ASRM Washington Wire

FDA Moves to Make Emergency Contraception Available Without a Prescription
In August, the FDA surprised many observers and approved making emergency contraception available to women over 18 without a prescription. The move came nearly two years after the FDA’s reproductive health advisory committee had recommended the change be made. The decision was announced just days before Acting FDA commissioner Andrew C. von Eschenbach, M.D was facing a confirmation vote in the Senate. Senators Patty Murray (D-WA) and Hillary Clinton (D-NY) had announced they would put a "hold" on his confirmation until a decision on emergency contraception had been made.

As pointed out by the reproductive health advisory committee, there are no data to suggest that the product poses any greater risk for women under 18. So the decision to restrict it to 18-year-olds and older still rankled many as being a political, rather than a scientific, decision.
ASRM President Joseph S. Sanfilippo M.D., M.B.A., issued a press statement saying in part, "ASRM has, from the beginning, advocated for the over-the-counter availability of Plan B, and has taken every opportunity to comment to FDA in writing and through its representatives." The ASRM statement also emphasized the importance of using all contraceptives correctly. The statement was picked up in nearly 100 newspapers across the country.

The National Academies’ Human Embryonic Stem Cell Research Advisory Committee Seeks Public Comments; Will Meet in November
The National Academies’ Human Embryonic Stem Cell Research Advisory Committee is set to meet again at a public symposium November 7-8, 2006, at the National Academies in Washington, DC.

The Advisory Committee reviews scientific developments and ethical, legal and policy issues related to human embryonic stem cell research. It also addresses the need for revisions to the Guidelines for Human Embryonic Stem Cell Research and prepares periodic updates to the Guidelines as needed.
In July, I attended the first symposium and spoke about the need for fair compensation for egg donors to SCNT research -- including reimbursement for time lost from work and compensation for pain and physical effort. This is an essential point on which the Guidelines need to be changed; they presently do not allow for donor compensation beyond direct expenses of the donation.
Public comments can be made at the symposium or submitted online a: http://dels.nas.edu/bls/stemcells/input.php.
ASRM members are encouraged to submit their own comments. Let the Advisory Committee know the ways in which you think the Guidelines can be improved or clarified; new scientific, ethical, or legal information that requires the Guidelines to be updated; or about problems your clinic or institution has experienced in relation to embryonic stem cell research (egg or embryo donation).
More information, and the Guidelines themselves, can be found at the National Academies’ Stem Cell Home page: http://dels.nas.edu/bls/stemcells.

ASRM Advocates for Reform of the Medicare Physician Payment Formula
In early September, ASRM worked with the AMA and other medical societies to rally members of the House of Representatives to address the Medicare physician payment cut before Congress adjourns in October. If Congress fails to act, the Medicare sustainable growth rate (SGR) will cut physician payments by 5.1% effective January 1, 2007, with cuts totaling nearly 40% through 2015.

ASRM alerted its members to call their Representatives to urge them to sign a letter to House leadership from Nancy Johnson of Connecticut and Ben Cardin of Maryland.
The Johnson-Cardin letter states that "[t]he average 2006 Medicare rates for paying physicians are about the same as they were in 2001. If the 2007 cut is imposed, then the aggregate payment rates since 2001 will have fallen 20 percent below the government’s conservative measure of inflation for medical practice costs. These projected cuts will destabilize the Medicare program and put at risk all patients’ access to health care."
The SGR is a flawed formula that fails to take into account annual increases in practice costs. Other Medicare providers, such as hospitals, are not subject to the SGR. Payments to these other providers continue to rise: under current law, hospitals will see an increase of more than 3% a year, and payments to Medicare Advantage plans are expected to increase by 7.1% in 2007.
As the United States’ senior population continues to grow, and utilization of Medicare benefits increases, unrealistic payment cuts to physicians will result in reduced access to care. The situation needs to be rectified with a stable and fair payment law for physician services.

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