By Roland Nadler, 2L, Stanford Law School, Student Fellow, CLB
As many of our readers will know, last week the Food and Drug Administration let the regulatory hammer fall on 23andMe, last of the major direct-to-consumer personal genomics firms (at least, the last one dealing in single-nucleotide polymorphism analysis). As Hank Greely detailed in this space previously, the company seems to have exhausted the agency’s patience by engaging in an advertising blitz while maintaining a baffling radio silence vis–à–vis its regulator for six months. The move has touched off some truly stimulating debate in the law and biosciences communities; our local NPR, for instance, hosted a lively Forum segment featuring some familiar voices.
There is certainly plenty to debate. On the more formal legal side of things, commentators have been trading arguments regarding whether FDA can properly exercise jurisdiction over these sorts of direct-to-consumer tests in the first place, an issue which boils down in large part to whether it is correct to say that the product is “intended” for diagnostic use. But looming perhaps larger is the policy debate: should we be regulating this sort of personal genomic service, and if so, how aggressively? As the above-linked radio segment makes clear, the ongoing sparring over this question pits “health exceptionalists” — who believe that a certain level of paternalism is quite justified when it comes to health and medicine, where expertise can be a matter of life and death — against more libertarian–leaning individualists, who counter that consumers are perfectly capable of using their genomic information sensibly, that the market will provide adequate resources and guidance to help them do so, and that, anyhow, no government has the right to stand between individuals and (companies offering them) information about their own bodies.
A few minutes ago, on the last day on which comments would be accepted, I submitted the comments below to the Department of Health and Human Services in connection with its Notice of Proposed Rulemaking to amend its regulations under the National Organ Transplant Act. That amendment would, in effect, reverse the Ninth Circuit’s decision that hematopoietic stem cells removed from a donor’s blood through apheresis were not “bone marrow” or any other organ covered by the Act, and its criminalization of any compensation for the organ or tissue donor. I oppose the regulatory change, as should not surprise anyone who read my earlier post after the Ninth Circuit decision, here (along with Professor Alex Capron’s different view, here, and my response to him).
On Friday, November 22, the FDA sent a nastygram to 23andMe, the only remaining substantial pillar of the “direct to consumer” (DTC) genomic testing industry. The letter, available here, is well worth reading in its entirety, but, in brief, it told 23andMe, in no uncertain terms, to stop marketing its “Saliva Collection Kit and Personal Genome Service” (“the PGS”) on the ground that it was an unapproved and uncleared “device” under the Federal Food, Drug, and Cosmetics Act. It noted that the PGS, because of its lack of approval or clearance, was both adulterated and misbranded under the Act; the distribution of adulterated or misbranded devices is a federal crime.
23andMe’s initial response, click here, through an unnamed press spokesperson on its blog, was, at least on its face, conciliatory.
We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.
What’s going on – and what does it mean in the long run?
On Friday, FDA announced a proposed rule* that, if finalized, will represent a significant change for generic drug companies. Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA) requires that, to be approved, generic drugs have the “same”** approved labeling as the brand-name drug (known as the reference listed drug, or RLD), and it has long been FDA’s position that this “same labeling” requirement applies throughout the life of the drug. But the proposed rule announced Friday would change that position by allowing generic drug companies to substantively update their drugs’ labeling, without waiting for the RLD’s labeling to be updated first, to reflect newly acquired information about the drug. This is big news not just because it would change generic drug companies’ obligations under FDA regulations, but also because of what this change may mean for generic drug companies’ tort liability. Read the rest of this entry »
Basically, the Court (7 justices concurring in the per curiam, two “not voting” – what’s with that?) held that when the Oklahoma statute required that all “abortion-inducing drugs” be used only according to FDA-approved protocols, the proper statutory construction meant that it included all three drugs that same statute had defined as “abortion-inducing drugs”: RU-486 (mifepristone), misoprostol, and methetrexate. The problem is that the FDA approved protocol for using mifepristone requires the use of misoprostol as a second drug. But the FDA approved protocol for using misoprostol does not include its use in causing abortions.
The Journal of Law and Biosciences is a peer-reviewed, faculty-edited journal published by Oxford University Press. It will publish three issues a year (in March, July, and November), on-line, on all areas of the intersection of law and the biosciences, from patent law and FDA regulation to cognitive enhancement and genetic selection, with many stops between. The Journal is owned by Duke University, Harvard Law School, and Stanford University. Its founding three co-editors-in-chief are Nita Farahany at Duke, I. Glenn Cohen at Harvard, and me. We’re looking for a few good papers of up to 10,000 words. The Journal will also have a student-written “developments” section. The Journal is now accepting submissions; here’s the link.
About a year ago, this blog started a series on “bioscience” fiction: series intro. That series has, thus far, comprised one post, on Robert Heinlein’s short story, Jerry Was a Man (here). There has been no second. Until now.
One night earlier this month I just couldn’t face the philosophy book I was trying to use as bedtime reading and wandered over to my science fiction bookcase for something lighter. My eye fell on Childhood’s End. My Ballantine Book’s paperback copy (which cost me 75 big cents at the time) is from the 15th printing, in 1970. I probably hadn’t read the book since then, but I’ve remembered it warmly – really interesting plot and one great line. Forty-some years later – and 60 years after it was first published – it stands up well, although not entirely as I remember it.
For those of you who missed our Brains on Trial event on October 2nd, video of the panel discussion is now available on YouTube. The panelists were Silvia Bunge, Hank Greely, Robert Sapolsky, and Anthony Wagner, and the discussion was moderated by Alan Alda. Check out their interesting discussion of various law and neuroscience issues!