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Senate Passes Drug-Safety Reforms to Prevent Future Vioxx-type,Disasters; House Urged to Act on Strong Drug Safety Bill

First significant drug safety measure in 45 years; focus moves to House

WASHINGTON, May 09, 2007 /PRNewswire-USNewswire/ -- The Senate today overwhelmingly passed significant prescription drug safety reforms to give the Food and Drug Administration more power to deal with unsafe medicines on the market, moving the issue of drug safety to the House, where a strong bill has been introduced but has yet to be considered.

"The Senate should be congratulated for passing reforms to ensure patients and doctors know more about the risks of their medicines," said Bill Vaughan, senior policy advisor for Consumers Union, publisher of Consumer Reports. "The leadership of Senators Kennedy and Enzi on drug safety reform has been invaluable to getting this through the Senate."

"Too many lives have been lost because the FDA has been too slow to act, or didn't have the power to change a warning label or require a follow-up safety study. It's now up to the House to get the strongest possible reforms approved so patients can have faith in the medicines they take each day," Vaughan added.

S 1082, passed by a 93-1 vote, gives the FDA power to change drug labels and require post-market studies for drugs that have safety problems. It also requires drug makers to register most of their clinical trials - although the legislation gives the FDA 2 1/2 years to develop guidelines for making some, but not all, clinical trial results public.

Consumers Union is urging the House to pass language to make all clinical trial results public immediately to prevent drug companies from downplaying studies which reveal harmful side effects, as was the case with Vioxx and Paxil.

On the issue of direct-to-consumer advertising, an original provision in the Senate bill giving the FDA power to restrict advertising for new drugs with safety indications was removed. It was replaced with a much weaker measure that only allows
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