Reforms Give FDA New Authority to Order Drug Safety Studies
Reviewed by Louise Chang, MD
Sept. 21, 2007 -- Congress passed a package of new drug safety rules giving the FDA more power to regulate drug companies, their products, and their advertisements.
By completing final action on the bill Thursday evening, the Senate sent it to President Bush for final approval. He is expected to sign the measure.
The reforms give the FDA new power to order drug companies to perform clinical trials on medications once they're on the market. Today the agency often asks for such trials as a condition of a drug's approval, though agency officials have complained that companies often do not follow through on commitments to conduct them.
The agency is also to get new authority to order changes to drug labeling based on new safety information, and to more closely scrutinize direct-to-consumer advertisements that companies use to promote drugs in magazines and on television. The bill increases fines the agency can levy on companies if they make false or misleading statements in their ads.
Congressional action came years after FDA watchdog groups began calling for reforms at the agency. Three years ago, the pharmaceutical company Merck pulled its blockbuster arthritis drug Vioxx off the market following evidence it increased the risk of heart attack and stroke. The recall led to congressional hearings in which the FDA's own scientists accused senior agency officials of pressuring them to alter scientific judgments about drug safety.
The reforms passed this week fell short of what many lawmakers said was necessary to assure U.S. consumers their medicines were safe.
Still, members of both parties backed what many said was a compromise designed to improve the FDA without further delay.
"The legislation the Senate approved today renews our commitment to protecting the health of American families from potentially dangerous drugs and contaminated food," Sen. Edward Kennedy, D-Mass., chairman of the Health, Education, Labor and Pensions Committee, said in a statement.
Sen. Mike Enzi of Wyoming, the committee's senior Republican, said, "Today we have risen above partisan politics to deliver a monumental victory for all Americans who want peace of mind that the drugs they purchase to treat illnesses and chronic medical conditions are safe and effective."
The reforms included new incentives for companies to test their drugs for safety and effectiveness in children. Under the bill, firms can earn an additional half-year of market exclusivity by performing the tests.
The changes were attached to a bill reauthorizing a program known as the Prescription Drug User Fee Act (PDUFA). The program allows companies to pay nearly $400 million over the next five years directly into the FDA in exchange for faster drug approvals.
Congress sent the bill to the president just days before the program was set to expire on Sept. 30.
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