By Ryan Abbott Government regulation of off-label promotion by pharmaceutical companies is now an important First Amendment issue. The Food and Drug Administration (FDA) has historically restricted truthful and non-misleading speech by pharmaceutical companies under the Food, Drug and Cosmetic Act (FDCA). The FDCA prohibits introducing “misbranded” products into interstate commerce. The FDA has interpreted…
By Ryan Abbott Actavis is back in the spotlight regarding its allegedly anticompetitive behavior. Last month, the U.S. District Court for the Southern District of New York issued an injunction against Actavis and its subsidiary, Forest Laboratories LLC based on the New York Attorney General’s “product hopping” suit. The suit concerns Actavis’ attempt to extend monopoly…
By Ryan Abbott Video: Here. On January 13, 2014 the Southwestern Law School Federalist Society student chapter hosted a debate about the FDA’s role in regulating off-label drug use featuring Professor Richard Epstein, the Laurence A. Tisch Professor of Law at NYU and the Kirsten Bedford Senior Fellow at the Hoover Institution, and Ryan Abbott,…
By Ryan Abbott Historically, death has been a very simple and intuitive thing to understand – it occurs when someone stops breathing and their heart stops. Visually, it is a dramatic change that anyone can comprehend. However, we now live in an age where machines can keep people breathing, and their hearts beating, when they…
By Ryan Abbott Last month the US Supreme Court rendered its decision on the reverse payments question. The Court held in Federal Trade Commission v. Actavis, Inc. that reverse payment settlements in patent infringement litigation may violate antitrust laws, and therefore, these settlements are not immune from antitrust attack. Actavis, a generic drug manufacturer, settled…
By Ryan Abbott Justice Scalia filed an opinion concurring in part and concurring in the judgment of the Myriad decision. “I join the judgment of the Court, and all of its opinion except Part I–A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to…
By Ryan Abbott While awaiting the torrent of academic commentary on this case that is no doubt forthcoming, for now I thought I’d highlight a few interesting aspects of today’s unanimous Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, 569 U. S. ____ (2013). Briefly, this case concerned whether genes can be patented….
By Ryan Abbott The Indian Federal Department of Pharmaceuticals has released a new Drugs (Prices Control) Order that expands the list of “essential” drugs subject to government price control. Currently, a 1995 order restricts prices on 74 bulk drugs and their formulations; the new order would control prices on a total of 348 medicines that…
By Ryan Abbott I read an article recently which stated that the federal government is making a 51 billion dollar profit this year from student loan borrowers. That’s more annual profit than any private American business makes. Profit margins are up thanks to record interest rates and aggressive collection policies. Having the government make money…
By Ryan Abbott A few days ago, a group of more than 100 experts in chronic myeloid leukemia (CML) published an article in the medical journal Blood to draw attention to the prices of anti-cancer drugs and the effects of these prices on individual patients. The authors note that three new drugs were approved by the…
