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Pro-Consumer Drug Safety Reforms Agreed to in Final FDA Bill; Should End Drug Industry Gaming of Safety System
Date:9/19/2007

House overwhelming approves bill, CU says major victory for patients

WASHINGTON, Sept. 19 /PRNewswire-USNewswire/ -- Nearly three years to the day Vioxx was removed from the market, Congress has completed a major drug safety reform bill that will give FDA the power to hold pharmaceutical companies accountable for safety problems, and help ensure the industry can't keep drug risks hidden from the public, Consumers Union said.

"Congress is about to give the President legislation that should end the secrecy and foot-dragging when it comes to letting consumers know about unsafe medicines," said Jim Guest, president of Consumers Union, publisher of Consumer Reports. "These reforms have been anxiously awaited by the millions of consumers who take a prescription drug every day and wonder if they know the truth about its side effects."

"Unfortunately, too many Americans suffered or lost their lives because they weren't given the straight story about safety risks by either the drug manufacturer or the FDA," Guest added. "It's now up to the FDA to enforce this law and make sure we get the straight story on the benefits and risks of drugs on the market."

A compromise was reached today by the Senate and House to reconcile differences between the two drug safety bills (S 1082 and HR 2900) passed earlier this year. The reforms are part of an underlying bill reauthorizing user fees on the pharmaceutical industry to fund the FDA drug approval process. The House approved the bill 405-7 today, with a Senate vote expected later this week. A final bill would then go to the President.

Two vital pro-consumer measures survived the closed-door negotiations - making important clinical drug trial results and adverse events public, and protecting a consumer's right to hold companies accountable in court if they're hurt by an unsafe drug.

The clinical trial language will require companies make public a technical summary of their trial result
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SOURCE Consumers Union
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