Please comment on our FDA Citizen's Petition, "Request that the FDA look into the state of affairs surrounding the sperm donation industry, and then develop the appropriate and much needed regulation/oversight." A pdf of the Petition.
1/4/17-7/4/17: We 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
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.
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."
One example of a comment from a doctor/donor conceived person.
The myth of donor anonymity is perpetuated by researchers:
12/2016: This recent article published in the Journal of Law and the Biosciences called: Sperm Donor Anonymity and Compensation: An Experiement With American Sperm Donors illustrates that fact that the US sperm banking industry is still not properly educating prospective donors and parents about the myth of anonymity. With DNA testing, Google and social media, anonymity is a thing of the past. Sperm banks (and egg clinics) need to stop the fallacy of selling "anonymous" donors, and the "experts" need to stop perpetuating this idea. Donor conceived people have been locating their donors via DNA testing since 2005 (see New Scientist Magazine 11/3/2005)- so this is not new. This published "study" was conducted in partnership with a sperm bank who profits more from offering anonymous donors. Communication with their donors about anonymity had already taken place. How was this major conflict of interest acceptable to the Journal of Law and Biosciences? In response to the article, Harvard Law published my blog contribution, and the link to my HuffPo response blog ("10 Things").
After 11 years, the industry is finally catching on. A letter from the Editor-in-Chief of Human Reproduction: "Due to genetic testing donor anonymity does no longer exist":
Many thousands of people worldwide have been conceived with donor gametes but not all parents tell their children of their origin. Genetic testing will make this impossible. Over three million people have already used direct-to-consumer genetic testing. The rapidly increasing availability of cheaper and more detailed tests poses numerous challenges to the current practice of sperm and egg donation: 1. Whether they are donating in a country that practices anonymous donation or not, donors should be informed that their anonymity is no longer guaranteed, as they may be traced if their DNA, or that of a relative, is added to a database. 2. Donor-conceived adults who have not been informed of their status may find out that they are donor-conceived. 3. Parents using donor conception need to be fully informed that their children’s DNA will identify that they are not the biological parents and they should be encouraged to disclose the use of donor gametes to their children. All parties concerned must be aware that, in 2016, donor anonymity has ceased to exist. -JLH (Hans) Evers, Editor-in-Chief Human Reproduction
Where around the world is donor anonymity banned?
Austria, Finland, Germany, The Netherlands, New South Wales, New Zealand, Norway, Sweden, Switzerland, UK, Victoria and Western Australia.
Court reaffirms: no anonymity rights for sperm donors......IN GERMANY. "A Hanover court on Monday ruled that a child's right to know about their lineage was more important than a sperm donor’s right to privacy, reaffirming a high court ruling from last year."
The media and other industry "experts" frequently report that ending donor anonymity will automatically result in a drop in donor numbers. Quite to the contrary, there has been a 10 fold increase in the number of sperm donors AFTER removal of anonymity in the state of NSW, Australia. Published in the Herald Sun on Sunday 22nd May 2016:
2016: A new paper has just been published in the Journal of Law and Medicine on the effect of removing donor anonymity on sperm donor numbers in Australia: Does the removal of anonymity reduce the number os sperm donors in Australia?
From one of the authors: Now that we have data that the UK and Australia were not adversely affected by removing anonymity, hopefully the USA will follow suit. Especially seeing as though DNA makes any guarantee of anonymity null and void, it is unethical that clinics still offer it.
The HFEA in the UK only has numbers through 2013. (Are they still keeping track?) We can see that the numbers of UK donors have gone up since the ending of anonymity, thus reversing a three year decline.
|Year||Sperm Donors||Egg Donors||Year||Sperm Donors||Egg Donors|
Wendy's Huffington Post Blog
In the News
2/17: NBC News Colorado: Sperm Donor's Medical History- California Cryobank
2/17: NBC News Atlanta: Sperm For Sale- Xytex
11/16: Canadian Medical Association Journal: Switched before Birth, "...why is it wrong when it happens in a hospital by accident, but ok when doctors are paid to do it? That is the question on the minds of so-called 'donor offspring' - people created through the eggs or sperm of individuals they will never know".
