Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to email@example.com so that we can defer those challenges. Your health and safety are paramount to us.
Posted 24 January 2013
In July 2012, the conservative-leaning advocacy organization Cause of Action filed a lawsuit against the US Food and Drug Administration (FDA), arguing that the agency's policy requiring potential sperm donors to undergo health testing before being allowed to donate is a violation of constitutional rights.
Now, the group is amending its lawsuit to include even more claims against FDA in the hopes of dismantling the policy.
The suit is something of a cavalcade of constitutional claims, and stems from an issue that doesn't always get a lot of media attention: the regulatory framework of sperm donation.
The case centers around an unnamed woman-"Jane Doe"-who wishes to conceive a child with the assistance and consent of a trusted male friend, Trend Arsenault, a sperm donor whom FDA has been litigating against since 2010. (More information on that case here and here)
FDA's human cell tissue and tissue product (HCT/P) regulations, found at 21 CFR 1271, require that Arsenault undergo "screening and testing… for risk factors for, and clinical evidence of, infection due to relevant communicable disease agents and diseases."
"A donor eligibility determination is required for all donors of cells or tissues used in HCT/Ps, with some exceptions," FDA explains on its website.
Those tests are prohibitively expensive, the Cause of Action lawsuit claims, and are required to be conducted nearly every time a donation occurs. In Arsenault's case, not only did FDA determine that he had not undergone sufficient testing, but also that he had failed to meet manufacturing establishment guidelines for current good manufacturing practices for tissue products. FDA sent Arsenault an FDA Form 483 identifying inspection deficiencies, and later a warning letter ordering him to cease all "operations".
While Cause of Action conceded that FDA's intentions were good-"they're trying to protect the public from communicable diseases," they wrote-the actions are in effect "Stepping between two people who have agreed to have a child," Amber Abbasi, chief counsel for regulatory affairs at Cause of Action, wrote back in July 2012.
"The FDA should not regulate that," Abbasi continued. "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. Essentially, the FDA is trying to define a personal relationship and regulate individuals' intimate decisions. These actions grossly exceed the reach of the FDA's regulatory authority. If unchecked, it could set a dangerous precedent for the future."
The original lawsuit against FDA established six constitutional claims against FDA:
As Regulatory Focusnoted at the time, 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.
While news regarding the case has been slow to emerge, Cause of Action made amendments to its case on 15 January 2013, adding an additional two counts seeking relief.
The first of those claims, count seven, claims that FDA is breaking the Administrative Procedure Act and the Public Health Service Act (PHSA) by attempting to "Regulate or proscribe private, noncommercial acts of conception accomplished by consenting adults through artificial insemination in the privacy of their homes." The group said neither act gives FDA the authority to regulate such acts, and that FDA is thus acting in an "arbitrary" and "capricious" manner and likewise abusing its discretion.
The second claim, count eight, also makes references the Administrative Procedure Act, arguing that the sum total of its claims prove that FDA's actions are "arbitrary and capricious; in excess of statutory authority, jurisdiction and limitations and short of statutory right; an abuse of discretion; without observance of procedure required by law," and are otherwise either illegal or unconstitutional.
Cause of Action's lawsuit seeks a permanent injunction against FDA preventing it from enforcing its authority under 21 CFR 1271, as well as a declaration that the section is unconstitutional, beyond the scope of FDA's regulatory authority, and grant "further relief as the Court deems just and proper."
Regulatory Focus newsletters
All the biggest regulatory news and happenings.