Examining the FDA's Approval of Vioxx

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What reforms are being considered to the FDA approval process after the Vioxx affiar?

Examining the FDA's Approval of Vioxx

Critic Dr. David Graham has argued that the FDA needs two separate arms; one to evaluate the benefits of using a drug and how safe it is before it is made available to the public and another to independently evaluate drug safety once it's out there. He also said that the FDA's focus is tied too closely to serving the pharmaceutical industry instead of serving the public. "Right now 80 percent of FDA resources are focused on reviewing and approving new drugs for the market," Graham said at a recent conference. "At least 50 percent should be focused on making sure they're safe once they're out there", he said.



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