Congress Should Avoid Efforts To 'Manage' Prescription Drug Safety Risk In Bill To Reauthorize PDUFA, Opinion Piece States

Main Category: Public Health
Also Included In: Pharma Industry / Biotech Industry;  Pharmacy / Pharmacist
Article Date: 20 Jun 2007 - 15:00 PDT


"Congress would do well to strip out the efforts to 'manage' risks and thus regulate medical practice" from legislation to reauthorize the Prescription Drug User Fee Act and focus on efforts to "improve measures for surfacing safety-related information through advances in postmarket monitoring," former FDA deputy commissioner Scott Gottlieb, a physician and resident fellow at the American Enterprise Institute, writes in a Wall Street Journal opinion piece. The Senate version of the bill includes a Risk Evaluation and Management Strategy, or REMS, provision that would provide FDA with "legal power to restrict the doctors who can prescribe drugs and even which patients can purchase them," according to Gottlieb.

The current system for "monitoring drugs after approval for both new benefits as well as side effects is woefully inadequate," but "there are problems when federal authorities impose rigid solutions on a diverse health care system ill-equipped to deal with one-sized approaches to care and on patients and doctors that require latitude to exercise individual preferences in their treatment plans," Gottlieb writes. He adds, "All of these ideas about 'managing' risks by regulating medical practice assume that safety is a binary event" -- that "products are completely unsafe and ineffective until the day they are approved for marketing and then made fully safe the day after" -- but the "reality is that information about risks and benefits ... is an evolving continuum."

FDA "will eventually find that it is folly to endeavor to regulate medical practice," Gottlieb writes, adding, "Trying to do so is going to set the agency up for failure, although a lot of obstacles and uncertainty will be credited along the way." He writes, "Ultimately, the agency cannot regulate away the fact that some doctors and patients deliberately disagree with the agency's advice or mistakenly ignore important warnings" (Gottlieb, Wall Street Journal, 6/18).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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