ASRM Washington Wire

Congress Gets Busy Just Before Holidays
Just as millions of Americans wait until the last minute to do their holiday shopping, their government also excels at procrastination. Rushing to finish their business before the Christmas recess, Congress waited until late December to finish several important items.

First they passed a Medicare bill that replaced a 10% cut in physician payment scheduled for January 1, 2008 with a 0.5% increase. While this is good news, without further action, the respite will be brief. The cut is now scheduled to take effect on July 1, 2008. The American Medical Association which has been leading the fight on this issue is already hard at work seeking a permanent fix. This bill also extended the State Children’s Health Insurance Program, without an increase, through March 2009.
Congress and the President also managed to cut a deal on federal spending for the 2008 Fiscal Year, which actually started in October.
NIH got an appropriation of $29.229 billion, an increase of $329 million or 1.1% over FY 2007. CDC got an increase of $110 million for a total of $6.38 billion.
The Agency for Healthcare Research and Quality (AHRQ) would get $335 million, an increase of $16 million. This includes $30 million on clinical effectiveness research, double the 2007 figure.
Federal family planning through the Title X program received a $22 million increase. The current abstinence-only education program is extended through June 30, 2008 and is funded at the FY 2007 level of $113 million.

FDA Seeks Enforcement of So-Called “Bioidentical” Compounds
In early January, the U.S. Food and Drug Administration (FDA) announced that it had sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bioidentical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency. FDA is concerned that unfounded claims like these mislead women and health care professionals.

The pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA approved drug and has not been proven safe and effective for any use) are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer's disease, stroke, and various forms of cancer.

FDA is concerned that the claims for safety, effectiveness, and superiority that these pharmacy operations tout are misleading patients, as well as doctors and other health care professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible. The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.

FDA also responded yesterday to a citizen petition from Wyeth, Madison, NJ, requesting regulatory action against compounding pharmacy operations that produce compounded "BHRT" drugs. Other stakeholders, including ASRM and other health care providers and consumer groups, have also raised concerns about "BHRT" drugs.

“Behind-the-Counter” Drugs?
ASRM testified in a FDA public hearing on creating a new category of “behind the counter” drugs. We expressed our concern that such a category could easily be misused to make reproductive drugs more difficult for patients to access. Their access could be jeopardized either by federal policies made for non-medical reasons, such as those for emergency contraception, or by the refusal of individual pharmacists to make products available.

Stem Cells

The pre-Thanksgiving media was dominated by the news that scientists had been able to reprogram adult cells into embryonic stem cell-like tissues, and induced those tissues into becoming different specialized tissues themselves. Should others be able to replicate this work, then the need to use eggs or embryos for regenerative medicine would be dramatically reduced. The week prior, a team from Oregon announced they had used SCNT in non-human primates to generate ES cell lines. In January, researchers from Advanced Cell Technology announced they had successfully generated stem cell lines. All of these developments could impact the policy debate about stem cell research.
In June 2007, the House passed S. 5, the Stem Cell Research Enhancement Act, and sent it to the President. Unfortunately, the President vetoed the bill, and it is generally thought that the votes are not there to override the veto. S. 5 would have lifted the President’s restrictions on funding embryonic stem cell research and allowed federally funded scientists to work with stem cell lines derived from IVF-created embryos which are no longer needed clinically by patients.

Colorado Ballot Measure for Embryo Rights
In Colorado, proponents recently won a case allowing them to move forward with a ballot measure to grant full constitutional rights in the state to fertilized eggs, embryos, and fetuses. If they can get enough signatures, the measure will be on the ballot in November. There are some reports that similar efforts will be mounted in as many as half a dozen other states. These measures raise very serious issues for reproductive medicine-from contraception to ART. ASRM is paying close attention to these developments and will
oppose them strongly.

Return to Washington Wire Archive

By accessing and using the ASRM Web Site, you agree to be bound by
the ASRM Web Site Terms and Conditions of Use.

View the ASRM Non Discrimination Policy

Listed on Infertility Resources
Developed and hosted by Internet Health Resources