CoA Brief in Jane Doe v. FDA

Complaint and Civil Cover Sheet – Doe v. Hamburg – Signed

VIDEO: CoA’s Amber Taylor on “Anderson” Discussing Sperm Donor Regulation

.

Amber Taylor visits Anderson Cooper’s daytime show to explain why privacy rights and over regulation are important issues in the debate of sperm donation.

 

VIDEO: CoA’s Amber Taylor on ANDERSON Discussing FDA’s Over Regulation of Trent Arsenault

Amber Taylor with Cause of Action visits Anderson Cooper’s daytime show to explain how the FDA is over regulating Trent Arsenault, a private citizen sperm donor who has been told to “cease manufacture” of his sperm.

 

MSNBC.com: FDA Cracks Down on DIY Sperm Donor

Read the full story here. NBC News

“The Food and Drug administration is working to put an end to a California’ man’s free sperm donation operation. Trent Arsenault, who has provided more than 350 donations and fathered 14 children through them, tells KNTV’s Traci Grant he’s just “helping people in need.”

. . .

Last year, federal Food and Drug Administration officials delivered a letter ordering Arsenault to “cease manufacturing,” or halt his service, because the computer security expert had not followed regulations governing safety precautions for transmission of human cells or tissues through donor clinics.“We have legitimate concerns,” said Shelly Burgess, a spokeswoman for the FDA.But Arsenault was allowed to continue the operation while the agency decided whether to grant him a hearing on the matter, according to his lawyers.The lawyers, who work for the nonprofit legal firm Cause of Action in Washington, D.C., argue that Arsenault shouldn’t be held to clinic sperm donor standards because his contracts with recipients are individual intimate partner arrangements allowed under the law.”

 


 

In the Matter of Trent C. Arsenault

7 Nov 2011 Opposition to CBER Motion to Deny Hearing and for ASJ With Supporting Memo

CoA Stands Up Against Government Regulation of Private Choices

Cause of Action has just filed a brief before the FDA on behalf of Trent Arsenault, a Bay Area man who has been ordered by the federal government to “cease manufacture” of sperm.  Over the last six years, Mr. Arsenault has helped thirteen couples conceive by donating his gametes to them at no cost.  Many of these couples would otherwise have been forced to spend tens of thousands of dollars at a sperm bank without any guarantee of results. Trent does not take any compensation for his services and donates simply out of his desire to help those in his community having trouble conceiving.

Despite this, the FDA last year classified Trent as a “firm” which is a “manufacturer of human cells, tissues, and cellular and tissue-based products.”  As such, the FDA ordered Trent to cease “manufacture” of his gametes unless he complies with regulations that normally apply to sperm banks.  Compliance with these regulations would cost tens of thousands of dollars and be practically impossible for Mr. Arsenault as he does not own, nor operate out of, a laboratory.  Trent has asked for an opportunity to tell his side of the story at a hearing, but the government opposed his request.

Cause of Action has decided to represent Mr. Arsenault because we are outraged at the intrusion of the FDA into the private lives of Trent and the people he helps.  The FDA admits that if Mr. Arsenault was a “sexually intimate partner” with the couples that he helps that he would be beyond their regulation, but they offer no definition of what that term means.  The FDA should not be in the business of deciding who is, and is not, sexually intimate, especially when doing so interferes with private individuals’ ability to start a family.

CoA Stands Up Against Government Regulation of Private Choices

Cause of Action has just filed a brief before the FDA on behalf of Trent Arsenault, a Bay Area man who has been ordered by the federal government to “cease manufacture” of sperm. Over the last six years, Mr. Arsenault has helped thirteen couples conceive by donating his gametes to them at no cost. Many of these couples would otherwise have been forced to spend tens of thousands of dollars at a sperm bank without any guarantee of results. Trent does not take any compensation for his services and donates simply out of his desire to help those in his community having trouble conceiving.

Despite this, the FDA last year classified Trent as a “firm” which is a “manufacturer of human cells, tissues, and cellular and tissue-based products.” As such, the FDA ordered Trent to cease “manufacture” of his gametes unless he complies with regulations that normally apply to sperm banks. Compliance with these regulations would cost tens of thousands of dollars and be practically impossible for Mr. Arsenault as he does not own, nor operate out of, a laboratory. Trent has asked for an opportunity to tell his side of the story at a hearing, but the government opposed his request.

Cause of Action has decided to represent Mr. Arsenault because we are outraged at the intrusion of the FDA into the private lives of Trent and the people he helps. The FDA admits that if Mr. Arsenault was a “sexually intimate partner” with the couples that he helps that he would be beyond their regulation, but they offer no definition of what that term means. The FDA should not be in the business of deciding who is, and is not, sexually intimate, especially when doing so interferes with private individuals’ ability to start a family.

Read Cause of Action’s Brief.