The Food and Drug Administration has sent a letter to several IVF clinics reminding them that administering allogeneic human cells - specifically lymphocyte immune therapy (LIT) as a therapy for recurrent miscarriage falls under FDA jurisdiction. The FDA letter states, "until such time as there is an approved Biologics License Application for the product, administration of such cells or cellular products in humans can only be performed as part of clinical investigations, and then only if there is an Investigational New Drug (IND) in effect."

A copy of the letter can be obtained in several places on the FDA web site. The direct link is http://www.fda.gov/cber/ltr/lit013002.htm

Bush Budget Mixed For Health Care Issues

President Bush's proposed budget for FY '03 is a mixed bag for health care concerns. On the positive side it contains an increase of nearly 16% or $3.7 billion for the NIH. This would bring total NIH funding to $27.3 billion. This fulfills a Bush campaign pledge to continue the effort to double NIH funding.

Even at the NIH, the bulk of the increase is related to bio-terrorism. Elsewhere in HHS health funding, most programs not relating to bio-terrorism are either flat funded or reduced. Reflecting its policy agenda, the Bush administration does call for an increase in funds for abstinence education.

There are also press reports, but no official details, on extending the CHIPS pediatric health insurance program to unborn children. We will monitor this for its possible impact on reproductive health issues, particularly contraception and infertility therapy.

Senate Judiciary Committee Holds Cloning Hearing

The Senate Judiciary Committee held a cloning hearing yesterday. Witnesses included the chairs of the NAS panel and the California panel that both recommended a prohibition on reproductive cloning, but regulated use of Somatic Cell Nuclear Transfer (SCNT) for research and, perhaps, therapeutic use. They also heard from a spinal cord patient who urged them to allow research to continue, as well two proponents of a broad ban similar to what passed in the House.

ASRM continues to work to oppose a broad cloning bill. Members of the ASRM Executive Committee, who met in Washington for their winter meeting, spent considerable time visiting with Senate offices to explain the ASRM stance and the science and ethics that led to our stance.