Tuesday, Dec. 6, 2005
Consumer Reports articles cites serious flaws in US drug safety system
(Washington, D.C.) – An investigative report in the January issue of Consumer Reports finds that millions of Americans may have been exposed to rare but serious side effects of 12 relatively common types of prescription drugs currently on the market, underscoring the need for Congress to act now to reform the nation’s drug-safety laws.
The dozen drug types are used to treat common, non-life threatening conditions such as acne, eczema, menopause and head lice and the risks – including an increased likelihood of heart attack, stroke, cancer or suicidal tendencies – were undetected or underestimated when they were approved by the FDA.
The story, which can be accessed at www.ConsumerReports.org, illustrates serious flaws in the U.S. drug safety system, most notably weak safety laws, lack of transparency in the pharmaceutical industry and a rush to approve new medicines.
“Congress has had legislation before it for months that would fix these gaping holes in our drug safety system, but sadly for consumers, it hasn’t acted,” said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports.
“How many more incidents like Vioxx or Paxil will it take before Congress pays attention to the very real problem of drug safety?”
Consumers Union supports legislation by Senators Grassley and Dodd (S. 470 and S. 930) and Rep. Waxman and others (HR 3196) that would address these gaps in our drug safety system. These bills would provide for:
• The full disclosure of clinical drug trials so researchers, physicians and consumers can better understand the safety and side effects of drugs (S. 470 and HR 3196);
• More authority and resources for the FDA to research and monitor the safety of drugs once they are approved, change warning labels, and require that advertisements be clearer about the risks and benefits (S. 930).
“These common-sense reforms will significantly improve drug safety while still ensuring life-saving drugs and therapies get quickly to market,” Vaughan said. “We urge Congress to enact drug safety legislation now before the public is subject to more cases of unnecessary injury or death.”
Bill Vaughan, Susan Herold (policy) 202-462-6262
Joan Quinn (CR story) 914-378-2436