Faster drug approval . . . for a fee
The FDA and the pharmaceutical companies have come up with a new proposal for a program that charges drugmakers fees to speed up FDA approval process, but critics say it doesn't do enough to protect consumers.
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MARK AUSTIN THOMAS: Today the FDA is holding a public meeting on new plans for the Prescription Drug User Fee Act. This program charges pharmaceutical companies fees to speed up the drug approval process. The act was passed in 1992. Helen Palmer reports from the Health Desk at WGBH, there are strong critics of both the Act and the new proposals.
HELEN PALMER: The FDA and the drug industry jointly came up with the new proposals. The pharmaceutical industry will pay an additional $87 million for the drug approval process. A third of that will monitor the safety of drugs already on the market.
But Arthur Levin of the Center for Medical Consumers says the agreement still falls short.
ARTHUR LEVIN: It needs more enforcement authority, it needs a lot more money, it needs to be held accountable for how well this new money is used to improve safety.
Levin says the industry shouldn’t be paying for the agency that regulates it. And the public’s lost confidence in the FDA, because it approved unsafe drugs like Vioxx.
He doubts if the new proposals can solve that problem.
In Boston, I’m Helen Palmer for Marketplace.