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Did the Supreme Court Explode Drug Regulation While No One Was Looking? Don’t Panic!

Roland Nadler

Back in 2012, CLB Fellow Matt Lamkin blogged about a case that still haunts our nightmares. In United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that FDA regulations prohibiting off-label marketing of drugs violate the First Amendment … or, at least, hinted at that conclusion. The majority didn’t quite come out and squarely declare drug advertising regulation unconstitutional, much to our relief.

The regulatory state as we know it dodged a bullet in Caronia; ever since, Matt and I have been hoping and praying that the Supreme Court would never take up the case. We scanned the dockets for anything Caronia and, mercifully, it never appeared.

… or did it? What if the Supreme Court snuck Caronia’s holding into a different case, right beneath our noses? What if its holding was even broader than Caronia, threatening not just drug regulation but practically all advertising regulation and professional oversight? What if that case was decided 9-0? What if a leading expert said of the decision that its logic “would roll consumer protection back to the 19th century” … ? Read the rest of this entry »

Neuroimaging as Evidence of Pain: It’s Time to Prepare

[I wrote this post as part of the series on pain, brain imaging, and the law sponsored by the Center for Law, Brain & Behavior at Massachusetts General Hospital, the Petrie-Flom Center, and Harvard University’s Mind/Brain/Behavior Initiative. Contributors participated in the conference Visible Solutions: Now Neuroimaging Helps Law Reenvision Pain. For inquiries, please contact the organizer Amanda C. Pustilnik (@apustilnik on Twitter).]

The recent meeting at Harvard on neuroimaging, pain, and the law demonstrated powerfully that the offering of neuroimaging as evidence of pain, in court and in administrative hearings, is growing closer. The science for identifying a likely pattern of neuroimaging results strongly associated with the subjective sensation of pain keeps improving. Two companies (and here) recently were founded to provide electro-encephalography (EEG) evidence of the existence of pain. And at least one neuroscientist has been providing expert testimony that a particular neuroimaging signal detected using functional magnetic resonance imaging (fMRI) is useful evidence of the existence of pain, as discussed recently in Nature.

If nothing more is done, neuroimaging evidence of pain will be offered, accepted, rejected, relied upon, and discounted in the normal, chaotic course of the law’s evolution. A “good” result, permitting appropriate use of some valid neuroimaging evidence and rejecting inappropriate use of other such evidence, might come about. Or it might not.

We can do better than this existing non-system. And the time to start planning a better approach is now. (Read on for more on how)

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The Latest on Biosimilars: The Federal Circuit Holds that the “Patent Dance” Is Optional

In a previous post, I discussed a district court decision holding that the process for resolving patent disputes under the Biologics Price Competition and Innovation Act (BPCIA) is optional. That post contains extensive background on the BPCIA and its purpose of providing an abbreviated pathway for “biosimilar” drugs to get to market and compete with their branded analogs, resulting in lower prices for consumers. The bottom line is that, under the BPCIA, makers of biosimilar products can rely on the clinical trial data developed for the branded (or “reference”) product in order to accelerate FDA approval. Nevertheless, the BPCIA provides 12 years of data exclusivity to the manufacturer of the reference product. And beyond that period, even if the biosimilar garners FDA approval, the brand owner can try to continue to keep it out of the market by asserting claims of patent infringement. The BPCIA provides for a procedure involving pre-suit information exchange between the brand and biosimilar makers—the so-called “patent dance”—that is intended to apprise the brand of the biosimilar’s manufacturing process and narrow down the number of patents to be be asserted. But the district court, and now the Federal Circuit on appeal, have held that the biosimilar can lawfully refuse to participate in the patent dance.

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BioSci Fi: Asimov on Cognitive Liberty (Sort of)

The CLB blog has an occasional series on BioSci Fi – science fiction involving, at least to some extent, on bioscience. Today’s entry is from a 1955 short story by Isaac Asimov, collected, with a dozen other stories, in a 1968 book called Asimov’s Mysteries. I am addicted to (or at least psychologically dependent on) reading before going to sleep. The other night, looking for something light, I pulled from a shelf my 1969 paperback copy of that book, complete with brittle yellow pages, and started reading it, probably for the first time since 1969.

The story in question, The Singing Bell, is the first in the collection and is one of four featuring Dr. Wendell Urth. Urth is Asimov’s equivalent to Mycroft Holmes, a brilliant, reclusive, scholar who is useful for solving the occasional puzzle. The story – one of murder – is not particularly interesting except for Asimov’s introduction and treatment of an apparent kind of mind-reading device, the never-explained “psychoprobe.” What intrigued me, and led me to write this post, was Asimov’s discussion of the legal limitations that had been put on the use of the device, which included a principle that “the right to mental privacy..is fundamental.”

