Defective Drugs & the FDA Approval Process

Michael Phelan

Attorney
(866) 735-1102 Ext 375

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FDA Advisory Boards recommend drugs and medical devices for approval. Their votes can greatly effect drug company profits. Lawyers, advocacy groups, and certain members of Congress (e.g., Sen. Charles Grassley) have for years worried that the drug and device makers have hijacked the FDA's approval process by improperly influencing advisory board members through payment of exorbitant consulting fees from the manufacturers to the advisory members. On Wednesday, the FDA announced a new rule that advisers who receive money from a drug or device maker would be barred from voting on whether to approve that company's products. Unless there are undisclosed loopholes allowing the FDA to resort to its current practice of waiving most conflicts rules, this new rule could signal that the FDA is back in the business of protecting consumers, not just manufacturers. In the bad old days, 10 of the 32 members of the advisory panel who voted to allow Bextra to remain on the market and to allow Vioxx to return to the market after it had been withdrawn had taken money from the manufacturers of such drugs.