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?
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 »
in a way that I think means the S Ct will dismiss the case as improvidently granted.
Here’s the Oklahoma order, just out today: order.
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!
Hey CLB Podcast Listeners: Our new October 2013 podcast is up! In this edition, we discuss the law enforcement purposes exception to the Genetic Information Nondiscrimination Act (GINA); the risk of liver injury associated with acetaminophen and FDA regulation of the drug, and; concussions and the future of football. Enjoy!
U.S. v. Harkonen: Should Scientists Worry About Being Prosecuted for How They Interpret Their Research Results?
U.S. v. Harkonen — a case in which Dr. Scott Harkonen, former CEO of InterMune, was convicted of wire fraud based on a press release that discussed clinical trial results for one of InterMune’s drugs – has caused concern that Dr. Harkonen’s conviction means scientists could be subject to prosecution for (mis)interpreting their research results (see here, here, and here). Dr. Harkonen and others who have voiced these concerns make compelling points—specifically, that scientific debate about the interpretation of research results is commonplace, this debate is critical for medical research, and it must not be chilled. But are they right to argue that, if the Supreme Court declines to grant Dr. Harkonen’s petition for cert or otherwise allows his conviction to stand, Dr. Harkonen’s conviction puts such scientific debate at risk? I think the answer is, probably, “no.” Read the rest of this entry »