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Sidney Wolfe Taking On Larger Role At FDA

Ruzanna Harutyunyan's picture

The Wall Street Journal on Friday examined how, to "the consternation of the drug industry," the appointment of "[d]rug-safety crusader" Sidney Wolfe to FDA's Drug Safety and Risk Management Committee could give one of the leading critics of the pharmaceutical industry "the ear of several health leaders and members of Congress expected to influence FDA policy in the Obama administration."

As head of Public Citizen's Health Research Group, Wolfe has "helped push 16 drugs off the market and slap restrictions on several multibillion-dollar products," according to the Journal.

FDA first invited Wolfe to participate on a March 2008 safety panel, where he helped reject an application from the drugmaker Cephalon to expand use of its painkiller Fentora to children. In April 2008 he was appointed to the panel full time, "at the urging of consumer groups who were owed a seat on the committee," the Journal reports. He will serve a four-year term on the committee.

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According to the Journal, Wolfe believes FDA serves as a "tool" of the drug industry. "The history of the last 20 years is one of crises with drugs and medical devices, many approved despite the objections of the FDA's own scientists," Wolfe said. Wolfe advocates restricting "copycat" drugs, which critics say drugmakers introduce to prevent consumers from switching to lower-cost generics after an original medication loses patent exclusivity, and limits on direct-to-consumer advertising.

Wolfe's critics have stated that "his opinions are just as one sided as those he likes to blast," according to the Journal. Some patient advocacy groups have expressed concerns that if Wolfe "gets his way, FDA approvals for new drugs will involve more bureaucracy, raise the cost of drug trials and keep life-saving drugs from reaching dying patients," the Journal reports.

According to the Journal, Wolfe's opinions on prescription drugs occasionally upset his colleagues. His opposition to painkiller lollipops for children with terminal cancer prompted leading Boston anesthesiologist and drug-safety proponent Maureen Strafford to say, "Is there any drug Sid Wolfe likes?" (Mundy, Wall Street Journal, 1/9).

Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, and sign up for email delivery at kaisernetwork.org/email . The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2007 Advisory Board Company and Kaiser Family Foundation. All rights reserved.