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House panel: approve strong drug safety bill

Wednesday, June 20, 2007

House Panel Urged to Approve Strong Drug Safety Legislation Thursday and Fight Attempts to Weaken

Drug industry pushing to weaken bill, patient safety must come first, CU says

(Washington, D.C.) – Consumers Union is urging the House Energy and Commerce Committee Thursday to reject any further attempts to weaken prescription drug safety legislation and support proposals that will bolster safety and openness within the Food and Drug Administration.
“Prescription drug safety is a life and death issue for American consumers, which is why it is so critical that House members pass strong drug safety legislation,” said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports. “We know the drug industry is working hard to weaken this legislation, but we hope House members will stay strong and fight for patient safety.”
Consumers Union was disappointed that some measures were weakened in Tuesday’s markup of the bill by the House E&C health subcommittee, most notably the amendment removing the ability for the FDA to temporarily restrict advertisements of drugs with safety issues.
Significant fines for running ads that are misleading should also be included in the legislation so companies will want to use the FDA’s new voluntary drug ad review program.
“The makers of Vioxx made more than $4 million a day in sales from heavily advertising their drug to everyone with arthritis pain, even though there was the potential for serious heart risks from taking it,” Vaughan said. “When you are talking that kind of money, hitting a company with a fine of only $250,000 for running ads that don’t talk about all the risks won’t change a thing.”
However, the subcommittee did add language from Rep. Schakowsky (D-Ill) requiring drug advertisements carry a toll-free number and Web site address so consumers could report adverse reactions from drugs to the FDA. And the panel, led by Rep. Pallone (D-NJ) and Rep. Waxman (D-CA), beat back attempts to strip $225 million in user fees on the industry to fund safety efforts, as well as cut fines on industry for failing to adhere to safety requirements.
“We applaud those members on the subcommittee who supported the strong drug safety legislation introduced by Chairman Pallone. More important, consumers applaud them for protecting them from unsafe drugs,” Vaughan said.
Consumers Union is also urging the full committee to keep the strong clinical trial results language from Waxman and Rep. Markey (D-Mass) that sets out guidelines for how the drug industry must register and report their clinical drug trials to make them publicly accessible within a year. The Senate bill calls for a 30-month study and rulemaking for those trial results guidelines, and it is unclear how comprehensive the final proposal will be.
“It’s critical that drug companies make public the results of their studies, so all of us know about potentially dangerous side effects. The House has the opportunity to make this information available to doctors, researchers and consumers, and stop the foot-dragging by the drug industry,” Vaughan said. “Studies on how to make sure these trial results are honestly presented make sense as long as the final result is that the data from all trials becomes public.”

Bill Vaughan, Susan Herold, 202-462-6262