Now you see it, now you don't. Congress thought--or pretended to think, you never know on Capitol Hill--that the FDA had ball-parked the funding it needs to beef up foreign inspections. That would be $225 million, a number contributed by CDER chief Janet Woodcock on Wednesday. But Thursday at a hearing of the House Energy and Commerce Committee, Woodcock backed away from that figure, saying that the agency does need more resources, but the Bush administration had to say how much.
Woodcock also declined to support the lawmakers' proposed legislation, which would boost inspections and enforcement powers in an attempt to prevent contaminated drugs from slipping into the U.S. Mandating foreign facility inspections every two years isn't a good idea, she added, saying that the FDA should decide which plants to check out, based on risk assessment.
Neither would Woodcock support user fees as a funding mechanism for inspections. But industry types who testified at the same hearing said they're open to those fees--within limits. And the industry wants assurances that inspections will focus on "high-risk" foreign manufacturers.
Consumer advocates are also OK with user fees, but also within limits. Drugmakers shouldn't use the fees as a way to "exert undue influence over FDA," Consumers Union said. Some advocates say the industry already has too much sway over the agency because of user fees that finance the approval process.
- see the user-fee article in the Star-Ledger
- read the Wall Street Journal story
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