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Safe and Affordable Prescription Drugs

 

What's New

Victory! The strongest drug safety bill in decades passed out of Congress on September 20th. This bill culminates a three-year campaign by CALPIRG to prevent another Vioxx-type tragedy and ensure that doctors and patients have the most accurate information possible about the prescription drugs they prescribe and use.

 Among other changes, the bill requires drug makers to release the results of their safety studies on-line.  No more hiding unflattering or dangerous results.  This will help patients and doctors figure out if the drug's risk is worth its benefits.

The bill also authorizes the FDA to issues fines of up to $10 million for drug makers who fail to complete follow-up drug safety studies.  Drug makers used to routinely ignore follow-up studies.  The threat of this stiff fine should get their attention.



Overview

Pharmaceutical companies make important life-saving medicines. But that shouldn't give them license to drive up drug prices, ignore the risks of harmful side effects, or block needed reforms in California and in Congress. Consider:

• Pharmaceutical companies use direct-to-consumer ads to sell their latest, most expensive drugs. The industry claims that these ads help to educate consumers. But that doesn’t compute with the fact that a CALPIRG analysis of FDA records for the years 2001-2005 found that the ads for 150 different drugs were false or misleading.

• Merck, the manufacturer of Vioxx, continued to market its painkiller to doctors and patients years after the company had substantial evidence of increased the risk of heart problems. FDA researchers estimate that, in less than 5 years, Vioxx may have caused as many as 139,000 heart attacks and strokes.

• When Congress created the Medicare prescription drug benefit, the pharmaceutical industry and its lobbyists inserted a provision that prohibits the program from negotiating bulk-rate discounts for drugs.

CALPIRG is working to require drug companies to fully disclose studies and information about the safety and effectiveness of their drugs, to enable the FDA to better crack down on pharmaceutical companies that fail to conduct safety tests or mislead doctors and the public through their advertisements, and to allow Congress to negotiate drug discounts for the Medicare program.

 

 

 

 

 

 

 

 




DECEPTIVE AD PULLED—The drug Paxil, intended to treat social anxiety disorder, made headlines for side effects like teen suicide and severe withdrawal symptoms. Drugmaker GlaxoSmithKline ran television ads that promised relief from shyness and self-consciousness, expanding the scope of the drug. The FDA later pulled the ad. (Source: FDA’s letter to GlaxoSmithKline)

News

House Passes Prescription Drug Safety Reforms

The House today passed significant reforms to the Food and Drug Administration’s drug safety review system. Part of a comprehensive FDA bill, the bill was a compromise between Senate and House legislation that passed overwhelmingly earlier this year. The bill, which includes strong consumer protections, will be voted on in the Senate tomorrow. 

Senate Passes Drug Safety Legislation: Bill Will Protect Patients From Unsafe Medicines 

In a victory for consumers, the Senate today passed the “Food and Drug Administration Revitalization Act” sponsored by Senator Ted Kennedy (D-Mass.) by a vote of 93 to 1.

Newsroom



Reports

Paying the Price: The High Cost of Prescription Drugs for Uninsured Americans

7/11/2006 Millions of uninsured and underinsured Americans struggle to afford the medicines they need, even forgoing medically necessary drugs when prices are out of reach. Download Report

Turning Medicine Into Snake Oil: How Pharmaceutical Marketers Put Patients At Risk

5/3/2006 Prescription drug marketers made deceptive claims to doctors and consumers about 150 different drugs including Vioxx and OxyContin, according to a new report released today by U.S. Public Interest Research Group and the NJPIRG Law and Policy Center. Download Report

 

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