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Panel urged to tell Congress now of needed drug safety reforms

Contact: Susan Herold, 202-462-6262
Wednesday, June 8, 2005

IOM Panel Urged to Immediately Recommend that Congress
Toughen Drug Safety Laws to Save Lives

Consumers Union testifies that obvious safety problems need action now

(Washington, D.C.) – Consumers Union today told the scientific panel studying the nation’s drug safety system that it should immediately recommend to Congress “obvious” fixes to help save lives, such as requiring drug makers conduct studies when safety problems first arise, heavily fining those companies that fail to comply, making public all clinical drug trials and creating a strong Office of Drug Safety.
“Each day, people are being harmed by unsafe drugs as the Congress, the FDA and the pharmaceutical industry endlessly debate the obvious fact our drug safety laws are inadequate,” Bill Vaughan, senior policy analyst for Consumers Union, told the Institute of Medicine Committee on Assessment of the U.S. Drug Safety System.
“This study is important, but we shouldn’t wait months or possibly years for a study when we can fix well-known problems now,” Vaughan added. “We encourage the panel to make interim policy recommendations to Congress that will ensure fundamental drug safety reforms now.”
To read Consumers Union testimony to the IOM panel,CLICK HERE
The IOM committee was called for in November by the Food and Drug Administration to study the drug safety system after several high-profile drugs – including Vioxx and Paxil – were found to have safety problems and dangerous side effects, some of which had been known for years by the drug makers and the FDA. However, the IOM committee isn’t expected to report its findings until sometime next year.
Consumers Union, one of the first groups to testify at the IOM hearings, said as the panel studies longer-term issues such as the creation of an effective safety-monitoring system, it should act immediately on well-documented problems. These include the ability for drug makers to suppress clinical drug trials that may reveal harmful side effects because the law does not require they be made public. Another failure is the lack of FDA authority to require drug makers perform safety studies once their product is on the market and potential harms surface.
A February FDA report found drug companies have failed to begin 68 percent of the post-market safety studies they have promised. And last week, Rep. Ed Markey (D-MA)released a report that found nearly half of the preliminary safety and efficacy studies required by drug companies in exchange for fast-track approval of their drugs had not been completed.
“Two-thirds of the promised safety studies have not been started – in some cases years after the commitment was given,” Vaughan said. “The drug industry sees the FDA as a paper tiger, and the agency needs the authority to require these studies and impose penalties that will get some action on this safety backlog.”
In addition to FDA authority to require post-market studies and impose fines for failing to comply, Consumers Union urged the panel to immediately recommend that Congress:
 Require all clinical drug trials be registered and their results made public.
 Establish an Office of Postmarket Drug Safety that has the resources, authority and autonomy from the divisions that approve new drugs.
 Give the FDA clear authority to require drug label changes and impose post-market risk management steps when safety issues arise.
 Impose penalties on the industry for running advertising that repeatedly fails to warn of dangers.
 Provide greater and more dependable dollars for post-market safety follow up.
Consumers Union also recommended the Committee address longer-term improvements, including how FDA should move from a passive post-market safety system to a more active, aggressive system using high-quality data; striking an appropriate balance between a drug’s risks and its benefits at the time of approval; require comparative trials between competing drugs to determine if new drugs are any more effective or safe; and addressing the problem of drug company promotion to doctors which results in inappropriate treatment decisions.