A nonprofit group has filed a lawsuit against the Food and Drug Administration (FDA) for what it calls invasive and prohibitive restrictions on sperm donors.
Cause of Action, a government accountability organization based in Washington, D.C., filed a lawsuit July 2 against the FDA on behalf of an anonymous San Francisco woman who claims the agency’s restrictions on consensual sperm donations infringes her rights.
In the lawsuit, filed in the U.S. District Court of Northern California, Cause of Action argues that the FDA’s regulations “are unconstitutional to the extent that they operate to regulate noncommercial, sexually intimate choices and activity protected by the rights to privacy, bodily integrity and autonomy, liberty, life, due process, and equal protection guaranteed by the First, Fifth, Ninth, and Tenth Amendments to the United States Constitution.”
“We’re involved because this is an instance where a government agency is overstepping its bounds in an area that most people feel is sacrosanct,” said Amber Abbasi, Cause of Action’s chief counsel on regulatory affairs.
The FDA’s policy treats individual donors the same as commercial entities such as a sperm bank or fertility clinic, even if they provide their services for free.
“Human cells and tissues intended for donation, transplantation, or transfer, such as reproductive tissues may be regulated … regardless of whether they are for sale or free of charge,” FDA’s policy states.
The agency exempts people engaged in sexually intimate relationships from the standard, but the FDA’s jurisdiction over what exactly constitutes a “relationship” has drawn the ire of Cause of Action and “Jane Doe,” the pseudonymous plaintiff.
“Doe” is a woman in a same-sex relationship who wants a child, but does not want to deal with the associated fees and red tape.
“A lot of people for many years have gone about these private arrangements,” Abbasi said. “This is something that many people thought was fine until the FDA took this position that anyone who distributes human cells is an establishment that can be regulated.”
The debate began last year with Trent Arsenault, a Bay Area man who donates his sperm free of charge to women.
The FDA slapped Arsenault with a “cease manufacturing” order last year for not following the agency’s regulations and threatened him with a $100,000 fine if he did not comply.
The agency has argued that its policy is meant to reduce the risk of disease transmission to both mothers and their potential children. Many bioethicists and health professionals agree.
"You may know your friend, but it is certainly possible your friend could not be telling you everything about what he does," Mitch Rosen, director of the UCSF Fertility Preservation Center, told the San Francisco Chronicle.
However, Cause of Action and others say that, in addition to privacy concerns, the regulations are exorbitantly expensive for private donors.
“The screenings for sexually transmitted diseases are all very specialized and expensive,” Arsenault said in an interview with the Free Beacon. “It cost me about $1,500 dollars to get a test, so when I was donating four times a month I would have to get four of those tests done.”
He is appealing the order. In the meantime, the agency has allowed him to continue donating. Arsenault has fathered 16 children so far via artificial insemination.
Arsenault, a virgin, said he understands the reasons for the regulations but thinks a compromise is in order.
“My whole lifestyle through being a virgin, it’s pretty unlikely I’d get an STD, but in the general population, you can’t really do that,” he said. “I’d like to see some sort of compromise that isn’t overly regulatory.”
That compromise might soon come about. A bill pending in the California legislature would require a donor to be tested only once if the recipient signed a waiver.
However, Abbasi said, even if the bill passes, the root problem of government overreach would remain.
“What the FDA is saying that, if you have to use artificial insemination, you have to follow the FDA-approved methods,” she said. “It’s a serious infringement on individual rights. It’s the government going into your bedroom and making sure you’re procreating in a government-approved way.”
The FDA declined comment.