Rx Comparative Effectiveness Research Funding May Be Delayed Until After Elections
This article was originally published in The Pink Sheet Daily
Executive Summary
Current version of the HHS funding bill does not include appropriations for a comparative research agenda authorized under the Medicare law. AHRQ will nevertheless submit initial research priorities to Congress in the next couple of weeks.
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HHS is concerned that a hold-up in the fiscal year 2005 appropriations process may delay comparative effectiveness research funding until after the November elections. The Agency for Healthcare Research & Quality was directed to develop a comparative effectiveness research agenda under the Medicare Modernization Act of 2003. However, the $50 mil. authorized by the bill (for fiscal year 2004) has not yet been appropriated. AHRQ has begun the initial work on developing the research agenda. However, the funding is not included in the fiscal 2005 HHS appropriations bill reported out of the House Appropriations/HHS Subcommittee July 8. The bill leaves AHRQ funding relatively flat at $42 mil. for the year. The full House Appropriations Committee is scheduled to mark-up the HHS funding bill July 14 at 10 a.m. at 2358 Rayburn House Office Building. The Senate has not yet begun work on 2005 appropriations for HHS. Sen. Majority Leader Bill Frist (R-Tenn.) had plans to push for funding for the comparative effectiveness research provision (1 (Also see "AHRQ Comparative Effectiveness Research Supported By GOP; Too Late For Budget Request" - Pink Sheet, 2 Feb, 2004.)). AHRQ plans to submit an initial list of research priorities to Congress in coming weeks, AHRQ Director Carolyn Clancy said July 12. "The first initial wave of priorities will be submitted from the Department to Congress in the next couple of weeks," Clancy said at a "Translating Research Into Practice" conference co-sponsored by AHRQ, the National Cancer Institute and the Department of Veterans Affairs. "These are priorities identified by those running federal programs, Medicare, Medicaid and the State Children's Health Insurance Program," Clancy said. The initial list will focus on prescription drugs, AHRQ said, although the Pharmaceutical Research & Manufacturers of America is advocating a broader focus on disease burden (2 (Also see "AHRQ Comparative Research Should Focus On Diseases, Not Drug Classes, PhRMA Says" - Pink Sheet, 20 May, 2004.)). Under the Medicare Rx law, HHS was to have completed the priority list by June 8. After the list is sent to Congress, the agency is supposed to have 18 months to "complete the evaluation and synthesis of the initial research." Without any supplemental appropriations, that target appears very unlikely. Clancy concluded that the effectiveness research authorized by the Medicare law provides "a new opportunity for us - at this moment an unfunded opportunity - but an opportunity nonetheless." [ Editor's note : The advantages and challenges of conducting practical clinical studies versus randomized clinical trials will be discussed during a July 20 audio conference hosted by FDC Reports, Inc. For information on Drug & Device Dialogue, visit 3 www.fdcreports.com/dialogue or call 800-332-2181.] - Benjamin Lum |