Suing FDA over Directed Sperm Donation?

I guess it’s modestly interesting…

You may have seen the recent news item that a woman, who wants to conceive using a directed sperm donation from a male acquaintance, is suing FDA, presumably, if the media reports are to be believed, because “the Agency” is preventing the donation from happening. She is quoted in some circles as saying that she does not want to be “forced to have intercourse” with the man. In others, it is said that she does not want to pay to have him tested for communicative diseases. It seems like the latter is probably closer to the real issue. At first, I thought she had a compelling argument. After a little digging, I don’t think so.

As I noted in my May 29 post on adult stem cells, FDA regulates human cellular and tissue-related products pretty closely. This includes requirements that “any establishment that performs one or more manufacturing steps” for these products register with FDA, list their products, and satisfy FDA that the steps they take to process the cells or tissues don’t do something to them that would increase the risk that they could harm a recipient of the product.

In the case of donated reproductive cells, FDA requires that establishments test donors of anonymous or directed (emphasis mine) sperm or eggs for several diseases: HIV (types 1 and 2), Hepatitis B and C, syphilis, gonorrhea, chlamydia, and, for sperm, viruses called CMV and HTLV (types I and II). At least some of this testing is subject to the qualification that it is required if the donor and recipient “are not sexually intimate partners.”

If establishments don’t comply, and FDA finds out, FDA may send them a “warning letter,” which is one step short of FDA showing up and padlocking their door and shutting them down. It seems like FDA issues such a warning letter to sperm/egg donation centers every month or two, usually for failure to do the testing.

So it seems to me that nobody is telling this woman she may not have a directed sperm donation from her acquaintance. The reasoning appears to be that, once a third party is involved in handling the sperm (or eggs, the same issues apply), that third party assumes responsibility for preventing the spread of sexually-transmitted disease in the process.

Note that a more elusive issue—whether the donor might have other genetic diseases that pose risks to the eventual offspring—is not raised in this case.

I don’t know for sure how this plaintiff will do in court, but on principle I don’t like her chances.

Of course, I and probably most readers of this blog would reject artificial insemination-donor (AID) overall, on moral grounds, so there would be no issue. And as I read the regs, the same restrictions may not apply in exactly the same way to artificial insemination-husband (AIH).

As I said, minimally interesting. Poorly reported in the press—but they needed a headline, I guess.

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