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US FDA issues new rule on donated tissues and cells
The US Food and Drug Administration (FDA) has introduced new regulations to help prevent the transmission of disease through donated tissues and cells. The new rule, effective in May 2005, will require that virtually all donated tissues and cells, including sperm and stem cells, now must be screened for diseases such as AIDS, Creutzfeldt-Jakob disease (CJD, the human form of mad-cow disease), and SARS. Currently, the FDA only requires that some donated tissues, such as skin and eye tissue, be screened for hepatitis and AIDS. However, there have been hundreds of lawsuits on behalf of individuals who have been harmed or died from infections caused by contaminated tissue brought against the FDA and companies that sell tissue. Additionally, the number of tissue transplants has grown to more than a million a year in the US. Therefore the FDA has increased screening to include new infectious agents as well as added new types of tissue to the list of those being screened, in order to better protect tissue recipients.
The rule also includes tighter restrictions on who may be suitable donors. Individuals who lived in Britain during the 1980s and height of the mad cow disease epidemic will not be able to donate certain tissues as they are seen to be at a higher risk of developing CJD. Controversially, homosexual men who admit to having had sex with another man in the past five years will not be able to donate sperm if it is to be used by strangers. They can donate for use by family members or friends. Restrictions of this type have been in place in some states but now will apply to the entire US. While officials state that this will further reduce the possibility of transmitting HIV to the tissue recipient, gay activist groups claim that this is bigotry and ignores scientific research showing that there are tests that can adequately screen for HIV. “There is a 72 hour test which would provide information as to whether a person was HIV positive, we know that even the International Red Cross accepts blood from men who have sex with men,” Roberta Sklar, of the National Gay and Lesbian Taskforce, has stated to the press. However, the FDA maintains that the suitability of some individuals to donate may need to be judged based on their lifestyle choices