FDA Citizen's Petition: The Need For Sperm Bank Regulation

01/12/2017 05:55 pm ET | Updated Jan 13, 2017

We just filed a “Citizen’s Petition” to the FDA, and it’s now available for people to add comments. Please, add your comments, as the more we get, the better our chances of accomplishing something (anything….even a further conversation with the FDA would be considered success). https://www.regulations.gov/docket?D=FDA-2017-P-0052

“Because the FDA currently mandates minimal medical testing of sperm and egg donors (no other regulation exists), we request that the commissioner of the FDA look into the state of affairs surrounding the sperm donation industry, and then develop the appropriate and much needed regulation/oversight.”

From my FDA contact:

“Good Morning Wendy, I’ve attached your acknowledgement receipt for the petition. Its docket number is officially FDA-2017-P-0052. You may view or comment on the petition through www.regulations.gov here is the link to your petition: https://www.regulations.gov/searchResults… I have sent the petition to the FDA’s Center for Biologics Evaluation and Research (CBER). Per regulation the center has 180 days to respond to you about this petition. That response may be a decision or an interim response. We won’t likely receive an update before that time unless the center has questions for you. In that case, they will contact you directly.”

A few initial public comments:

“Our cryobank has been unable or unwilling to locate our “identity release” donor for 6 months now, despite all requirements/paperwork being in order, and does not return phone calls or emails regarding the status of our request to contact the donor. However, with DNA testing we were able to locate the donor ourselves, only to learn that some of the original information we were provided by the cryobank was incorrect, including identity release status, ethnicity/religion, college information, SAT scores, and certain health information. This industry needs to be regulated so that donor information is factually correct and that the cryobanks are being forthright and honest in their dealings with clients.”
“The United States is one of the only developed countries on earth that is lacking crucial regulation and oversight of the artificial reproduction industry. There is ample research supporting the negative effects that this lack of regulation continues to cause. The FDA has a responsibility to put common sense regulations in place to ensure the safe and ethical creation of human lives by donor conception.”
“I strongly support additional review of the donor gamete industry. I believe the FDA should engage in further investigation of the business of egg, sperm, and embryo donation as a basis for developing further regulation and oversight. As an academic who has studied and written articles and books about the fertility industry, I strongly urge you to undertake additional review. Thank you.​”
​“I reported to the sperm bank that my child was diagnosed with cancer (lymphoma/leukemia) the same week of his diagnosis and provided proof, so they could report it back to the donor and to the other families who had used the same donor. Almost two years later, none of the 11 families I am in contact with have been notified about my son’s condition.”

And I also submitted a comment:

Here is some recent input from families who used California Cryobank  (from the Donor Sibling Registry Secret Facebook page, January 2017). This information illustrates the dishonest manner in which sperm banks (California Cryobank is not unique in this respect) disseminate information about limits on numbers of offspring for any one sperm donor:
“They told me in 2011 it was limited to 20 family units but they are now saying it has increased to between 25 and 30 family units.” “In 2011 CCB also told me that they limit families of open id donors to 20 and anonymous donors to 25. ” “Back in 2004 I was told that each donor had 10 vials and that was it. ” “When I used CCB in 1999 they told me limited to 30 families- as of right now there are 30 kids. “In about 1990 they told me ten. I guess it just depends on who answers the phone!” “In 1991 they said 1 or 2 births was the limit.” “In 2005 we were told the limit per donor was ten families ” “In 2010, when we chose our CCB donor, we were told 10 families max.”
Note: When a prospective donor called CCB last summer and asked this question: “What is the maximum number of children that you allow per donor? California Cryobank told the prospective donor, “12 to 15 family units.”

CONVERSATIONS

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