FDAnews
www.fdanews.com/articles/63230-frist-will-seek-more-funding-for-comparative-trials

FRIST WILL SEEK MORE FUNDING FOR COMPARATIVE TRIALS

October 11, 2006

Senate Majority Leader Bill Frist (R-Tenn.) plans to use a recent Congressional Budget Office (CBO) report on drug industry R&D to get additional federal funding for comparative drug trials, a congressional source says.

Frist will use the report, "Research and Development in the Pharmaceutical Industry," to bolster HHS' Agency for Healthcare Research and Quality's (AHRQ) comparative trial program, a Frist staffer said. The majority leader will use the CBO report and other data to ensure more funding for the agency as part of the HHS appropriations process, the source added. The report provides "validation of the policy we have pursued."

AHRQ's Effective Healthcare Program, which is authorized under Section 1013 of the Medicare Rx Law, conducts and supports research to determine whether drugs, devices or other means are best able to address issues such as heart disease, cancer and high blood pressure. The program's broader goal is to provide the public with more information about the choices they have in treating these illnesses.

The CBO report found that comparative drug trials could ensure more focused drug industry R&D and help guarantee that the public spends its money on the most effective treatments.

The CBO report, which Frist requested, while not recommending any action, does provide another voice laying out the benefits of comparative trials, as various agencies seek this type of data. The AHRQ, FDA, NIH and the Centers for Medicare & Medicaid Services have all proposed comparative studies as a way to discover the most effective treatments.

Since CBO is Congress' adviser on financial issues, Frist requested three reports on the implications of the prescription drug plan on drug prices. The first report reviewed how the federal government obtains its drug prices for federal programs. The R&D report is the second of these studies. The final study, which also explores drug pricing, is expected in November.

The report examined the role of R&D in the drug industry, analyzed the forces that influence it and determined how well markets are working to deliver new drugs. Drug-versus-drug comparisons "would help drug purchasers make the best choices -- and in turn improve the market signals that guide private companies' decisions about research and development," the report concluded.

(http://www.fdanews.com/did/5_199/)