Fun facts about FDA and third party reproduction
June 4, 2010Carole 1 Comment »Having just returned from a intense two day conference on FDA regulation of sperm, egg and embryo donation, I am full of fun -or at least odd- facts about the convoluted maze of federal regulations designed to protect us from ourselves and our reproductive urges, particularly if we bring more than two to the party.
1. There is no documented scientific evidence that a donated egg or embryo has ever caused transmission of disease from one individual to another. That is a fact, yet we have all these regulations to ensure that egg and embryo donors are not infected with various diseases that interest the FDA, namely HIV, hepatitis B and C, gonorrhea, syphilis, and some others like West Nile virus and Chagas disease. Yes, really. Okay, so better safe than sorry and having all these FDA regulators must be good for the economy.
Semen, or more accurately, the fluid component of semen (and not the sperm cells themselves) can easily transmit infectious disease so having regulations about screening potential sperm donors is a good public health practice.
The FDA requires that potential donors be evaluated on the basis of a medical social history questionnaire, physical exam and blood tests and determined to be either “eligible” or “ineligible” to donate gametes. A donor becomes ineligible if any of the evaluations that are made (answers to the questionnaire, physical exam observations or lab tests) suggest that they are at risk of being infected with a communicable disease or already infected. Eligible donors are expected to have no evidence of high risk behaviors and no reactive blood tests.
2. Gay men who want to create embryos using an egg donor can’t use an anonymous surrogate to carry the embryos. The regulations exclude ineligible donors from using anonymous gestational surrogates. Ineligible donors can however, use a surrogate who is known to them. There doesn’t appear to be a scientific basis for drawing a distinction between anonymous and known donors, at least based on their potential to spread disease. Obviously, an ineligible donor that you know is just as infectious as an ineligible donor you don’t know.
Gay men are automatically made ineligible based on the medical social history questionnaire that asks if they have every had sex with another man. This is the same question that automatically excludes gay men from donating blood. It seems rather discriminatory since straight sex transmits HIV (and other STDs) just as effectively as gay sex so how can having gay sex automatically make someone ineligible to donate?
3. Who is a known donor? This apparently critical definition is not actually defined by the FDA although a person known to the recipient before starting treatment such as a family member, friend or colleague would all apply. The definition gets stretched by some screening agencies and clinics when they introduce the anonymous donor and recipient to each other before starting treatment so they “know” each other and can use the exemptions the FDA regulations have in place for accepting donations from “known” donors. Smells fishy…
4. The FDA requires that the screening facility inform the treating physician that the donor he wants to use is ineligible before he uses gametes or embryos with a recipient, but does not require that the recipient be informed. I asked how this could be if the primary mission of the FDA regulations was to prevent transmission of disease and the recipient, not the physician, was the one at risk? The answer I received is that the FDA considers that an intrusion on medical authority.
To be fair, I imagine that not regulating informed consent in this instance is not a problem for most patients because informed consent is a basic expectation of good medical care that all good doctors practice. It still seems odd to me that the FDA can dictate the 15 specific physical signs that a doctor needs to look for on the donor but draws the line at requiring the physician to inform the recipient that their donor is ineligible and possibly infectious.
5. If the screening/IVF facility really screws up and creates embryos from ineligible donors, embryos can end up in regulatory limbo and never be used. The FDA will cite the facility for noncompliance with the screening regulations that allowed an ineligible donor to be deemed eligible. The FDA will cite the facility if embryos from ineligible donors are created and actually used. Citations for non-compliance can result in escalating levels of regulatory punishment, ranging from hefty fines to closing the facility and even imprisonment of persons responsible for the screw-up.
The embryos can’t be used unless the FDA approves an exemption to the specific regulation that was not followed and gives the facility written permission to go ahead with the embryo transfer. To get an exemption, the facility has to submit a written application for an exemption to convince the FDA that some mitigating factors exist which make the disease risk very small and acceptable compared to the benefit of using the embryos.
Apparently, an expedited decision can be reached in 30-60 days–so those embryos will be frozen in limbo while the FDA deliberates. If the screw-up is a unique precedent setting one- then a ruling may take many months, possibly years of deliberation. I would not be surprised to see a lawsuit against the FDA by a couple who wants to use the embryos anyway, can’t wait for the FDA to finish it’s deliberations and is justifiably upset that the FDA is preventing their family building efforts.Unlike other tissue parts, you can’t just get “replacement embryos” if your embryos are the subject of a “product recall”.
6. Embryos created by sexually intimate partners (who were not subject to the screening requirements because they were planning to create embryos only for their own use when the embryos were created) can subsequently donate their embryos to anyone they please, essentially as known or anonymous sperm and egg donors, without being required to undergo any additional testing. Although the FDA would like it very much if these couples would submit to some secondary screening, they won’t prevent a facility from transferring these embryos. The easing of rules in this case was done to promote embryo donation instead of embryo discarding, dovetailing nicely with the political agenda of our 43rd President, but I digress.
So my foray deep in the forest of FDA regulations was interesting and a little scary, leaving me better informed regarding how to achieve compliance with FDA donor regulations, but more convinced that law-making and sausage-making have a lot in common. Both start out with the best of intentions but can end up producing something messy that may not be good for you.
© 2010, Carole. All rights reserved.
April 2nd, 2013 at 7:13 pm
Carole: As always, an excellent post.
One thing I wanted to mention is that, in reality, no surrogacy arrangement in the U.S. is anonymous. It would just be impractical and would also be ethically questionable. So there is no real practical impact of the FDA’s ban on the use of surrogates by gay men.