By Scott Burris Phil Coffin and Sean Sullivan have published a cost-effectiveness study of interventions that equip heroin users and others to administer naloxone in the event of a witnessed opioid overdose. Naloxone is the standard antidote, and can easily be administered by lay people with a minimum amount of training. Family members and friends…
By Art Caplan [cross-posted from his NBCNews Vitals column] Two big events recently took place in the world of food: The Food and Drug Administration decreed that genetically engineered salmon wouldn’t harm the environment and McDonald’s announced that its McRib sandwich is back on the menu. The FDA’s announcement paves the way for the first approval of…
By Christopher Robertson I just came across this excellent story by Mina Kimes, which gives a detailed chronicle of how the lines between physician discretion, off-label promotion, and human subjects research can be blurred by an aggressive manufacturer, in a context where life or death is on the line (bone cement used in spine surgery).…
By The Petrie-Flom Center Last call! Abstracts for the Petrie-Flom Center’s annual conference – this year entitled “The Food and Drug Administration in the 21st Century” – are due today. This one and a half day event will take place Friday and Saturday, May 3-4, 2013, at Harvard Law School in Cambridge, Massachusetts. For further details, see the Call for…
By Suzanne M. Rivera How to Survive a Plague is a moving chronicle of the onset of the AIDS epidemic as seen through the lens of the activists who mobilized to identify and make available the effective treatments we have today. Beginning at the start of the epidemic, when little was known about the HIV…
By Patrick O’Leary As I’ve written about previously on this blog, the consequences for the FDA of budget sequestration under the Budget Control Act of 2011 could be fairly severe (as well as raise some interesting legal questions). In a recent Online First piece for the Journal of the American Medical Association (JAMA), Hamilton Moses…
By The Petrie-Flom Center Another reminder: abstracts for the Petrie-Flom Center’s annual conference – this year entitled “The Food and Drug Administration in the 21st Century” – are due one week from today, no later than December 14, 2012. This one and a half day event will take place Friday and Saturday, May 3-4, 2013, at Harvard Law School in…
By Dan Vorhaus and Phil Ross (cross-posted from Genomics Law Report) For years, and with increasing frequency, health care and information technology companies have touted the potential of mobile medical and health applications and technologies to improve the quality and delivery of health care through the use of technology. While the future of mobile health (frequently…
By Frank Pasquale Back in 2011, the AJLM had a symposium issue anticipating major issues in 1st Amendment limits on FDA restrictions on off-label marketing. It was a prescient move, as Prof. Robertson’s post shows. Just as it did in Sorrell, the Second Circuit is using free speech jurisprudence to significantly expand pharmaceutical companies’ freedom of action to promote…
By Christopher Robertson Invoking the First Amendment protection of speech, the Second Circuit today reversed a criminal conviction for a drug salesman’s promotion of a drug beyond its FDA-approved uses. The case in U.S. v. Caronia; the opinion is here, and here’s the Reuters story. In First Amendment cases like Western States Medical Center and Sorrell v. IMS,…
