Regulatory Focus™ > News Articles > Lawsuit: FDA Tissue Donation Regulations 'Unconstitutional'

Lawsuit: FDA Tissue Donation Regulations 'Unconstitutional'

Posted 10 July 2012 | By Alexander Gaffney, RAC 

A woman is suing the US Food and Drug Administration (FDA) over its policy requiring potential sperm donors to undergo health testing before being allowed to donate, calling the regulations a violation of her constitutional rights.

At issue for the woman-an Oakland, California resident known only as "Jane Doe" in the court filings-is whether she can use a trusted male friend as a sperm donor so she may start a family with her female partner without the interference of the federal government. The tests are reportedly expensive and are required to be conducted within a week of the donated tissue being donated.

"If there are donors like this who are not charging as a service, and not serving as a business, the FDA should not be intervening," said Amber Abbasi, chief counsel for regulatory affairs at Cause of Action-an advocacy group who filed suit on behalf of the anonymous woman.

Abassi's group argues the matter is partially an issue of equity: heterosexual couples conceiving through more orthodox means face the same hypothetical risks-spreading sexually-transmitted diseases, infection or passing a hereditary disease to future child-yet those couples are not subject to the same testing as are homosexual couples.

"We don't think the FDA's intentions are bad-they are trying to protect the public from communicable diseases-but this is literally stepping between two people who have agreed to have a child; the FDA should not regulate that," added Abbasi.

"Essentially, the FDA is trying to define a personal relationship and regulate individuals' intimate decisions," said Abbasi. "These actions grossly exceed the reach of the FDA's regulatory authority. If unchecked, it could set a dangerous precedent for the future."

Lawsuit Calls Regulations "Unconstitutional"

The lawsuit strikes FDA's human cell tissue and tissue-based product (HCT/P) regulations, which regulate not only the procedures relating to the transfer of tissue products, but also quality practices at the donor facilities. The lawsuit is looking to validate what it calls Jane Doe's fifth amendment due process rights against "federal government intrusion" and her ninth amendment right against infringement of her un-enumerated rights-in this case, her right to procreate.

"The government cannot prescribe regulations that burden Ms. DOE's fundamental right to procreate unless doing so is necessary to achieve an overriding government purpose," writes Cause of Action in its lawsuit. "By prohibiting or severely restricting individual donors from freely donating semen for artificial insemination to consenting adult women even though doing so is not necessary to achieve a compelling government purpose, 21 C.F.R. pt. 1271 impermissibly burdens the procreative liberty of Ms. DOE, other similarly situated women, and male donors with whom they seek to conceive children."

Depending on a judge's response to the brief, the case-Doe v. Hamburg-could lead to the regulation being slightly curtailed or thrown out entirely as unconstitutional. The legal brief requests the judge to "Declare that 21 C.P.R. pt. 1271 is unconstitutional to the extent it purports to prevent individuals from donating semen for artificial insemination directly to other individuals on a private, uncompensated basis," and further requests a carve-out to prevent FDA from enforcing the HCT/P regulations in Jane Doe's case and in other similar cases.  

Read more:

(h/t) San Francisco Chronicle - Woman sues FDA for right to use donor's free sperm

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