FDA: We’re Not Withholding Information From Congress

-FDA News

05/14/2008 -  Contrary to recent press reports, the FDA is not withholding from Congress the names of 12 China-based companies implicated in distributing contaminated batches of heparin, the agency said.

“Don’t believe everything you see in The Wall Street Journal,” the FDA said. “We haven’t refused to give names to Congress. We are still working on getting the list to Congress.”

Staff from the House Oversight and Investigations Subcommittee confirmed that the FDA has not refused to provide the information.

During a hearing of the subcommittee in late April, CDER Director Janet Woodcock told House Energy and Commerce Committee Chairman John Dingell (D-Mich.) that the agency had traced the heparin contaminant to 12 different Chinese companies and that tainted heparin was shipped to 11 countries. When Dingell asked if the FDA would provide the names of the 12 Chinese firms, Woodcock said it would.

The problems with heparin have sparked renewed calls from Congress to beef up the FDA’s foreign inspections program. Woodcock has said the program is weak. Legislation to require drug manufacturing-plant registration fees to fund FDA inspections is circulating in Congress.

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