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CU: Public must get full story about drug risks

Tuesday, June 12, 2007

FDA Reform Must Ensure Public Gets Full Story about Prescription Drug Risks

CU Urges House Panel Tuesday to Support Pallone Drug Safety Reforms

(Washington, D.C.) – Saying the public is not always being given the full story about prescription drug risks, Consumers Union Tuesday will urge the House health subcommittee to pass comprehensive reforms to prevent drug companies from hiding negative side effect information, and to give the FDA more authority to respond to drugs on the market with safety issues.
“Drug safety is not a dry and abstract issue, it is a matter of life and death,” said Jim Guest, CEO and president of Consumers Union, publisher of Consumer Reports. Guest is slated to testify Tuesday before the House Energy and Commerce Health Subcommittee supporting a drug safety reform proposal from chairman Rep. Pallone.
Click here to read Guest’s complete written testimony.
Consumers Union took out a full-page ad in Tuesday’s USA Today featuring Patricia Slingo, who took Vioxx for her arthritis for two years. The Florida woman ultimately had angioplasty, stents placed in her heart and bypass surgery. The drugmaker continued to heavily market Vioxx despite mounting evidence it could increase heart problems. “I can’t say for certain Vioxx caused my heart problems, but I wish I would have known what the drugmaker knew,” Slingo says in the ad.
“Patricia’s experience with Vioxx shows the gaping holes in our nation’s drug safety system,” Guest said of the ad, which caps CU’s two-year battle to strengthen drug safety laws. “The public is not being given the full story about all the potential risks of medications, and therefore they can not make informed decisions about their healthcare.”
Consumers Union supports Chairman Pallone’s proposal, which builds on legislation passed in the Senate last month by requiring all new drugs display a symbol that they are new to the market; that all new drugs go through a risk evaluation process that can include temporarily limiting direct-to-consumer ads for those drugs with severe and unusual safety issues; and granting only one conflict-of-interest waiver per drug advisory committee.
The House measure also sets out guidelines for how the drug industry must register and report their clinical drug trials to make them publicly accessible. The Senate bill calls for a 30-month study and rulemaking for those trial results guidelines, and it is unclear how comprehensive the final proposal will be.
Consumers Union is urging the House panel to improve the authority and independence of the drug safety office within the FDA, and to ensure FDA scientists who raise safety questions are not retaliated against, and can have their concerns publicly addressed.
“We need a focal point within the FDA where safety issues can be raised, vetted and acted on, not ignored or shunted aside, as is the case now,” Guest said.
Consumers Union also supports the House proposal which allows the FDA to temporarily limit massive ad campaigns for those drugs with severe safety concerns. Additionally, CU is urging the House panel to approve meaningful fines on companies that run misleading ads. The penalties likely would encourage drug companies to use the FDA’s proposed voluntary DTC user fee program, which lets companies get their ads pre-cleared in exchange for paying a user fee.
“There is no incentive right now for a drug company to get their ad reviewed by the FDA before they run it. If they were to get slapped with big fines for running misleading ads, we’d likely see many more drug companies ask the FDA to approve their ads before running them,” Guest said.