On the one hand, we have Health and Human Services Secretary Mike Leavitt gladhanding Chinese officials as he announced the heparin supply is now safe--including the crude heparin coming from China's workshops. On the other, there's Rep. Bart Stupak (photo), whose congressional committee is investigating the heparin debacle, contending that, "The FDA thinks they have it under control, but they really don't. If I was the FDA director, I'd shut down every drug coming in from China" until they were deemed safe, he told the Wall Street Journal.
Stupak is riled because the FDA won't hand over the names of Chinese heparin suppliers, citing confidentiality agreements. He and his committee worry that Chinese companies aren't fully cooperating with the agency's probe; during recent testimony, an FDA inspector said Chinese manufacturers didn't give them complete access to suppliers of crude heparin. Of course, Chinese officials accused Baxter of stonewalling their investigation, too.
All of which shows that politics is clouding the process of tracing contaminated heparin back to its source or sources--politics that go way beyond the typical Democrats-versus-Republicans grandstanding in our nation's capitol. Because this investigation crosses international boundaries, inspectors are hamstrung by deals higher-ups made on their behalf. As the top brass are smiling and making promises, the on-the-ground investigators are fighting red tape. Yet another unforeseen consequence of the globalization of pharma.
- read the article in the Wall Street Journal
- see Leavitt's pronouncement
- check out the UPI story
ALSO: The FDA sent out a new round of alerts to hospitals, pharma groups, and medical societies after learning that some medical facilities still had contaminated heparin among their supplies. Report
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