CLB’s latest mini-podcast is up! Listen to Jill Horwitz (UCLA) discuss workplace wellness programs with CLB’s Hank Greely.
Last Friday, FDA announced a public meeting to obtain input on reworking the system through which it regulates most* over-the-counter (OTC) drugs, known as the “OTC monograph system.” This is big, and important, news.
OTC drugs are widely and routinely used, and are big business (in 2012, we spent 29.3 billion dollars on OTC drugs in the U.S.). Yet most OTC drugs are not “approved” by FDA. Instead, FDA publishes regulations, known as monographs, that set out what are, essentially, lists of permissible ingredients and labeling claims for therapeutic categories of OTC drugs (e.g., laxatives, antacids). If a drug meets the standards published in the relevant monograph, a company may sell the drug without pre-market approval from FDA. Sounds reasonable enough. But the problem is, as anyone who has any experience with notice-and-comment rulemaking will know, publishing regulations has become a very slow endeavor. Thus, although the monograph process started in 1972, many of the monographs are not yet final, and, more troublesome, FDA has not been able to respond quickly to safety concerns as new information about OTC drugs is learned. (See, e.g., Jake’s blog post from last year about the monograph covering antibacterial soap, and my discussion of the risk of liver injury associated with acetaminophen, the active agreement in Tylenol, in our Oct. 2013 podcast).
So how did we get where we are today?
The first set of our mini-podcasts with the 2014 CLB Workshop speakers is up! Listen to David Kaye (Penn State) discuss the 4th Amendment and DNA databases, Michelle Oberman (Santa Clara) discuss debates over abortion laws, Rebecca Dresser (Wash U) discuss incorporating subject perspectives into research ethics, and Dan Burk (UC Irvine) discuss the Supreme Court’s recent Myriad Genetics decision.
Almost four weeks ago, I had a pretty serious pulmonary embolism – a blood clot partially blocking the artery that goes from the heart to the lungs. (I’m fine, now, thanks, with no long-term harm except a likely need for life-long blood thinners.) I walked 100 feet and suddenly found myself gasping as though I had tried to sprint 200 yards. Even a serious denialist/”guy” like me knew that something was seriously wrong, and after quick consultation by phone with my doctor-wife, I hied me to an emergency room. I’m a happy Kaiser Permanente member (and she’s a happy Kaiser Permanente doctor), but the nearest Kaiser ER was at least a 25-minute drive away, so she instructed me to go to the Stanford ER, about a mile away.
Scientific American recently published a short essay by Roy H. Hamilton and Jihad Zreik, asking whether we should use devices (like tDCS, part of a larger category of brain stimulation technologies that I and others have blogged about before) to make ourselves smarter. I enjoyed it, and in no small part because the analysis breaks down the potential moral issues with cognitive enhancement into four basic categories — safety, distributive justice, autonomy / coercion, and authenticity — that happen to match the “four cardinal concerns” identified in the major empirical study of public attitudes toward cognitive enhancement that I helped author. But in reading the essay, and in revisiting the first-order moral question about whether we ought to enhance, I also felt a twinge of skepticism about the undertaking.
CLB Podcast Listeners: Our November 2013 podcast is (finally) up! In this edition, we discuss the Oklahoma statute prohibiting the off-label use of “abortion-inducing drugs” (and the related litigation), insurance coverage for conceiving a “savior sibling,” and patents and non-invasive pre-natal genetic testing. Enjoy!
Malia McPherson, SLS class of 2016
Big things are happening in St. Louis, Missouri, home to controversial, agriculture giant Monsanto. This year, the last Monsanto-owned patent for their blockbuster Roundup Ready® trait in soybeans is set to expire. The last applicable third-party patent for the trait will also expire in early 2015. While the effects of this legal change are speculative at best, farmers are looking forward to cheaper “generic” GMO soybeans and a return to seed-saving (the traditional way to replant crops rather than re-buying seed each year as required in Monsanto contracts). Farmers that export these crops, however, have only until 2021 to switch to Genuity® Roundup Ready 2 Yield® seeds, when Monsanto will no longer support the regulatory packages required for international sale (explained here).
