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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

s on the Internet within a year or so. This data will be vital for researchers and physicians because it will include information about how a drug performed in those it was tested on, as well as side effects. More consumer-friendly 'lay' summaries of drug trials may be made available in three years if the FDA can develop rules to help ensure they aren't promotional or misleading.

"One of the biggest consumer victories in this legislation is that it will be harder for drug companies to fudge or hide the results of their clinical trials," said Bill Vaughan, senior policy analyst. "Volunteers serve as human guinea pigs in these drug studies, so the results must be made public so researchers, doctors and the volunteers can know if these drugs are truly helpful or harmful."

Another provision in the Senate bill that would have made it more difficult for patients harmed by an unsafe drug to sue the company in state court was removed.

"Given the FDA and drug industry's sometimes sluggish and deceptive track record of protecting the public, it's vital that a patient be allowed to hold a company accountable in court if they are harmed by unsafe medication," Vaughan said.

The legislation includes:

-- Nearly $400 million over the next five years in increased industry

user fees to help pay for improved drug safety monitoring, and it

more effectively includes consumers in future user fee negotiations.

It also gives the FDA increased authority for the safety of drugs

once they are already on the market, such as requiring companies to

add warning labels and conduct post-market safety studies.

-- The FDA could make companies submit their television drug ads for

review prior to running them if there are safety concerns, and

includes heavier fines for running misleading ads. Consumers

also should notice one important change in drug advertisements --

all print ads w
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SOURCE Consumers Union
Copyright©2007 PR Newswire.
All rights reserved

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