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.
