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Pro-Consumer Drug Safety Reforms Agreed to in Final FDA Bill; Should End Drug Industry Gaming of Safety System

ill include a toll-free number and Web site address

for reporting side effects to the FDA, with a study to determine if TV

ads also should contain the info.

-- Reducing by 25 percent over five years the number of FDA advisory

committee members with drug industry conflicts of interest. Currently,

FDA panels that recommend drugs for market often include several

members with financial ties to the companies whose drug is up for

approval, and the FDA routinely waives the conflicts. CU supported a

ban on all waivers, but the limits are a step toward a better

advisory process.

"This law will make critical, life-saving improvements in drug safety in the years to come, though the public may not see many immediate changes," Vaughan said.

Two key changes will immeasurably improve drug safety in the future, Vaughan added. A Senate-inspired provision opens up the internal FDA debate on whether or not to approve a drug, helping outside researchers see where the FDA's safety concerns lie and where more research is needed. "It will help develop a climate of openness and scientific debate within the FDA," Vaughan said.

The other key change will require FDA to monitor massive databases of medical records to detect short and long-term problems with new drugs. This research will also contribute to research on the comparative effectiveness of different medical procedures. "In the long run, this new medical data monitoring program may be the bill's most important contribution to safer and more effective medicines," Vaughan added.

The bill also includes some important first steps on food safety reforms. It authorizes FDA to enhance seafood inspection, urges it to work more closely with states on food safety, and requires certain parties to report incidents where food might be adulterated. It also requires FDA to establish standards for pet food, a response to the deadly pet food ingre

SOURCE Consumers Union
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