Lawmakers Seek Drug Safety Reform at FDA

Reacting to wide concerns over prescription drug safety, lawmakers Wednesday proposed a bill to reform the FDA by forming a new independent safety office inside the agency.

The bill would give the office new powers to police the safety of drugs already on the U.S. market, including authority to recommend banning further sales of drugs carrying unreasonable health risks.

The plan also gives the office's director the ability to order drug companies to perform safety studies of marketed drugs and to order changes in direct-to-consumer drug advertisements.

The bill comes more than seven months after the drugmaker Merck pulled its blockbuster pain medication Vioxx from the worldwide market because of safety concerns. The drug was sold to millions of U.S. patients over nearly seven years before evidence that it raised the risk of heart attacks and strokes compelled the company to suspend sales.

The episode spurred scrutiny of other drugs in Vioxx's class, known as Cox-2 inhibitors. Last month another Cox-2 — Bextra — was pulled from the market because of safety concerns. The FDA also asked that new warning labels be placed on other nonsteroidal anti-inflammatory pain drugs.

Last October, FDA safety officer David Graham, MD, complained to lawmakers that his repeated warnings on the safety of Cox-2 drugs were ignored by higher-ups in the agency. Months earlier, another scientist, Andrew Moshholder, MD, complained of intimidation after he warned of new evidence that antidepressant drugs could increase the risk of suicidal thoughts and behaviors in children and adolescents.

Conflict of Interest at the FDA?

The FDA's current structure places monitoring of already-marketed drugs under the authority of the agency's branch responsible for approving new medications. Critics have charged that the arrangement leads to a conflict of interest because scientists who question the risk of drugs already deemed safe wind up in effect challenging the judgment of their superiors in the FDA's Office of New Drugs.

"The new center is needed because the existing Office of New Drugs is hampered by real and perceived conflict of interest," said Sen. Charles E. Grassley (R-Iowa), a sponsor of the bill and chairman of the Senate Finance Committee. "Nobody ever wants to admit they made a mistake."

The bill gives the new postmarket safety office the power to order drug companies to clear advertisements with regulators for any new medication on the market less than two years. The office would also be able to demand prior approval of ads for drugs it determines could pose an unreasonable risk to the public.

Lawmakers said they would request $500 million in spending over five years to pay for the new office.

"This is the kind of bill we think we can build strong bipartisan support for," said Sen. Christopher Dodd (D-Conn.), the bill's other co-sponsor.

An FDA spokesperson declined to comment on the legislation.

The FDA several months ago announced unilateral efforts aimed at steadying public confidence shaken by the handling of Vioxx and other drugs. Officials unveiled plans to launch a broad review of the agency's safety monitoring along with a new safety review panel consisting of internal officials and nonvoting outside experts.

FDA acting Commissioner Lester M. Crawford said in an interview prior to the bill's disclosure that the naming of the panel's experts was "imminent."

Dodd said that the bill was written in consultation with drug manufacturers but that "they haven't embraced it quite yet."

A spokesperson for the pharmaceutical industry's main lobbying group said his organization had not seen the final text of Wednesday's bill but also suggested that the FDA's unilateral reforms were sufficient.

"Clearly consumers should be encouraged by steps already taken by FDA to address drug safety," Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America, said in a statement.

By Todd Zwillich, reviewed by Brunilda Nazario, MD

SOURCES: Sen. Charles E. Grassley (R-Iowa). Sen. Christopher Dodd (D-Conn.). Lester Crawford, acting commissioner, FDA. Ken Johnson, spokesman, Pharmaceutical Research and Manufacturers of America.