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Senators seek drug safety center

Watchdog would report to FDA about health risks

WASHINGTON -- The head of a new drug safety center charged with monitoring drug risks would answer directly to the Food and Drug Administration commissioner under a bill introduced yesterday. The measure is intended to eliminate conflicts of interest by separating the FDA's oversight of approved medications from its drug-approval process.

One of the bill's sponsors, Senate Finance chairman Charles Grassley, chided the agency for failing in its drug safety watchdog role. ''Some say we need a Rottweiler, as opposed to a Chihuahua," he said.

The proposal would create the Center for Postmarket Drug Evaluation and Research. Its director could require safety studies that most drug companies now fail to complete, update drug labels, and alert consumers to high-risk drugs and restrict their use. In extreme cases, the director could ask the FDA commissioner to pull a drug from the market.

Grassley last fall held a high-profile hearing after the painkiller Vioxx was withdrawn from the market in September. A senior FDA employee, David Graham, testified that a power imbalance within the FDA allowed questionable drugs to continue to be sold despite objections of drug-safety staff.

Congressional testimony during the Vioxx hearing made it clear ''the present setup is wrong, wrong, wrong," said Grassley, an Iowa Republican.

The proposal, cosponsored by Senator Christopher Dodd, a Connecticut Democrat, provides $500 million in funding to the center over five years. Last year, $272.2 million was allocated to monitor the safety of medications on the market, while $575.9 million was earmarked for the FDA's powerful Office of New Drugs.

An FDA spokeswoman declined to comment on the legislation, which is expected to be discussed by the Senate's Health, Education, Labor and Pensions Committee.

Health and Human Services Secretary Michael Leavitt said yesterday in a speech that the FDA's pledged improvements, including its own version of a new drug-safety oversight board, will provide ''the level of independence" needed to address drug safety concerns.

Meanwhile, a sweeping FDA reform bill cosponsored by Senators Michael Enzi and Edward M. Kennedy is expected to take shape after another round of drug-safety hearings in early June.

Enzi, a Wyoming Republican and chairman of the Health, Education, Labor and Pensions Committee, has said he will fight the establishment of an independent drug safety office because it would overemphasize risks and minimize benefits.

Nonetheless, Grassley said he was optimistic the bipartisan proposal could become an amendment to the bill sponsored by Enzi and Kennedy, a Massachusetts Democrat.

Consumer advocates said the new oversight center proposed by Dodd and Grassley would increase public awareness of drug risks.

Under the proposed law, advertising for new drugs, risky drugs, and products whose manufacturers have not yet completed additional clinical trials would have to be previewed by the new FDA safety center. Advertising for drugs that pose significant public health risks would have to prominently display that information in plain language.

Some members of Congress, including Kennedy, have expressed concern about advertising campaigns that turn niche drugs into bestsellers before all of their health risks become known.

Dodd said drug company promotions can drive the number of prescriptions written by doctors.

''If you're getting wider-spread dissemination of a product through advertising, it seems to me you've got to consider that as well," he said.

Most drug companies voluntarily submit broadcast advertisements to the FDA prior to airing and they typically include summaries of drug risks, said Daniel Troy, former FDA chief counsel. But requiring preview by the FDA ''raises some very serious constitutional questions," said Troy, who now works at the Washington-based law firm Sidley Austin Brown & Wood. Advertising is protected as free speech under the First Amendment.

Troy said Congress could improve the quality of drug advertising by allowing the FDA to more easily update its rules.

''Part of the problem now is that the regulations are totally outdated because they really are written for a world where all promotion went to doctors, and not direct to consumers," he said.

Diedtra Henderson can be reached at dhenderson@globe.com.

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