Policy & Politics
New FDA Tissue Transplant Rules Require STD Testing for Sperm, Egg Donation, Bar MSM, Injection Drug Users From Donating
May 21, 2004
Tissue banks must 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, according to new FDA tissue donation regulations released on Thursday, the AP/Las Vegas Sun reports (Neergaard, AP/Las Vegas Sun, 5/21). Although donated blood and organs have been regulated for a long time, other donated tissue -- including skin, ligaments, umbilical cord blood, sperm and eggs -- have been subject to less strict oversight, according to the AP/Atlanta Journal-Constitution (Neergaard/McNaughton, AP/Atlanta-Journal Constitution, 5/21). The transmission of communicable diseases through tissue and bone transplants is considered rare but can happen, according to the Richmond Times-Dispatch (Hostetler, Richmond Times-Dispatch, 5/21). The new rules are part of a five-year FDA effort to expand its oversight of the growing tissue bank industry, according to the Washington Times (Richardson, Washington Times, 5/21). The rules will regulate semen, eggs, embryos, cord blood, cellular therapies and other "innovative products" and will "exten[d] the scope of protection against additional communicable diseases," according to an FDA statement (Fox, Reuters, 5/20).
"This rule is a major step toward ensuring that tissue contaminated with life-threatening pathogens is not transplanted into unsuspecting patients," Sen. Susan Collins (R-Maine), who led several hearings on the issue, said, adding that she "remain[s] perplexed by the FDA's repeated and unacceptable delays in implementing this rule" (Reuters, 5/20). MSM advocacy groups denounced the risk screening regulation, Agence France-Presse reports. National Gay and Lesbian Task Force spokesperson Roberta Sklar said that the regulations are "unscientific" because some tests can determine HIV status within 72 hours (Agence France-Presse, 5/20). "It's one thing to base these rules on legitimate scientific concerns, but it's another to reinforce baseless stereotypes," NGLTF Executive Director Matt Foreman said (New York Times, 5/20). "HIV affects every part of our nation's population, and the FDA needs to realize that fact and stop treating gay men as the only people who contract HIV," Lambda Legal Defense Fund Executive Director Kevin Cathcart said. "I do understand their concern and the desire of everyone to be donors," Goodman said, adding, "We like to have a system in place where we don't just rely on one thing." Although there have been "tremendous improvements in laboratory testing, they're not foolproof," Goodman said, adding, "For that reason, we routinely exclude populations where sound scientific evidence shows that there could be a risk to the person receiving the donation" (Washington Times, 5/21).
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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.