While the Supreme Court upheld the enforcement of these patents last year in Monsanto Co. v. Vernon Bowman, public backlash against their products and environmental impact may be pushing Monsanto into a new field (no pun intended). In December, the company announced the start to a long-term strategic partnership with Danish company Novozymes, creating “The BigAg Alliance” aimed at microbial discovery and innovation. The press release, along with this nice chart, suggests that the alliance will work towards research, development, and commercial capabilities to create sustainable biological solutions in agriculture. It is an interesting move for Monsanto and perhaps an optimistic use of the word “sustainable.” But this venture brings to mind many questions about the way in which these two companies aim to innovate and profit from microbes.
One of my favorite regular columns is The Ethicist over at the New York Times. I am not entirely sure whether my rate of agreement with the recommendations has increased or decreased since Chuck Klosterman took over the post, but then, part of what makes me eager to read the column is that it is routinely just as stimulating to read it and disagree. Now, maybe I am peculiar in that regard — after all, it gives me an opportunity to think, “if I were the Ethicist …” and I suppose I do kind of relish imagining having the job. But at any rate, when Klosterman in today’s column missed what I felt was an important and useful angle in his response to a question about the ethics of advertising, I was hardly disappointed — mostly I was just glad for the prompt to piece together my own thoughts.
For those interested in the FDA approval process (and who isn’t!), the Jan. 22/29 issue of JAMA contains a worthwhile set of articles. Downing et al’s article, “Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012,” in particular, has gained attention (from, for example, the Wall Street Journal and Forbes). The article describes a study of the clinical trial evidence supporting FDA drug approvals, and the authors conclude that the quality of that clinical trial evidence “varie[s] widely.” As someone who used to work at FDA, this result strikes me as utterly unsurprising (and I imagine many FDA lawyers and scholars had the same reaction).
Guest Poster, Prof. Ryan Calo, former director of the SLS Center for Internet and Society
When the popular fantasy writer Robert Jordan died in 2007, his estate handpicked Brendan Sanderson to help finish Jordan’s epic Wheel of Time series. I thought Sanderson did a lovely job on the final books and decided to read one of his previous novels, Mistborn: The Final Empire. It turns out that Sanderson’s tale of inequality, though in respects overdone, enjoys strange and unexpected parallels to ongoing research into the bioscience of class.
In the latest salvo in Myriad Genetic’s bloody patent disputes with its BRCA-testing competitors, Myriad has sued LabCorp after the company announced it was to begin offering its own BRCA-testing product, BRCAssure. This brings to six the total number of companies held at the point of Myriad’s bayonet: Ambry Genetics, Gene-by-Gene, Quest, GeneDx, Invitae, and now, LabCorp. With the threat of these lawsuits, a purely commodified BRCA-testing market is not coming online any time soon.
From a purely patent law perspective, Myriad has several pretty good claims. Out of the patents in play in its loss before the Supreme Court earlier this year, Myriad still retains a number of valid claims: claims directed to BRCA cDNA and primers and probes used for BRCA sequencing, generally. In addition, Myriad has since acquired a number of new patents that have yet to be touched by any federal court. In both of these cases, Myriad’s competitors will need to prove by “clear and convincing evidence” that those claims are invalid–a particularly high bar.
Nonetheless, I think Myriad’s “scorched earth” litigation policy is suicidal. Why? For two, interrelated reasons: (1) because of a rule the Supreme Court established over forty years ago in a case called Blonder-Tongue Labs., Inc. v. University of Illinois; and (2) because of the current composition of the lower appellate court, the Federal Circuit. I’ll briefly explain both and then talk about how they come together to augur poorly for Myriad. Read the rest of this entry »
And it’s not the California Court of Appeals for the First District, the lower court in People v. Buza.
In People v. Lowe, the California Court of Appeals for the Fourth District, Division One (the “Inland Empire”), had upheld against a Fourth Amendment claim a conviction based in part on DNA identification stemming from a sample taken from an arrestee. The California Supreme Court granted and then, after the U.S. Supreme Court’s decision in Maryland v. King, sent it back to the lower court for reconsideration in light of that case. (It did the same with People v. Buza, which had gotten more attention because there the lower court had held the DNA provisions violated the federal constitution.)
Beginning in January, CLB will host its annual Workshop Series. The Workshop brings leading law professors and other academics from throughout the U.S. to present papers of interest to Stanford students, faculty, and members of the community. In previous years, the the Workshop has covered a variety of topics at the intersection of law and the biosciences, including bio-patents, DNA privacy, reproductive rights, science policy, bioethics, health insurance, neuro-law, and others.