- 9/16: IndyStar: Another doctor caught using his own sperm more than 50 times.
- International Business Times : "Although Cline’s personal donations may be considered unethical by many, it’s a practice that wasn’t all that uncommon for fertility clinics before the 1990s.Director and co-founder of Colorado-based Donor Sibling Registry, Wendy Kramer, told the IndyStar she always advises people conceived through the help of a sperm bank before 1990 to check their mother’s fertility doctor first when searching for their biological father. The website helps connects parents, donors and offspring, and according to Kramer, checking a mother's fertility doctor is a crucial first step in determining the biological father for most children born before 1990."
- 8/16: Law.com: Prolific Sperm Donor Was a Schizophrenic, Not a Neuroscientist, Leading to Spate of Suits
- 7/16: NY Times: Sperm Banks Accused of Losing Samples and Lying about Donors
- 2/16: Victoria, Australia: New Law Gives All Donor-Conceived Victorians The Right To Know Their Heritage
- 12/15: EC Gynaecology Commentary: The Need For Comprehensive Genetic Testing of Gamete Donors
- 12/15: Malta: Commissioner for Children Helen D'Amato said egg and sperm donation should not be permitted.
- 5/15: Wendy's Guest Blog on International Children's Rights Institute website.
- 4/15: Manhattan Cryobank Gifts $100,000 to the American Society of Reproductive Medicine
- 4/15: CBC Radio Interview
- 4/15: Radio Canada Interview Live Link: http://www.rcinet.ca/en/2015/04/10/mistakes-illustrate-need-to-regulate-sperm-banks/
- 4/15: Couple Sues Xytex: A Canadian couple is suing a Georgia sperm bank, saying that the donor the company provided for them turned out to be a schizophrenic who has a criminal record and whose photo was doctored to make him look more attractive. The Toronto Star: Sperm donor shortage forces Canadians to look to US US Sperm Bank Admits It Doesn't Verify Donor Information
- 3/15: London Times: Sperm donation, a lucrative and growing industry
- 10/14: Washington Post: White woman sues sperm bank after she mistakenly gets black donor's sperm.
- 9/14: Chicago Tribune: Midwest Sperm Bank Mixup The Today Show
- 7/14: No Sperm Shortage in the UK
Recent reports that sperm donation in Britain is still in a critical state have been much exaggerated. Donors and sperm samples are in good supply, reports the London Sperm Bank
- 4/14: The Salt Lake Tribune: University of Utah says sorry for sperm mix-up; family not happy
- 4/14: Fox News: It's time for states to outlaw anonymous sperm, ova donations
- 1/14: FoxNews.com: More children born from sperm donors seeking out genetic family
- 1/14: Guest Blog: An Adoptee's Reaction to MTV's Generation Cryo
- 1/14: TX Family Discovers Switched Sperm Donor A family discovers that they were the victims of a sample switch at a Utah fertility clinic.
- 8/13: The Age, Victoria, AU: State law change to help children find donor parent
- 8/13: CBC News: 4 women received wrong sperm. "In an agreed statement of facts, five women were involved in four artificial inseminations provided by Barwin between 1986 and 2007 and in all four cases DNA tests confirmed the women received the wrong sperm."
- 9/12: BBC News: Denmark tightens sperm donor law after NF1 transmissions
- 9/12 Daily Mail: Danish sperm donor passes rare genetic disorder
The BBC News and Daily Mail articles are referencing an earlier story, originally reported by DSR members (see the 5/11 Copenhagen Post article on our Medical Issues page). The interesting thing about this story is that this donor is also a California Cryobank donor. We regularly hear stories about sperm donors passing along medical and genetic issues to children here in the US, but no regulation is ever initiated.
- 5/12: BioNews: A call by the Donor Sibling Registry to stop using the ﬁgures of 30,000-60,000 US sperm donor births
- 3/12: The Sydney Morning Herald: We can't keep them in the dark
- 10/11: Salon: Are Sperm Banks Unethical?
