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What's New
The prestigious Institute of Medicine (IOM) recently released a highly critical report about the drug safety policies of the Food and Drug Administration (FDA). This confirms what PIRG has been saying for years—the FDA cannot guarantee the safety of our drug supply. U.S. PIRG is supporting strong bi-partisan legislation, the FDA Safety Act (S 930), to give the FDA the resources and authority to effectively regulate the drug industry and protect consumers from unsafe drugs. Currently, the FDA is extremely limited in its ability to both identify dangerous drugs and inform doctors and consumers about drug related health risks.
How You Can Help
Ask your senators to support the Food and Drug Administration Safety Act, S 930, which would give the FDA the authority it needs to protect consumers from dangerous drugs and inform doctors of new drug safety concerns.
Brief Summary
Driving while sleeping, compulsive gambling, teen suicides and heart attacks all have one thing in common: They’re potential side effects of taking prescription drugs. They’re clear examples of how the FDA is failing to guarantee the safety of our nation’s prescription drug supply. However, the most prominent example is the FDA’s handling of Vioxx.
Despite years of warnings from FDA researchers and numerous studies published in prominent journals, the FDA took no significant action to protect consumers from the deadly side effects of Vioxx. The FDA's failure to pull the drug off the market or restrict its distribution resulted in the death and injury of thousands of otherwise healthy consumers.
Tragically, the impetus for action on Vioxx came from the pharmaceutical company and not the FDA. Merck pulled Vioxx from the market after a long-term study financed by the company showed that people taking the drug had more cases of heart attack, stroke or blood clot than people taking a placebo. Since Vioxx went on the market in 1999, the prescription has been dispensed 84 million times. Despite mounting evidence that Vioxx caused serious cardiovascular injuries, the FDA approved Vioxx for use in children less than a month before Merck withdrew it from the market.
Dr. David Graham, an FDA whistleblower, harshly criticized the agency at a Congressional hearing late last year. In his testimony he stated, "Vioxx is a terrible tragedy and a profound regulatory failure. I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless." Dr. Graham estimated that in less than five full years on the market, Vioxx accounted for more than 140,000 cases of heart disease in the United States. More.
Resources
Institute of Medicine’s report: The Future of Drug Safety: Actions Steps for Congress, 9/06
NJPIRG report: Turning Medicine Into Snake Oil: How Pharmaceutical Marketers Put Patients at Risk. 5/3/06
Lindsey Johnson's Comments to the Committee on the Assessment of the U.S. Drug Safety System The National Academies Institute of Medicine 7/19/05
S 930 Fact Sheet FDA Structure (XLS)
U.S. PIRG letter in support of S 930 (DOC)
Letter to Hinchey in support of FDA Advisory Committees rider (PDF)
FDA Finally Takes Action to Stop Sales of Killer Pain-killer 4/13/05 (DOC)
Consumers Groups Laud Dodd/Grassley Bill Mandating Public Disclosure of Drug Study Results 2/28/05 (DOC)
Letter of support for Hinchey bill HR2090 (DOC)
In The News
Study Condemns F.D.A.’s Handling of Drug Safety New York Times, 9/23/06
FDA Told U.S. Drug System Is Broken Washington Post, 9/23/06
