Most doctors and clinics are expected to observe the new FDA donor eligibility guidelines, which could be interpreted to prohibit men who have had sex with men in the last five years from making anonymous sperm donations.
The FDA says a donor's sexual orientation serves as the basis for exclusion for anonymous sperm donation, rather than engagement in high-risk sexual behavior (unprotected sex).
By extension, this rule suggests that a heterosexual man who regularly has unprotected sex with multiple partners will be eligible to donate sperm, while a gay man who practices safe-sex in a monogamous relationship will not.
"Fertility clinics across the United States already ensure that donated sperm is safe, regardless of the sexual orientation of the donor," stated Pamela Madsen, Executive Director of The American Fertility Association, the largest, national patient advocacy organization for fertility-related issues. "This FDA rule does not enhance the safety of sperm donations for prospective recipients in any scientifically-meaningful way. It also has the negative effect of singling out gay men as a disease group and perpetuating dangerous, entrenched myths about their bodies as the locus of disease."
Fertility clinics in the United States already test a sperm donor at the time of his initial donation, freeze the sperm for a six-month quarantine, and then test the donor again to be sure there is no new sign of HIV or other infectious diseases.
"The FDA's focus ought to be ensuring that all sperm donations, regardless of the donor's sexual orientation, are properly screened and tested to prevent the unintended transmission of infectious agents," said Dr. Owen Davis, Medical Director for The American Fertility Association and Associate Director of the Center for Reproductive Medicine and Infertility at Cornell University Weill Medical College.
Ironically, the FDA's restriction on gay men's ability to donate sperm comes at a time when more and more gay men and women are choosing to begin their own families. The AFA continues to reach out to this growing community, providing them with alternative family-building information on surrogacy, egg and sperm donation, and legal referrals. In 2005, The AFA will publish a special fact sheet on "Gay and Lesbian Family Building," which will address fertility issues for gay men and women in a thoughtful and substantive way.
"This rule will inhibit rather than encourage donors to speak openly and honestly about their sexual activity and relevant high-risk sexual behavior," added Madsen.
The AFA has already spoken out against other FDA donor eligibility guidelines earlier this year. The new guidelines require donor testing for a number of diseases the FDA identifies as communicable -- ranging from HIV to hepatitis -- 7 days prior to oocyte (egg) retrieval. This 7-day requirement is not based on clinical evidence, has serious ramifications for gamete and embryo donors and recipients, and creates another unnecessary hurdle to those facing reproductive difficulties.
"FDA rules should truly protect rather than randomly exclude a certain segment of donors, without a scientific basis. We urge the FDA to create guidelines that help rather than hinder all people who are trying to build families," added Madsen.