Monday, February 06, 2012

Disseminator


Benjamin Wallace in New York Magazine: The Virgin Father -- a truly fascinating portrait of an offbeat American who's "the father of fifteen children—and counting" primarily through his sperm donation. There are many angles to the story, all of it very, very interesting, but I'm just going to post this excerpt about why FDA got involved in this man's dissemination business:

Although sperm is neither a food nor a drug, the FDA’s Center for Biologics Evaluation and Research regulates those who traffic in it, enforcing frequent and comprehensive tests designed to curb the spread of communicable diseases and genetic disorders. Historically the agency has focused only on traditional sperm banks, not private donors, but Trent was unprecedentedly public about what he was doing. When the FDA first contacted him, he had na├»vely signed a piece of paper confirming that he was “an establishment.” In August 2010, using that as a pretext, the FDA sent three agents to his house, where for several days they interviewed him and copied his records. Trent had by then made 340 donations to some 46 different recipients. The scrutiny was time-consuming and stressful; he didn’t have a lawyer and worried than he might land in prison.

By November, the FDA determined that Trent wasn’t screening for diseases nearly often enough, and it issued its cease-­manufacture order. Trent replied that he wished to contest it. He wasn’t charging money, as he explained, and he was helping people. He knew that he was celibate, that he was disease-free, and that he took extraordinary measures to safeguard his DNA. He considered his relationship with his recipients to be “intimate.” Why should the government regulate what he was doing, when anyone, with who knew what health issues, could walk into a bar and have a one-night stand? A government-accountability public-interest group, Cause of Action, agreed, seeing the FDA action as a ringing example of regulatory overreach, and filed a brief on Trent’s behalf. “We questioned him as to the parameters of his relationship with recipients,” Amber Taylor, the chief counsel for Cause of Action, says. “We took away that he’s a very generous, helpful person who sees people in need who could not have children without some form of assistance, who are often lower income or underserved by the fertility-medicine industry.” Trent is currently awaiting a decision by the FDA on whether to grant him a hearing, and in the meantime, the cease-manufacture order has been suspended.

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