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CU outlines major drug safety reforms for FDA advisory board

Contact: Susan Herold, 202-462-6262
Friday, April 15, 2005

FDA Board Told Proposed Drug Safety Reforms are Inadequate; Major Changes Needed

(Washington, D.C.) – Consumers Union today told an Food and Drug Administration advisory board examining drug safety that the agency’s proposed reforms are inadequate, and called for significant internal changes and new laws that will beef up the agency’s ability to ensure drugs don’t pose unreasonable risks, and remove from the market those that do.
“The FDA’s proposed drug safety program improvements, though welcome, fail to address the agency’s underlying structural and regulatory shortcomings that prevent it from protecting the public from unreasonably risky drugs,” Consumers Union said in comments to the FDA Science Board.
“Without significant reform of the pre- and postmarket safety program at FDA, more drugs will surely be added to the list of safety failures.”
Consumers Union urged the board to recommend the FDA support Congressional efforts to create an independent Office of Drug Safety within the agency, and empower it to require drug companies conduct safety studies of drugs on the market, as well as give it the authority to change warning labels or limit drug advertising when safety problems arise.
The proposed “Drug Safety Oversight Board” that FDA officials have suggested would improve communications to consumers about drug safety problems is a flawed approach, CU said. The board would have no regulatory authority and would serve part-time and ad hoc, inadequate for actively monitoring drug safety.
“The increased and more timely patient and doctor communications about safety risks…does not resolve the core shortcomings that prevent the agency from proactively identifying those public health risks,” CU said.
For the submitted comments and list of recommendations to improve FDA drug safety programs, Click here.