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Policy & Politics
FDA to Implement Guidelines Banning MSM From Donating Sperm Because of Perceived HIV Risk

May 6, 2005

FDA on May 25 will implement new rules banning anonymous sperm donation by any man who has had sex with another man within the past five years because the agency says that such men collectively are more likely to be HIV-positive than other men, Long Island Newsday reports (Taylor, Long Island Newsday, 5/6). The rule is part of FDA's new tissue donation regulations, which were released in May 2004 and will require tissue banks to test donors and donated tissues for HIV, hepatitis B, hepatitis C, syphilis and other diseases and ask donors about their risk factors for such diseases. Chlamydia and gonorrhea testing also will be required for sperm and egg donation. Exceptions to the rules exist for cells or tissues removed from a person and implanted back into them and for sperm and eggs from a person's sexual partner. The rules also include exceptions for repeat anonymous sperm donors (Kaiser Daily HIV/AIDS Report, 5/21/04). In addition, the guidelines would not prevent men who have had male sexual partners within the past five years from donating sperm to a friend or family member, according to the AP/Minneapolis Star Tribune (Crary, AP/Minneapolis Star Tribune, 5/5).

Gay-rights advocates "blasted" the regulations, saying that they are discriminatory and would be difficult to enforce, Newsday reports. New York City Council member Philip Reed (D) said, "First of all, how do they know if you are gay? There are people who have sex with the same sex but don't identify as gay. If I have a feather on my cap and wear a bracelet, am I gay? Now are we supposed to feel that the sperm bank is cleansed and we are now safer?" Ronald Johnson, associate executive director of Gay Men's Health Crisis, said, "It is bad science because it injects a false sense of security and the impression the government is doing something, when in fact they are not taking the more effective way to do proper screening and protection." He added, "We feel that there are adequate and reliable screening procedures that ought to be in place rather than a blanket rule that discriminates against sexually active gay men as a whole category" (Long Island Newsday, 5/6).

Alternative Proposals
Lambda Legal Defense and Education Fund in a letter to FDA has suggested a sperm donor screening procedure that is based on sexual behavior rather than sexual orientation, the AP/Star Tribune reports. The guidelines recommend that any prospective sperm donor be rejected if in the past 12 months they have had unprotected sex with an HIV-positive person, an injection drug user or "an individual of unknown HIV status outside of a monogamous relationship," according to the AP/Star Tribune. Leland Traiman, director of Rainbow Flag Health Services, an Alameda, Calif.-based sperm bank, said that sperm safety also could be determined by testing donors for HIV at the time of donation, freezing the sperm for six months and then testing the donor again six months later.

FDA, ASRM Response
Eleanor Nicoll, a spokesperson for the American Society for Reproductive Medicine, said, "With an anonymous sperm donor, you can't be too careful," adding, "Our concern is for the health of the recipient, not to let more and more people be sperm donors." An FDA spokesperson said that the new rules are "prudent" even if they exclude some MSM who practice safe sex, according to the AP/Star Tribune (AP/Minneapolis Star Tribune, 5/5). An FDA spokesperson also reiterated that the guidelines excluding MSM from anonymous sperm donation are based on "scientific consideration," Newsday reports (Long Island Newsday, 5/6).

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