- 10/11: NBC Dallas: Some Call for Regulation of Sperm Banks
- 10/11: Colorado Public Radio: 'Donor Unknown': One Girl's Quest to Find Her Father (link to website)
Audio interview with Wendy Kramer
- 10/11: New York Times: Getting to Know a Sperm-Donor Dad
- 10/11: AlterNet: One Man Fathering 150 Children? Why Sperm Banks May Be Unethical
- 8/11: USC Reporting on Health: The Secrets of Fertopolis: Should Sperm and Egg Donors Have to Disclose Their Identities?
- 4/11: Infertility & Reproductive News: Impact of Egg, Sperm, and Embryo Donor Conception on Families
- 3/11: The Center for Bioethics and Human Dignity: Regulation (or Lack Thereof) of Assisted Reproductive Technologies in the U.S. and Abroad
Among developed nations, the U.S. assisted reproduction or fertility industry is one of the least regulated. This has led to a reproductive free-for-all. Any technological means, regardless of the medical and ethical consequences, can be utilized in the pursuit of parenthood if the price is right.
- 1/11: BioNews: Paying gamete and embryo donors: what are the right principles?
- 10/10: The Guardian: Shortage? What shortage? How the sperm donor debate missed its mark
- 2010: The Columbia Science and Technology Law Review: The Regulation of Genetic Aspects of Donated Reproductive Tissue--The Need for Federal Regulation
- 5/09: BioNews: The case for comprehensive medical testing of gamete donors
- 4/09: International Journal of Law, Policy and the Family: Donor-Conceived People's Access to Genetic and Biographical History: An Analysis of Provisions in Different Jurisdictions Permitting Disclosure of Donor Identity
- 4/09: Law.com: Sperm Banks Can Be Sued Under Product Liability Laws, Federal Judge Rules
- Fall 08: Human Life Review: “Donor Offspring” Redefining Family
- 3/08: Wendy Kramer's Speech: DONOR SIBLING REGISTRY: Educating, Connecting and Supporting Donor Families
I believe that it is of paramount importance that this industry examine and address the issues of educating, connecting, and supporting donor families as well as the necessity of more accurate record keeping and accountability.
- 2/06: U.S. News & World Report: Who's Your Daddy?
- Marilyn Huff: What's the Limit of Offspring per Donor?
A commentary on the ASRM's guidelines for the number of offspring per donor.
- 8/88: Princeton University: Artificial Insemination: Practice in the United States: Summary of a 1987 Survey
This is the only survey on US sperm banks to date. It erroneously stated that there were 30,000 donor-offspring born each year in the US. The same number that's used today, 25 years later.
Other Relevant Articles
Here are some other articles on the law, the ethics, the comparisons to adoption, the need for regulation, and the nuts and bolts of donor conception. Issues we should all ponder!
- 12/11: BioNews: Of family and ﬁnance: Israeli citizens without rights and HFEA remuneration
- 9/10: The Globe and Mail: Doctor sued over allegedly mixing up sperm samples
- 7/10: BioNews: 'My Daddy's Name is Donor': Read with caution!
- 2009: Medicine and Law: Donation of Eggs in Assisted Reproduction and Informed Consent
- 12/09: Genomics Law Report: Reproductive Genetic Screening: More Questions Than Answers
- 11/09: BioNews: Children's human rights and assisted human reproduction
- 6/09: National Review: Scrambled Ethics
- 2/09: Adoption Institute: Old Lessons For a New World: Applying Adoption Research and Experience to Assisted Reproductive Technology
- 1/09: ASRM Ethics Committee: Interests, obligations, and rights of the donor in gamete donation
- 12/08: The Wall Street Journal: Ova Time: Women Line Up To Donate Eggs -- for Money
- 6/08: Medical News Today: Donor Offspring May Feel Betrayal, Anger: Study
- 6/08: ADVANCE: Conceivable Truths
- 4/08: Naomi Cahn: Necessary Subjects: The Need for a Mandatory National Donor Gamete Registry
- 11/07: Center for Genetics and Society: It’s Time for an Egg Donor Registry and Long-term Follow-up
- 2007: Thomas K. Sylvester, Yale Law School: The Case Against Sperm Donor Anonymity
- 2007: CNN: States urged to open adoption records
- 2007: Best Practice & Research: Donor gametes: anonymous or identiﬁed?