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From Elsewhere at Stanford Law School – Regulating Sugary Drinks

Stanford Law School has been lucky to add two great new people to our health law group lately, Michelle Mello, whom we stole from Harvard, and David Studdert, whom we imported from the University of Melbourne. Both focus on public health and have collaborated often; Michelle also works in bioethics.

The two combined with Stanford student Jordan Flanders to publish today an article in PLOS Medicine: Searching for Public Health Law’s Sweet Spot: The Regulation of Sugar-Sweetened Beverages. I’m not sure I approve of the title’s pun – though I’ll admit it’s not saccharine – but the paper is an interesting examination of what seems to work, and not work, in regulating sweet drinks, in the real world and in the courts.  Worth a read while downing your (caffeinated) Coke Zero.  There’s also a discussion of the piece in the Medical Center’s blog (we share Michelle and David, happily, with Stanford Medical School), Scope.

New CLB Podcast!

Check out our latest podcast, in which Dmitry talks about the Myriad Genetics settlement, Stephanie discusses “subjective punishment,” and Hank analyzes President Obama’s new precision medicine initiative.




On King v. Burwell and the Survival of the Affordable Care Act

Today is my birthday – and the Supreme Court (or, at least, two-thirds of it) just gave me, most people who follow health policy, and millions of now still-insured Americans a present: King v. Burwell.

There is a lot to say about this decision, but I want to focus on three things: the strength of the conflicting substantive arguments, the possible internal Court dynamics that resulted in the majority and dissenting opinion, and a guess at some deeper meanings of the case for the future of health care in America.

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2014-2015 Workshop Series: Mini-Podcasts with Glenn Cohen and Pilar Ossorio

Mini-podcasts for the last two speakers in the 2014-2015 Law and the Biosciences Workshop series are up! Listen to Hank Greely discuss exceptions to laws limiting abortion rights with Glenn Cohen and data sharing with Pilar Ossorio. The workshop series will resume in September.

Mental Health Month: Is Addiction a “Brain Disease”?

May being mental health month, I thought it timely to discuss one of the most costly mental health issues we face today: addiction.

Addiction exacts a huge toll on our society. In purely monetary terms, the National Institute of Drug Abuse estimates that addiction to alcohol, tobacco, and illegal drugs costs the U.S. $559 billion a year. This price tag results from increased health care costs, decreased productivity, and crime, and does not even include the cost of prescription drug abuse, which is on the rise. And as anyone who has experienced addiction up-close can attest, the personal costs of addiction are enormous. Addiction destroys families and lives.

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Update on the Patent Dance Case – Zarxio® Enjoined Pending Appeal

In an earlier post, I discussed a recent district court decision holding that the “patent dance” provisions of the Biologics Price Competition and Innovation Act are not mandatory. Yesterday, there was a new development in this case. The Court of Appeals for the Federal Circuit entered an injunction pending appeal preventing Sandoz “from marketing, selling, offering for sale, or importing into the United States its FDA approved ZARXIO® biosimilar product.” The oral argument in Amgen v. Sandoz on appeal is scheduled to be held on June 3.

Crowdsourcing Medicine?

There’s been a lot of talk about crowdsourcing lately. Everything from criminal investigations, to the tax code, to ski resorts have been crowdsourced or considered for crowdsourcing. And now medicine has thrown its hat in this trendy ring. KQED’s “Future of You” recently reported on a company called CrowdMed that wants to be the “Wikipedia of medicine.” (Due to space constraints, this blog post will not engage the important question of whether Wikipedia itself, is, in fact, the Wikipedia of medicine.)

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Do Biosimilar Manufacturers Have To Dance? A District Court Answers “No”

In 2010, Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) as part of the Affordable Care Act. BPCIA is, in a broad sense, intended to be the analog of the Hatch-Waxman Act for biologic drugs. Hatch-Waxman provides a pathway for Food and Drug Administration (FDA) approval for small-molecule generic drugs. Vastly simplified, the Hatch-Waxman process comes down to this: if a follow-on (i.e., generic) manufacturer can make an identical copy of the branded drug molecule, it can obtain FDA approval to market the drug without the clinical trials that the drug’s originator had to go through to prove that the drug is safe and effective. This saves costs for the generic manufacturer and, once the generic goes on the market, lowers prices for consumers. Under Hatch-Waxman, a follow-on manufacturer’s act of filing a so-called Abbreviated New Drug Application is an act of patent infringement, and so the originator can try to keep generic drugs off the market using patent law. The Food, Drug, and Cosmetics Act also provides periods of market and data exclusivities even for originator drugs that are not covered by patents. But once those periods end and the generic manufacturer can prove chemical identity to the brand, the generic drug is good to go on the market as far as the FDA is concerned—and the only barrier left is the brand’s potential patent infringement claims.

