Title: Update on Comparative Drug Effectiveness Legislation
Author:
Section/SPIG: Medical Care
Issue Date:
At the November 2003 Annual Meeting, APHA’s Governing Council approved our resolution entitled “Supporting legislation for independent post marketing (Phase IV) evaluation of pharmaceuticals.” This resolution provides a rationale for greater emphasis on independent assessment of pharmaceuticals than currently exists, specifically through:
- Clinical trial designs that fairly compare target drugs to established alternatives (comparator drug) as well as to placebo; and
- Adequate federal funding of independent (typically, academic) investigators to conduct such studies to assure independence from pharmaceutical industry support.
Last June, U.S. Rep. Tom Allen of Maine introduced HR 2356 (The Prescription Drug Comparative Effectiveness Act), bipartisan legislation to authorize $50 million for the National Institutes of Health and $25 for the Agency for Health Care Research and Quality (AHRQ) to support comparative effectiveness research.
Section 1013 of the new Medicare law draws on that, expanding its research agenda to cover “the outcomes, comparative clinical effectiveness, and appropriateness of health care items and services (including prescription drugs); and…strategies for improving the efficiency and effectiveness of [the Medicare, Medicaid and SCHIP] programs…"
However, having been written with considerable input from the pharmaceutical industry, Section 1013 also provides for broad ongoing stakeholder consultation on the research agenda, while limiting the government's authority to set standards of practice based on the research findings. It seems fair to see this as a setback in the quest for independent evaluation envisaged in Representative Allen’s bill.
Section 1013 requires the development of an initial priority list six months after enactment of the legislation (June 2004) and completion of the initial research syntheses 18 months thereafter (December 2005). The latter is being construed to mean that a review of extant findings and pertinent research already under way is to be completed by December 2005.
There has yet to be any funding for Section 1013, but implementation is proceeding at the level of planning. This is detailed at <http://www.medicare.gov/MedicareReform/researchtopics.asp>.
There we learn that, “Because the statute requires annual appropriations for funding the research and other activities authorized by this Section, the [HHS] Department will link the timetable for the priority-setting process for FY 2006 and subsequent years to its process for development of the Department's budget..."
“To meet the requirement for ongoing consultation with other stakeholders, the Department will issue a specific solicitation for research recommendations every year, will permit stakeholders to submit research recommendations throughout the year, and will host a series of listening sessions with different sectors of the health care community to provide additional opportunities for submitting recommendations.”
However, “...the initial priority list should be directed toward evaluating existing evidence regarding the comparative clinical effectiveness of prescription drugs in anticipation of the Medicare prescription drug benefit. Therefore, the Department requests that recommendations for the initial priority list focus on prescription drugs, although all recommendations will be considered.”
The first call for research-priority recommendations had a May 7, 2004 deadline. Submissions are being posted on the Web, at docket no. 2004S-0170, on <http://www.fda.gov/ohrms/dockets/dockets/dockets.htm>. The docket was last updated on April 20, 2003 and showed only two submissions. One submission proposed looking at the problem of physician access in underserved areas. The other cited the need to guarantee lifetime immunosuppressant coverage for kidney transplant patients.
HHS hosted a town hall meeting on Friday, May 21, 2004, to solicit input on research priorities under Section 1013. Participants were expected to discuss the implications of Section 1013.
Section 1013, notwithstanding its broader topical scope, represents a significant setback in the effort to institute a process for independent comparative evaluation of pharmaceuticals. However, there are several actions that the Medical Care Section and other advocates might take to assure continuing movement toward eventual realization of Representative Allen’s initiative. These include:
- Advocate for education and debate on this issue among health professional training programs because our current and future researchers come from their ranks.
- Call your representative and senators to share information on our resolution and verify or ask for their support for continuing action.
- Help build a coalition of advocates among professional associations and consumer groups to make independent assessment of drug effectiveness and safety issues a major priority.