- 3/07: Manchester Evening News: Men still donating sperm
- 4/07: American Fertility Association Newsletter: DNA And The Exploding Myth Of Donor Anonymity
- 11/05: NewScientist.com: Anonymous sperm donor traced on internet
- The Sperm Bank of California: Research (link to research)
NY State Law
NYCRR Title 10 PART 52-8.9 Required records.
(a) Reproductive tissue bank records shall be open to inspection by the department and shall be kept for at least seven years after release of reproductive tissue for artificial inseminations or assisted reproductive procedures not resulting in a live birth, and 25 years for inseminations or assisted reproductive procedures known to have resulted in a live birth. For all donated reproductive tissue, the donor's name, address, and any other information which would directly or indirectly identify the donor shall not be disclosed or released by the reproductive tissue bank to any person or entity, except upon the written informed consent of the donor, or except to authorized employees of the department or as permitted by law. The recipient's name, address, and any other information which would directly or indirectly identify the recipient shall not be disclosed or released by the insemination/ implantation site to any person or entity, except upon the written informed consent of the recipient, or except to authorized employees of the department, or as permitted by law.
(b) In addition to the recordkeeping requirements of section 52-2.9(c) of this Part, each reproductive tissue bank shall maintain applicable donor/client-depositor records which include:
(1) for donors, pertinent family history of any genetic disorders;
(2) documentation of donor and client-depositor written informed consent;
(3) for semen donors, outcome of any prior artificial insemination or other assisted reproductive procedures, if known, including number of successful pregnancies, if any, and any reports from insemination/ implantation sites which would affect the donor's acceptability; and
(4) documented approval of the reproductive tissue bank director, or his/her designee, of the acceptability of the donor.
(c) In addition to the recordkeeping requirements of section 52-2.9(e) and (f) of this Part, each reproductive tissue bank shall maintain applicable records which include:
(1) donor's identification code or client-depositor's name;
(2) for semen donations, documentation of laboratory cryosensitivity testing, and, if performed, results of viability checks after thawing and during storage, if any;
(3) the name of the insemination/implantation site, the physician or other person authorized by law to perform artificial insemination or assisted reproductive procedures, and/or receive reproductive tissue, and the name of the person communicating the order for distribution of the tissue;
(4) the recipient's name, if the name has been provided to the reproductive tissue bank with her informed consent, or the recipient's identification code, if used;
(5) documentation of training, certification, licensure, if required by law, and continuing education for each staff member; and
(6) any adverse outcomes, including infectious diseases in recipients or their offspring and genetic defects in offspring, which shall be reported to the donors if there is any possibility that the donor's reproductive tissue contributed to the adverse outcome.
(d) The following records shall be kept, separate from the recipient's records, by
an insemination/implantation site for each insemination or assisted reproductive procedure performed:
(1) donor's identification code or name, if the reproductive tissue originates from a client-depositor;
(2) evidence that reproductive tissue from donors and/or client-depositors has been obtained from a reproductive tissue bank licensed pursuant to Subpart 52-2 of this Part;
(3) disposition of the reproductive tissue, including, but not limited to, the name or identification code of the recipient, destruction logs, and autoclaving or incineration records;
(4) the name and signature of the ordering physician or other person authorized by law to order issuance of the reproductive tissue;
(5) results of sperm viability checks, if performed; and
(6) signature of the person receiving the sample and condition of the sample upon receipt.
(e) The insemination/implantation site shall document the outcome of the artificial insemination or assisted reproductive procedure, including, but not limited to, any known adverse outcome in the infant or infectious disease in the recipient, as well as any known successful pregnancies. This information shall also be reported to the reproductive tissue bank releasing the tissue, even if the reproductive tissue bank is the same entity as the insemination/ implantation site.
Please browse our "News and Videos" pages (for members only) as there have been many news stories over the past decade addressing the many issues within the reproductive medicine industry.