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Call for Applications!

For those of you who may have an interest in the intersection of Law, Policy, and Neuroscience, we are now looking for our next SPINS (Stanford Program in Neuroscience and Society) fellow. See the call for applications here.

An Off Topic Side Note on Asilomar, the Place

Asilomar is one of my favorite places in the world. It is just on the west side of the northern end of the Monterey peninsula in Central California, between the towns of Pacific Grove and Monterey to the east and Pebble Beach to the south. Although it is used as a geographical designation for that part of the peninsula, the name comes from a conference center created by the Young Women’s Christian Association (the YWCA), which sits on and behind sand dunes, just across the road from the surf and tide pools of the Pacific.

The following history is taken largely from the history page at the Asilomar Conference Center’s web site: http://www.visitasilomar.com/history/asilomar-the-complete-story.aspx. From 1900 the YWCA held annual meetings of its Pacific Coast Field Committee and a Western Regional Conference at a hotel in Santa Cruz, California. That hotel burned down in 1912, leading the committee decided to build its own site.

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On Asilomars

The very long post I put up yesterday about the call for a moratorium on germline genome modification in humans made me think about Asilomar and its parallels. I know that STS (Science, Technology, and Society or Science and Technology Studies) scholars have long debated the value of the “first” Asilomar, the Asilomar Conference on Recombinant DNA held in February 1975, and its lessons for other efforts. I have not looked into any of that research for this post, but instead am putting up my very lightly researched thoughts. I conclude that, at this point, there have been at least two “Asilomars” with several other contenders for the label and two other topics possibly ripe for one.

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Of Science, CRISPR-Cas9, and Asilomar

On Thursday, March 19, 2015 Science published (on-line) a Policy Forum entitled  A Prudent Path Forward for Genomic Engineering and Germline Gene Modification.  The piece had 18 authors, including David Baltimore, Paul Berg, Alta Charo, George Church, George Daley, Jennifer Doudna, Ed Penhoet, Keith Yamamoto, and (as, with Alta, one of only two non-scientists and definitely as one of the lesser lights) me. The Policy Forum recommended that steps be taken to “strongly discourage…any attempts at germline genome modification for clinical application in humans, while societal, environmental, and ethical implications of such activity are discussed among scientific and governmental organizations.”

A bit more than forty years earlier, on Monday morning, February 27, 1975, David Baltimore opened the famous Asilomar conference on recombinant DNA. That conference had been called after a letter in Science from the leaders in the field called for a moratorium on recombinant DNA research until important safety issues could be worked out. The three and a half days of the Asilomar meeting produced safety guidelines which led the group to lift their (totally informal and non-binding) moratorium – and ultimately led the NIH Recombinant Activities Committee; to federal (and foreign) biosafety regulations; in some tellings the wildly successful application of recombinant DNA techniques to research and medicine; and, undoubtedly, the most famous story in modern scientific self-regulation. (An excellent, non-speculative, memoir of the Asilomar meeting by George Frederickson, head of the Institute of Medicine at the time of Asilomar and director of NIH a few months later, can be found here.)

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Stanford’s SCOPE Blogs on Hank Greely and Genome Engineering

Our own Hank Greely has co-authored an article, published yesterday in Science, discussing the opportunities and challenges presented by genome engineering technologies. Krista Conger, writing for SCOPE, the Stanford Medical School’s blog, discusses the article in a recent post.  Read Krista’s post here.

In The Spirit Of Spring Break

It’s almost spring break here at Stanford, and in that vein, I thought I’d talk about a topic that is likely to be on at least a few spring breakers’ minds: marijuana.* Last week, a bipartisan trio – Senators Booker, Gillibrand, and Paul – proposed the Compassionate Access, Research Expansion, and Respect States (CARERS) Act, which has been described as the “first ever” Senate bill to “legalize” medical marijuana.

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This is Your Brain on Politics

It is a tautology to say that our political views affect our attitudes toward various societal issues. If I knew in advance whether you were a conservative or a liberal, for example, I could probably predict with better-than-chance accuracy your views on climate change, teaching evolution in public schools, or genetically modified foods.

But did you know that our political leanings can also alter our perceptions of reality?

This may seem surprising, but it’s true. A growing body of research shows that our political beliefs can influence not only the way our brains interpret and remember scientific information, but even our subjective perceptions of our physical environments.

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2014-2015 Workshop Series: Mini-Podcasts with Nathan Cortez & Margaret Foster Riley

Mini-podcasts for the latest two speakers in the 2014-2015 Law and the Biosciences Worshop series are up! Listen to Hank Greely discuss mobile health with Nathan Cortez from SMU and bioengineered meat with Margaret Foster Riley from UVA.