FDA Issues Stern Warning Letter — To Darwin Life — On “Three Parent” Human Genetic Engineering Of Embryos…

It was certain to be “top of mind“, in Silver Spring, Maryland — given last week’s startling news on the possibility of human embryo DNA corrections/ manipulation front — of last week. But to be clear — that was entirely academic (in vitro) research. No implantation (en vivo) was ever going to be attempted.

Now the US FDA (quite rightly, in my view) has made sure that the (self-described) “envelope pushers” out there (i.e., not the ethical scientists in the Journal of Nature linked article) are warned: “Don’t get out ahead of your regulator.” And do not assume that just moving the actual implantation operation, down to a med-spa located in Mexico will solve your FDA problems. [I am putting aside my own ethical qualms here, and those of many careful biological scientists around the world (for the moment), to focus exclusively on the US legal ramifications of such manipulation — in this post.]

This practice is simply unlawful. And it has been, for quite a while. And it should remain so. [Didn’t this joker see. . . “Jurassic Park“? Dr. Ian Malcolm (played by Jeff Goldblum)remains right here — about “can” doesn’t mean “should“.] Here’s the PDF file — and a bit — of the FDA warning letter — just issued:

. . . .Please be advised that you are using MRT to form a genetically modified embryo, which is subject to FDA’s regulations with respect to human cells, tissues, or cellular or tissue based products (HCT/Ps) under 21 CFR Part 1271, issued under authority of section 361 of the Public Health Service Act (PHS Act [42 U.S.C. 264]). HCT/Ps that do not meet all of the criteria in 21 CFR 1271.10(a) and do not qualify for any exceptions in section 1271.15, are subject to additional regulation, including appropriate premarket review.

The genetically modified embryo that you formed using MRT does not meet all the criteria in 21 CFR 1271.10(a) and does not qualify for any exceptions. Therefore the HCT/P is not regulated solely under section 361 of the Public Health Service Act (PHS Act) [42 U.S.C. 264] and the regulations in 21 CFR Part 1271, but is also regulated as a drug as defined under section 201(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)], and a biological product as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i). Specifically, your processing constitutes more than minimal manipulation of cells or nonstructural tissues, as defined in 21 CFR 1271(f)(2).

To lawfully market a drug that is also a biologic, a valid biologics license must be in effect [42 U.S.C. 262(a)]. Such licenses are issued only after a demonstration of safety, purity, and potency. While in the development stage, such biological drugs may be distributed for clinical use in humans only if the sponsor has an IND application in effect as specified by FDA regulations (21 U.S.C. 355(i); 42 U.S.C. 262(a)(3); 21 CFR Part 312). The MRT-produced HCT/P is not the subject of an approved biologics license application (BLA) nor is there an IND in effect. . . .

We request that you notify this office, in writing, of the steps you have taken or will take to address the violation noted above and to prevent recurrence. . . .

Now you know. Onward, into that brave new world. . . grinning widely, just the same. Dinner in the Loop ahead tonight, with my youngest son, and his new female fellow tri-athlete friend — visiting for a few days. . . . grin-worthy, indeed. . . . keep it spinning in natural Good Karma, one and all!

नमस्ते

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