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“NeuroRacer” Creator Gazzaley Seeks FDA Blessing for Brain Training Game

Roland Nadler

Three of my favorite topics — cognitive enhancement, administrative law, and video games — have collided in the headlines this weekend, with several games and tech news outlets reporting on a University of California San Francisco professor’s newly announced bid for U.S. Food and Drug Administration recognition that his lab-developed video game, NeuroRacer, is a safe and effective device for the treatment of cognitive decline in the elderly.

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Vermont to Pass GMO Labeling Law

Malia McPherson

Although Ben & Jerry’s, “Vermont’s Finest” ice cream, already committed to GMO labeling by the end of 2014, their state’s law will now be close behind. On April 23, the Vermont House gave final approval to a bill that will require labeling on foods containing genetically modified ingredients. Gov. Peter Shumlin tweeted that he would sign the bill into law, making Vermont the first state in the U.S. to mandate such labeling. Once the bill takes effect July 1, 2016, all Vermont-retailed foods with more than 0.9% of their total weight in genetically modified ingredients must be labeled with language stating, “may be partially produced with genetic engineering.” Although Connecticut and Maine passed labeling laws in 2013, their statutes stipulate that at least four nearby states pass similar laws before the requirements go into effect. The full, amended statute that passed the Vermont House and Senate can be found here.

But as NPR reported, Vermont’s attorney general is “bracing for a battle” — the bill itself established a $1.5 million fund to help defend against anticipated lawsuits. At stake are free speech issues, federal preemption, and agro-business pushback. Although we will have to “wait-and-see” what legal battles ensue, it is interesting to speculate. Who will fire first: General Mills, Monsanto, the FDA??

Malia McPherson is a first year JD student at Stanford Law School and an officer of its BioLaw organization.

A Second Zohydro Update

Last week I posted about Judge Rya Zobel’s order enjoining the Massachusetts Zohydro ban. While writing that post, I was wondering how Massachusetts would respond to the injunction. Now we know the answer. The night before the injunction was to go into effect, Governor Deval Patrick announced that the state would not appeal Judge Zobel’s order, and, instead of an outright ban on the use of Zohydro, Massachusetts would impose certain restrictions on its use similar to what Vermont has done.

The restrictions that Massachusetts has imposed include requiring Zohydro prescribers to complete a risk assessment and pain management agreement with patients, and participate in Massachusetts’s Prescription Drug Monitoring Program, which collects dispensing information on controlled substances to detect misuse.  If Zogenix chooses to challenge these restrictions – and I’m guessing it won’t because it hasn’t yet sued Vermont over its similar restrictions – one legal question would be: Are these restrictions, like the outright ban, preempted by federal law?

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Zohydro Update

Since FDA approved Zohydro in October 2013, the drug has been the subject of quite a bit of controversy.  In short, the concern is that Zohydro will contribute to the serious prescription drug abuse problem in the U.S. because, as an extended-release drug, it contains a higher dose of hydrocodone than other hydrocodone drugs on the market, and it lacks abuse-deterrent properties (see, e.g., this New York Times blog post).  Perhaps the most interesting part of this controversy is that Massachusetts has attempted to ban the use of Zohydro in that state—which I think makes Massachusetts the first state to flat-out ban an FDA-approved drug.

As we discussed in our recently posted April podcast, Zogenix Inc., Zohydro’s sponsor, sued Massachusetts over this ban (here’s the complaint).  When we recorded the podcast, the federal judge – Judge Rya Zobel of the District of Massachusetts – had not yet ruled on Zogenix’s motion for a preliminary injunction, and I predicted that she would not enjoin Massachusetts from enforcing the ban on preemption grounds.  Well, I was wrong.  On April 15th, Judge Zobel enjoined Massachusetts from enforcing or implementing its Zohydro ban because she concluded that Massachusetts “obstructed the FDA’s Congressionally-given charge” when it “interposed its own conclusion about [Zohydro’s] safety and effectiveness” (here’s the order).

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April Podcast

Podcast Listeners: Our April podcast is up! Listen to us talk about Zohydro, Ebola, biosimilars, and the Ninth Circuit’s en banc decision in Haskell v. Harris.

New Podcast: Top 5 Law and Bioscience Events of 2013!

Podcast Listeners: Our long lost December Podcast is up! Listen to us discuss what we think were the top 5 law and bioscience events of 2013.

Final Batch of 2014 CLB Workshop Mini-Podcasts!

The last two of our mini-podcasts with the 2014 CLB Workshop speakers are posted! Listen to Victoria Stodden (Columbia) discuss data transparency, and Ryan Abbott (Southwestern) discuss off-label use of drugs and devices.

Can Genome Editing Cure AIDS?

Hinco Gierman

Yes. At least, in theory. But, theory might soon become practice according to this week’s issue of the prestigious New England Journal of Medicine [1]. It published the first clinical trial of genome editing, in which the DNA of 12 human volunteers was “edited” to make them “genetically resistant” to the HIV virus.

What do I mean by genome editing and is it safe? How is this different from other gene therapies? Why would this cure AIDS? Is it unethical to genetically modify humans? And of course most importantly, should we be worried about “genetically modified super-humans” taking over the planet?

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Breaking News – Ninth Circuit En Banc Opinion “Affirms” Haskell v. Harris

Just released, the Ninth Circuit en banc, has affirmed the ND Ca decision (by Judge Charles Breyer) upholding California’s statute requiring people arrested for [corrected - thanks, Paul!]  any felony to provide DNA samples for inclusion in the state (and ultimately federal) database.

Sort of.

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March Podcast

Podcast Listeners: CLB’s March Podcast is up! Listen to us discuss Myriad Genetics and preliminary injunctions (01:25-11:59), the (in)accuracy of whole genome sequencing (12:00-13:27), tooth whitening and federal antitrust law (13:28-23:16), the ethics of mitochondrial transfer (23:17-34:14), and the (in)accuracy of a new blood test for Alzheimer’s disease (34:15-36:44).