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Finish drug safety bill to get FDA moving on reforms

Tuesday, July 31, 2007

Congress Must Finalize Drug Safety Legislation ASAP to Get FDA Moving Quickly on Reforms

Patients would know sooner about risky meds like Avandia with legislation

(Washington, D.C.) – Consumers Union is urging Congress to finalize and send to the President strong prescription drug safety legislation before recessing for a month-long summer break in order to get the FDA moving sooner on reforms that will help the public learn more quickly about risky medications like Avandia.
An FDA advisory committee Monday voted to keep Avandia on the market with warning labels even after finding that it raised the risks of heart attacks. Concerns about Avandia’s heart attack risk first arose in 1999. A study published in the May New England Journal of Medicine linked Avandia to a 43 percent increased risk of heart attack, prompting the latest review of the drug.
“The most disturbing thing about the FDA advisory committee on Avandia is the lack of good research that has been done on the safety of this drug after eight years of warnings,” said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports. “That’s why it is a matter of life and death that the Congress quickly pass strong drug safety reform legislation and send it to the President.”
Both the House and Senate have passed significant drug safety reform legislation that would, among other things, require drug companies to make public the results of their clinical trials, require post-market safety studies and create a system to monitor drugs for safety problems once they are on the market. The two bills have differences which require a conference committee, and the conference has yet to be formally held.
It has been estimated that actively mining large health databases in the legislation could more quickly pick up safety problems in drugs on the market. For example, it has been estimated that Vioxx’s dangers would have been detected in about three months. Vioxx was removed from the market in 2004, several years after the first studies found it increased heart attack and stroke risk.
At Monday’s meeting, FDA drug safety reviewer David Graham, who also studied Vioxx, called for withdrawing Avandia, estimating that its toxic effects on the heart had caused up to 205,000 heart attacks and strokes from 1999 to 2006, according to press reports.
“Legislation should be passed immediately by Congress so that the new drug safety systems can be developed and implemented,” Vaughan said. “Each day Congress delays is another day before we have a good drug safety system in place.”
A free Consumer Reports Best Buy Drugs report on oral diabetes medicines released on July 16 discusses Avandia in the context of the treatment choices people with diabetes face.
Contact: Bill Vaughan, Susan Herold, 202-462-6262