The 2013 CLB Workshop Series will be hosted here, at Stanford Law School, and begin on January 7, 2014. All talks run from 4:15 p.m. to 6:15 p.m.; rooms will be posted closer to the talks’ dates. The Workshop is open to all students, faculty, and members of the Stanford community.
2014 CLB Workshop Series Schedule
January 7, David Kaye (Penn State)
“Why So Contrived? The Fourth Amendment and DNA Databases After Maryland v. King”
January 14, Michelle Oberman (Santa Clara)
“What’s Law Got to Do With It? Travels Through the Abortion War”
January 21, Ryan Abbott (Southwestern)
“Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices”
January 28, Rebecca Susan Dresser (Wash. U.)
“Taking Subjects Seriously: A New Look at Research Ethics”
February 4, Victoria Stodden (Columbia)
“Do Software Patents Slow Scientific Discovery?”
February 11, Lawrence O. Gostin (Georgetown)
“Imagining Global Health with Justice”
February 18, Dan Burk (Irvine)
“The Curious Incident of the Supreme Court in Myriad Genetics”
February 25, Jill R. Horwitz (UCLA)
“Who Pays for Workplace Wellness?”
March 4, Francis X. Shen (Minnesota)
“Synapses and Social Policy: Legislative Use (and Misuse) of Brain Science”
I forgot to mention this in my long post on the Haskell re-argument, but I thought it presented an interesting example of the costs and benefits of some rhetorical styles.
In Maryland v. King, Justice Scalia wrote the dissent in his usual understated (not) way. Near the end of that dissent, he wrote “Make no mistake about it: As an entirely predictable consequence of today’s decision, your DNA can be taken and entered into a national DNA database if you are ever arrested, rightly or wrongly, and for whatever reason.”
During the re-argument of Haskell, Judge Milan Smith (not Judge Randy Smith, who was also on the panel) repeatedly cited this language from Justice Scalia to show that Maryland v. King did control this case. Justice Scalia, who had sat in on the conference, said that this was what the case meant; therefore, how could the Ninth Circuit judges try to limit it?
It was a nice instance of trying to use someone’s perhaps excessive arguments against him. Scalia’s “parade of horribles,” which he clearly intended as potential, was used to against him to say that the Court must have already accepted that position.
As a matter of pure logic, I don’t think that works. That the dissent foresees terrible results from a majority opinion does not mean that the majority has accepted those terrible results. But it is a nice little move – and possibly a reminder to people “parade of horribles” arguments to qualify them carefully.
Back in June, a few days after the Supreme Court decision in Maryland v. King, I put up a long post on the possible ways California’s law requiring DNA “donation” from people arrested but not yet convicted of crimes might be distinguished from the Maryland law upheld by the Supreme Court. I followed it with a few shorter ones, here, here, and sort of, here. Today the Ninth Circuit heard re-argument, en banc, of Haskell v. Harris, the federal court challenge to the California statute. (A parallel state court suit, People v. Buza, was drop kicked by the California Supreme Court back to the lower appellate court for it to reconsider in light of Maryland v. King. As far as I can tell, nothing further has happened yet in that case.)
Happily, the Ninth Circuit decided to live stream this oral argument, making it available freely over the web to anyone interested. I watched the live stream and tweeted during it. Now I want to use this blog post to get down my first reactions, staring with four qualifications.
At 2:00 pm on Monday, December 9, an en banc panel (11 judges) of the United States Court of Appeals for the Ninth Circuit will argue, again, the constitutionality of California’s law requiring arrestees to provide DNA immediately for CODIS profiling. The district court judge upheld the law and a 2-1 decision of the appellate panel affirmed. The court granted rehearing en banc and heard the case argued in early September 2012 – eight weeks before the Supreme Court granted cert in Maryland v. King.
The Ninth Circuit then put the case on holding pending the Supreme Court decision. When that decision came down, it ordered supplemental briefs about the meaning of Maryland v. King for this case. It then ordered this re-argument.
Back in June, I put up a long post on the possible ways the court could distinguish California’s law from the Maryland law upheld by the Supreme Court, and followed it with a few shorter ones, here, here, and sort of, here. On Monday we’ll all have a chance to see what the en banc panel thinks – at least as far as their questions can show that.
To watch, go here shortly before 2:00 pm on Monday, December 9; click on Haskell v. Harris; and hope it works. Should be fun!
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).
My comments follow.
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?