Senator Calls for Independent Drug Safety Office

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A key congressional critic of the FDA says he will soon begin an effort to overhaul the way the agency monitors the safety of the nation’s prescription drug supply.

His bill is likely to be the first attempt by lawmakers to reform the FDA in the wake of lingering questions over its handling of safety issues, including suicide risk in adolescents taking antidepressants and heart problems with Vioxx (search) and similar drugs.

Sen. Charles E. Grassley, R-Iowa, who leads the Finance Committee, says he will introduce a bill designed to set up within the FDA an independent drug safety office with expanded new powers to police -- and possibly remove -- drugs already on the U.S. market.

The FDA’s existing Office of Drug Safety is under the authority of its Office of New Drugs, which is responsible for declaring new drug products safe and clearing them for sale to consumers.

Critics have said that the arrangement intimidates FDA scientists who raise safety questions about already available drugs because they are forced to take their concerns to superiors who have already declared the drugs safe and effective.

New Drug Safety Office, New Power

A current draft of the new bill instead creates an independent drug safety office with the power to force manufacturers to tighten drug warning labels and to order new drug safety trials for products already on the U.S. market.

The bill is also likely to give the new office the power to suspend advertising of suspect drugs and to pull drugs from the market that it determines are unsafe for patients to use, a Senate aide tells WebMD.

“The existing Office of New Drugs is hampered by real and perceived conflicts of interest. An independent drug safety office would more effectively regulate drugs once they’re on the market,” Grassley said in a speech before the Consumer Federation of America.

“If you want accountability, it doesn’t make sense to have the office that reviews the safety of drugs to be under the thumb of the office that puts the drugs on the market in the first place,” he said.

The FDA lacks the authority to force drug companies to conduct additional safety trials on drugs already on the market or to order changes to warning labels.

The Office of Drug Safety came under public scrutiny last year when several of its scientists said the FDA had tried to prevent them from telling the public about safety concerns with several available drugs.

Andrew Mosholder, MD, publicly complained last winter that agency superiors barred him from presenting findings of a study that showed that widely used antidepressant drugs can raise the risk of suicidal thoughts and behaviors in children and adolescents. Later, in November 2004, scientist David Graham, MD, complained to Grassley and other lawmakers that his superiors ostracized and intimidated him when he raised questions about the safety of Vioxx.

Both scientists were eventually allowed to present their findings in front of FDA scientific advisory committees.

Vioxx was pulled from the market by its manufacturer, Merck & Co., in September of last year.

“We now know that the FDA has gotten too complacent. The agency charged with protecting the public from unsafe prescription drugs was too cozy with the with the drug companies,” Grassley says.

Other lawmakers have pledged to launch their own FDA reform efforts but have so far not unveiled any detailed plans.

FDA Resists Shuffle

Sandra Kweder, MD, deputy director of the FDA's Office of New Drugs, told lawmakers in hearings last week that a stronger ability to require label changes “would be helpful” and that the agency should also have the ability to order new clinical trials.

But the agency remains opposed to creating an independent drug safety office. Kweder told lawmakers last week that keeping the agency’s current structure is critical to giving safety officers “a full understanding” of risks before and after drugs go on the market.

“In fact, our [office of drug safety] is independent,” she said in testimony before the Senate Heath, Education, Labor, and Pensions Committee.

Officials instead announced plans several weeks ago to create a safety monitoring board made up of FDA scientists and outside experts. Some lawmakers criticized the move as insufficient.

The agency did not respond to requests for comment Thursday.

Grassley says he will formally introduce his bill “in a few days, maybe a week or two.”

By Todd Zwillich, reviewed by Michael W. Smith, MD

SOURCES: Sen. Charles E. Grassley (R-Iowa). Sandra Kweder, MD, deputy director, FDA Office of New Drugs.