Senate HHS Approps Chair Harkin Looking At FDA Rules On Women In Trials

The representation of women in clinical trials will be a likely hearing topic for the Senate Appropriations/Labor, HHS & Education Subcommittee under incoming Chairman Harkin (D-Iowa).

Harkin, along with Sens. Mikulski (D-Md.) and Snowe (R-Maine), and Rep. Waxman (D-Calif.), requested a General Accounting Office study on FDA practices for inclusion of women in clinical studies (¹ (Also see "FDA Adverse Event Monitoring "Flaws" Highlighted In GAO Transition Report" - Pink Sheet, 22 Jan, 2001.)).

Harkin is expected to hold hearings and introduce legislation following release of the report. Originally anticipated in April, the full report is now expected to be delivered to the requesting parties by the end of June, GAO said.

Hearings on women in clinical trials could touch on FDA's overall safety record in drug approvals. A February interim report by GAO found that eight of 10 prescription drugs withdrawn from the market since 1997 presented more significant health risks for women than men (² (Also see "Recent Drug Withdrawals Had Greater Health Risks For Women - GAO Report" - Pink Sheet, 12 Feb, 2001.)).

Harkin, who is co-chair of the Senate Rural Health Caucus, will bring a rural state viewpoint to healthcare issues. He is particularly interested in Medicare: Iowa leads the nation in the percentage of its population aged 85 and older, the senator's website notes.

The website highlights affordable prescription drugs and a patient bill of rights as healthcare priorities.

"As ranking Democrat on the Senate panel that funds most health programs, I have guided efforts to focus more on prevention and early intervention as a means of reducing costs and improving quality," the website states.

During the 106th Congress, Harkin co-sponsored the Senate Democrat Medicare prescription drug benefit bill introduced by Majority Leader Daschle (D-S.D.), the "Medicare Expansion for Needed Drugs Act of 2000."

Also during the last session, Harkin introduced legislation (S 1451) aimed at improving efforts to combat Medicare fraud, waste and abuse. Included in the bill was a provision to reduce the reimbursement rate for drugs and biologicals from 95% of the average wholesale price to the lowest of the following: 83% of the AWP, the actual acquisition cost, or an even lower amount arrived at by a specified formula.

Harkin is one of 52 senators listed as a cosponsor of legislation (S 41) sponsored by Sen. Hatch (R-Utah) to make permanent the research and development tax credit, which has been a temporary feature of the Internal Revenue Code since 1981.

The Hatch bill would also raise the rates of annual increases in the R&D tax credit. Identical legislation in the House is sponsored by Rep. Johnson (R-Conn.) and has 109 co-sponsors.

The measure was offered by Hatch as an amendment to the tax cut bill, but was not included in final legislation signed into law June 7.

Despite the bill's long list of supporters, the R&D tax credit may not be an immediate priority for reconsideration. The current provision does not expire until 2004.

New Mexico Republican Sen. Domenici, a co-sponsor of the Hatch bill, has introduced similar legislation (S 515) to establish a permanent R&D tax incentive and direct the Treasury Secretary to assist small and start-up businesses in complying with the requirements for the credit.

Sen. Byrd (D-W.Va.) is expected chair the full Senate Appropriations Committee following a final organizational agreement. Byrd identifies a Medicare prescription drug benefit as a focus; he is a co-sponsor of Daschle's bill, the "Medicare Prescription Drug Coverage Act" (S 10).

Wisconsin Democratic Sen. Kohl is expected to chair the Appropriations/Agriculture Subcommittee that oversees the FDA budget. He is also in line for the chairmanship of the Judiciary/Antitrust, Business Rights and Competition Subcommittee. Kohl has shown an interest in patient safety and online privacy issues.

Connecticut Democrat Sen. Lieberman, who has also signed on to the permanent R&D credit, is in line to chair the Senate Governmental Affairs Committee. Lieberman, a co-sponsor of both the Hatch and Domenici bills, is not expected to use the podium to address prescription drug issues.