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Senate to Take Up Drug Ads in PDUFA Reauthorization Bill

April 30, 2007 - by Donny Shaw

The first order of business as the Senate returns this week will be the reauthorization of the Prescription Drug User Fee Act, or PDUFA. Depending on how things go down on the Senate floor, the bill could contain a provision targeting pesky advertisements, like the one pictured on the right, that mislead consumers about the safety and benefits of drugs.

PDUFA was originally authorized by Congress in 1992 and it has been reauthorized every five years. The main purpose of the bill is to allow the Food and Drug Administration (FDA) to collect “user fees” from companies that manufacture pharmaceuticals and medical devices in order to fund safety testing and the FDA approval process. This fee agreement should have no trouble finding enough support to be reauthorized, but other provisions in the bill might run into some opposition.

The bill is tweaked a bit each time it is reauthorized, and this time is no different. The proposed 2007 reauthorization, which is being spearheaded by Ted Kennedy (D, MA), would increase the amount of fees collected by the FDA and expand the scope of their safety tests by giving them the authority to review direct-to-consumer prescription drug advertisements.

The FDA legalized direct-to-consumer drug ads in 1997 under the premise that the ads could be helpful in educating the public about their options in treating illnesses. However, they began to come under criticism in 2004 when the heavily-advertised painkiller Vioxx was taken off the market because it was found to greatly increase the risk of heart attacks. Critics of drug ads generally argue that they manipulate consumers by exaggerating benefits and burying side-effects in fine-print and technical language, while wildly promoting drugs that have not been adequately tested.

Senator Pat Roberts (R, KS) has expressed concerns that the provision to allow the FDA to review drug ads violates the companies first amendment right to free speech. “These provisions fly right in the face of the Constitution,” he said. “This turns the FDA into an editorial review board.” Roberts’ amendment to strike this provision from the bill was rejected when the bill was being considered by the Senate Health, Education, Labor, and Pensions Committee, but he has indicated that he will bring up his concern again on the Senate floor where he may find some support from pro-business senators.

Some other new provisions that the 2007 PDUFA reauthorization proposes include the creation of a public registry of clinical trials and their results, new safeguards to prevent conflict of interests on the FDA’s scientific advisory committees, and putting medical marijuana under FDA regulation.

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