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Big Changes in the Works for Generic Drug Labeling

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 »

OK S Ct Answers US S Ct's Questions in Cline v. OK Coalition for Reproductive Justice

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.

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The Journal of Law and the Biosciences Is Launched!

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.

Hank Greely

"Electroceutical" Ads Are Here. What Will Regulators Say?

Post by Roland Nadler

Next time you impulsively pull up YouTube to check out the adorable cat video du jour, you might find your fix delayed by a most unusual advertisement:

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BioSci Fi: Childhood’s End, Arthur C. Clarke, 1953

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.

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Video: Brains on Trial: A Panel Discussion Moderated by Alan Alda

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!

CLB Podcast: October 2013

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 »

SCOTUS Bioscience Cert Watch!

OT 2012 in the Supreme Court featured a total of five (maybe, five-and-a-half) bioscience cases: Bowman v. Monsanto (seed patenting); Mutual Pharma v. Bartlett (generic drug tort liability); FTC v. Actavis (pay-to-delay drug settlements); Maryland v. King(DNA collection of arrestees); and AMP v. Myriad Genetics (gene patenting). You can hear CLB’s podcast wrap-up of those decisions here.

But as Autumn comes and the leaves turn and Fall–well, in places other than evergreen Stanford, California–the Supreme Court is busy working on a new list of cases to hear for OT 2013. (At least until Friday, when it runs out of money.) And so–even though it’s ridiculously early to start counting these things–we thought it would be a good feature for CLB to update you on any bioscience cases the Court is slated to hear this term. All (maybe) three of them:

On. Oct. 16, the Court will hear Kansas v. Cheever, a criminal case slated to address whether a defense that focused on the neurological effects of the defendant’s habitual methamphetamine use counted as a “mental disease or defect” that allowed the trial court to order a psychiatric evaluation, otherwise in contravention of the Fifth Amendment’s protection against self incrimination. In other words–does, as a legal matter, smokin’ dat ice make you insane in the membrane?

On Nov. 12, the Court will hear a criminal case, Burrage v. United States, on whether one can be convicted for “distributing heroin causing death,” under 21 U.S.C. § 841,  if the cause of death was listed as “mixed drug intoxication.” This may seem like a run-of-the-mill criminal procedure issue on just how “proximate,” i.e., reasonably foreseeable, proximate cause needs to be. But, as noted by the government, the coroner’s report in the underlying criminal trial focused on the particular pharmacologic breakdown of heroin in the victim’s bloodstream. See Gov’t Br. at 4. If the coroner was wrong–or if the coroner’s opinion was uncertain–that may favor the petitioner-defendant. Frankly, it’s unclear how much this will play into the Court’s decision, but it’s something to watch out for.

Date uncertain: Cline v. Oklahoma Coalition for Reproductive Justice, on whether a state statute can condition the use of an abortifacient on-label, even if typical medical practice is to use it off-label, is still winding its way through the Oklahoma Supreme Court. Hank’s post about that case can be found here–with a correction here.

That’s it so far! We’ll keep you posted. You know, if the Supreme Court can get paid and get back to work any time soon.

Jacob S. Sherkow

Supreme Court Bioscience Wrap-Up Podcast

Hey CLB Podcast listeners: we’ve yet another podcast up for August 2013. Here, Hank and I wrap-up the five bioscience cases from the past Supreme Court term: Bowman v. Monsanto (seed patenting); Mutual Pharma v. Bartlett (generic drug tort liability); FTC v. Actavis (pay-to-delay drug settlements); Maryland v. King (DNA collection of arrestees); and AMP v. Myriad Genetics.

Enjoy!

Jake Sherkow