Regulatory Focus™ > News Articles > Warning Letter to Fertility Clinic a Crash Course in Tissue Donation Ethics

Warning Letter to Fertility Clinic a Crash Course in Tissue Donation Ethics

Posted 08 May 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration's (FDA) weekly batch of warning letters are often a cavalcade of depressing observations and alleged violations of every sort. But an April 2013 letter to Olympia Women's Health stands out for an ethical conundrum of sorts involving two patients trying to conceive a child while confronting the risk of transmitting a disease.


Olympia is a Washington-based fertility clinic, according to the company's website. As a site that deals with human cell tissue products, it is governed by FDA tissue regulations under 21 C.F.R. 1271 (Human cells, tissues and cellular and tissue-based products (HCT/Ps)).

Among the requirements of 21 CFR 1271 is part 80(d), which covers the regulations for donor eligibility. The section explains that donors must be tested for "relevant communicable diseases" to mitigate the risk of transmitting them.

HCT/P facilities "must determine the following donors to be ineligible," the section says, and the following list includes "a donor whose specimen tests reactive on a screening test for a communicable disease agent in accordance with 1271.85, except for a donor whose specimen tests reactive on a non-treponemal screening test for syphilis and negative on a specific treponemal confirmatory test."

However, there are some exceptions to this rule, outlined under 21 CFR 1271.90, which allow for reproductive cells or tissue "donated by a sexually intimate partner of the recipient for reproductive use." However, that determination only covers the decision not to screen a donor, and does not overrule 21 CFR 1271.85 if a donor is screened and found to have a communicable disease.

An Ethical Conundrum

And therein lies the ethical conundrum for Olympia. A warning letter sent to the company in April and released on 7 May 2013 explains that FDA investigators found a problem in the company's donor testing procedures.

FDA's overview of the case is thus: An oocyte donor has been classified as "acceptable" despite having tested positive for chlamydia 18 days before the egg was retrieved. Both the donor and her husband reportedly "acknowledged the small risk of infection with Chlamydia and consented to proceed with the procedure."

This presents an interesting problem of sorts. Under 1271.90(a)(2), the donors didn't actually need to undergo donor-eligibility testing. But because they did undergo that testing, and a communicable disease was found, the company violated (allegedly) federal regulations by allowing the fertilization procedure to proceed, even despite the reportedly "small risk of infection."

However, FDA said it is in the practice of allowing such donations to occur provided that they meet the terms of 1271.65(b), which requires the donated tissue product to be properly labeled and stored. That labeling was not done in that case and allegedly in as many as a dozen other cases as well. In addition, a physician must also be notified regarding the outcome of the testing and screening process.

FDA's Warning Letter calls for the company to further address FDA's concerns regarding a lack of justification about the use of oocytes from that particular owner under 21 CFR 1271.155.

The rest of the Warning Letter may be found here.

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