FDA Mission Should Not Include Rx Cost Effectiveness, Rep. Allen Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Comparative studies should be "untainted" by industry's influence, the Maine Democrat says. He urges full appropriation of funding to AHRQ under the new Medicare law.
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FDA is not the appropriate agency to oversee comparative research involving drugs and devices, Rep. Tom Allen (D-Maine) told a "1 Drug & Device Dialogue" audio conference sponsored by F-D-C Reports and Polidais April 27. "It seems to me that that is the wrong place to locate comparative effectiveness research because we want the research to be independent, untainted by the fact that that particular agency is subject to a lot of influence from the pharmaceutical industry," Allen declared. [Editor's note: To sign up for a replay of the April 27 audio conference, visit www.fdcreports.com/dialogue or call 800-332-2181.] Allen noted that FDA currently has plenty of work to do to review new drugs for safety and efficacy. "They're working and trying to get drugs on the market as soon as they can," Allen said. "All they're doing - which is no small task - is to measure the safety of the drug and its effectiveness as compared to a placebo." By contrast, the goal of comparative effectiveness research is to "develop an antidote to, in my view, the TV ads and the detail representatives." Allen suggested that FDA is not genuinely independent enough to fill that role. "We have to have an independent process, and I don't think the FDA either will do it or is the right place to do head-to-head clinical trials," he concluded. The growing interest in comparative research and cost effectiveness studies has led to suggestions that FDA's mission be expanded. Acting FDA Commissioner Lester Crawford, in fact, believes that Congress will be forced to consider making cost effectiveness a formal part of the agency's mission (2 (Also see "FDA To Adopt Cost-Effectiveness Role? Congress May Revisit Issue, Crawford Says" - Pink Sheet, 30 Mar, 2004.)). Allen supports legislation to expand the role of the National Institutes of Health and the Agency for Healthcare Research & Quality in comparative effectiveness. He also wants to ensure that AHRQ receives $50 mil. authorized under the 2003 Medicare law to set up a comparative research agenda (3 (Also see "Comparative Research Should Start With Rx Drugs, AHRQ Says" - Pink Sheet, 23 Apr, 2004.)). -Katie Harrison |