Unregulated fertility technologies are being used to create babies




Germline changes with largely untested tech seem like a bad bet if they can be avoided.

Non-germline, worst you can do is ruin kiddo’s life (hardly a good outcome; but one plenty of parents roll the dice on without the benefit of exotic techniques); but if a germline mod turns out to go poorly you are stuck either hoping that you can patch the regression a generation down the line, move the carrier not to pass it on by means that hopefully won’t involve the more uncomfortably retro options; or end up having added a genetic disease to the collection; which is kind of a shabby move.


You’re thinking devices and drugs. Drugs can get approval for manufacturing and marketing for particular therapies. But compounding pharmacies don’t require approvals to make drugs when hey make them by prescription. Devices are not approved, they are cleared. But docs are allowed to whip up stuff in their garage or direct someone else to by prescription.

Marketing of unapproved drugs or uncleared devices is prohibited. Off label use is common. I had one of my devices even being used for contraindicated procedures (a contraindication inherited from a predicated device via 510k clearance). The prohibition against marketing meant we couldn’t talk to customers about it, but they were still free to use it how they saw fit. Turns out the docs were right. After collecting enough data through non-marketing channels, we submitted a new 510k that demonstrated safety and efficacy of the off label use. Once cleared, we could remove the contraindication and begin marketing.

Meanwhile, insurance sometimes paid, sometimes didn’t. Depended on how it was coded.


Although MOST medical devices go through the 510k clearance process, some actually go through a more stringent premarket approval (PMA) process, which is an actual new approval and not a clearance based on a predicate device: https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/default.htm. Although the PMA process for medical devices is more rigorous than the 510k process, it largely applies to class III devices and it’s still not as thorough as the process for drug approvals (which isn’t really saying much).


Yeah, I try to avoid PMA’s like the plague. Even 510k’s with clinicals are better, if only marginally. I haven’t even worked on a Class I with exemption (ah, that would be nice!). Nor have I done HDE’s or CDE’s. I am working on a possible De Novo. Most of my stuff is 510k (when for US markets).

The EU on the other hand has just shot themselves in the foot. Or head. MDR’s are going to require clinicals for just about anything. But Europe doesn’t have the required clinical trial system set up. Luckily they will accept clinical trials done in the USA. But to do a clinical trial here, you either do a PMA or have a 510k in hand. This makes product development in the USA far easier than Europe, with product releases likely here long before Europe. At least, that’s the scuttlebutt that came out of the last regulatory conference I went to.


It’s good news. The world needs more babies, that’s for sure.


If the child is female, then mitochondrial changes are germline changes.

Note: I’m not arguing against this particular technique, or even germline therapy in general. I just have no idea what a smart framework for introducing and testing such techniques and therapies would even look like.


The world needs more [healthy] babies


What the world needs is more compasion for all the babies that are born, independently of their gender, race, state of health, or their parents’ socio-economic status or nationality.


True, but orthogonal to the discussion of fertility treatment.


I believe that the issue is here is not only fertility treatment but also genetic selection: “designer babies” that have or don’t have particular traits. You were the one to insert “healthy” in another commenter’s seemly sarcastic post, possibly referring to overpopulation. I insist that the need is not for more babies, or for healthier babies, but for a better life for all the babies that are already being born.


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