say Shanghai's problems demand additional scrutiny. "Every one of these plants should be immediately inspected," one told the New York Times.

- read the New York Times article

Suggested Articles

Post-Tesaro buyout, don’t expect GlaxoSmithKline to spring for more commercial-stage oncology products anytime soon.

Already a fast-growing blockbuster, Novo Nordisk's injectable Ozempic won a major heart-helping FDA nod that could bode well for its oral sibling.

Bayer's new Vitrakvi for tumors with NTRK gene fusions is meeting skepticism in England and Germany, where cost watchdogs on Friday rejected it.