The FDA finally put its mouth where the money is. During congressional hearings yesterday, CDER chief Janet WoodcockÂ said the agency would need $225 million to $250 million in additional funding to inspect foreign plants as frequently as it does in the U.S. And, along with drug compliance director Deborah Autor, Woodcock asked Congress for the power to inspect foreign companies that ship drugs to the U.S., stop imports at the border if necessary, and require U.S. drugmakers to police their foreign suppliers.
"We currently have a crisis and an opportunity to make real change," Autor said.
The requests came during hearings into the heparin-contamination scandal. The blood thinner has been linked to 81 deaths and 785 allergic reactions. In written testimony, Woodcock reiterated the FDA's suspicion that the med was deliberately tainted with oversulfated chondroitinÂ somewhere along the Chinese supply chain. Some batches of the Baxter med consisted of more than 30 percent of the contaminant, "and it does strain one's credulity to suggest that might have been done accidentally," Woodcock said.
Congressional investigator David Nelson, who's leading the heparin inquiry, criticized the FDA for failing to inspect the Chinese plant operated by Baxter's API supplier. But Nelson reserved his most pointed critique for Baxter, saying that the company hadn't adequately inspected that plant, either. For his part, Baxter CEO Robert Parkinson called import oversight problems "a global and industry-wide crisis."
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FDA's China office opens next month