Democrats, FDA Official at
Odds Over Inspection Plan
By ALICIA MUNDY
May 2, 2008; Page A4
WASHINGTON -- A top Food and Drug Administration official rebuffed calls by congressional Democrats to support their proposals for tougher regulations on imported drugs and new fees on drug makers, in the latest round of conflict between lawmakers and the administration over drug safety.
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, backed away from comments this week in which she seemed to acknowledge that the FDA needed an additional $225 million to beef up foreign inspections. Democrats on Thursday thanked her repeatedly for that earlier statement, which they have seized on as ammunition in support of their legislation.
But Dr. Woodcock refused to specify under questioning Thursday how much the FDA needs to inspect foreign drug facilities properly. She said the agency needs more resources for improved technology to track and trace foreign drugs but added that the administration must evaluate exactly how much money is needed.
A group of Democratic lawmakers led by House Energy and Commerce Committee Chairman John Dingell (D., Mich.) has proposed raising hundreds of millions more to finance broader drug and medical-device inspections through fees to be levied on drug and medical-device makers.
The proposal, called the "FDA Globalization Act," has drawn fire from some drug makers, as well as congressional Republicans. Mr. Dingell and his co-sponsors have been pushing the bill following a scandal over deaths linked to contaminated heparin, a widely used blood thinner, that was derived from Chinese raw materials.
Thursday, Democrats prodded Dr. Woodcock to say that their proposal would help the agency by generating hundreds of millions of dollars for more overseas inspections. Dr. Woodcock said she hadn't been given the chance on Tuesday to explain her comments.
Dr. Woodcock then raised concerns with one of the key parts of the bill that would make the FDA inspect foreign manufacturers every two years, as it does domestic drug makers. "Any legislation should allow the FDA to set its priorities based on risk assessment," she said, explaining that FDA might find it a costly burden to automatically schedule foreign inspections for plants every two years. She prefers that the agency make inspection decisions based on a company's performance and other factors.
She was also hesitant to embrace proposed registration user fees for drug or device makers. Dr. Woodcock said the agency was still evaluating the bill's proposals on new fees.
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