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
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
Under the new rules, tissue banks will be required to determine donor eligibility by testing for some communicable diseases and screening donors for risk factors, according to an FDA release (FDA release, 5/20). Donors and donated tissue must be tested or screened for HIV, hepatitis B, hepatitis C, syphilis and Creutzfeldt-Jakob disease, which is the human form of mad cow disease. Chlamydia and gonorrhea testing will be required for sperm and egg donation (AP/Las Vegas Sun, 5/21). Semen and stem cells extracted from cord blood will be tested for additional diseases, such as human T-lymphotropic virus (FDA release, 5/20). The regulations enable FDA to implement regulations to test for new diseases -- such as SARS and West Nile virus -- as they emerge. 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, according to the Times-Dispatch (Richmond Times-Dispatch, 5/21).
The new rules will require tissue banks to ask donors a series of questions to determine their risk factors for particular diseases, including HIV. People who have injected drugs in the past five years and men who have had sex with men in the past five years will be prohibited from making donations. If the donor is deceased, a family member or doctor who is familiar with the person's medical history must answer the questions on behalf of the deceased, according to the New York Times. New York state already bars MSM from donating sperm, and most sperm banks have similar regulations, according to the Times. In addition, most sperm banks freeze and quarantine sperm donations for six months, testing the donor for HIV at the beginning and end of the period, according to American Association of Tissue Banks Chair Russ Bierbaum (Harris, New York Times, 5/20). Under the new rules, MSM who are barred from anonymous sperm donation still will be allowed to donate to friends or family members who know the donor and his medical history (Washington Times, 5/21). FDA over the next three months will take public comment on the new rules, which are scheduled to take effect next year. In addition, the agency later this year is expected to adopt additional rules governing the handling, processing and storing of tissues, Dr. Jesse Goodman, director of biologics evaluation and research at FDA, said (Richmond Times-Dispatch, 5/21).
"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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