Tag: Off-Label

United States v. Caronia: Some Preliminary Thoughts on the Second Circuit’s Decision Invalidating the Ban on Off-Label Promotion

Filed in Health Law by on December 4, 2012 2 Comments
United States v. Caronia: Some Preliminary Thoughts on the Second Circuit’s Decision Invalidating the Ban on Off-Label Promotion

Earlier this week, the Second Circuit Court of Appeals at last issued its decision in United States v. Caronia and it is momentous (and predicted to be heading to the Supreme Court).  A two-judge majority of the Circuit Court held that Alfred Caronia, a pharmaceutical sales representative, “was convicted for his speech – for promoting […]

Continue Reading »

Kate Greenwood on American Law Journal TV Regarding Off-Label Promotion

Filed in Drugs & Devices by on March 18, 2012 0 Comments
Kate Greenwood on American Law Journal TV Regarding Off-Label Promotion

In Case you missed it: Research Fellow & Lecturer in Law, Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, Kate Greenwood, on American Law Journal TV regarding Pharmaceutical Off-Label Marketing and Free Speech. A regular blogger here at HRW, Kate Greenwood appeared along with attorneys Hope Freiwald of Dechert, LLP and Brian […]

Continue Reading »

Does the Ban on Off-Label Promotion Bar On-Label Promotion?: The Case of Call Plans

Filed in Uncategorized by on November 6, 2011 2 Comments
Does the Ban on Off-Label Promotion Bar On-Label Promotion?: The Case of Call Plans

As predicted, in the wake of the Supreme Court’s decision in Sorrell v. IMS Health pharmaceutical companies have raised First Amendment challenges to the ban on off-label promotion on a number of fronts.  Most recently, Par Pharmaceutical sued to invalidate the ban to the extent that it “criminalize[s] Par’s truthful and non-misleading speech to healthcare […]

Continue Reading »

Distribution Controls: A Potentially Powerful Weapon Against Inappropriate or Dangerous Off-Label Use

Filed in Drugs & Devices by on July 12, 2011 1 Comment
Distribution Controls: A Potentially Powerful Weapon Against Inappropriate or Dangerous Off-Label Use

When supplies of sodium thiopental dried up earlier this year, states turned to other drugs to carry out executions by lethal injection.  The anti-seizure drug pentobarbital, marketed as Nembutal, is one such drug.  An estimated two-thirds of the thirty-four states with the death penalty have switched or considered switching to Nembutal; states that have made […]

Continue Reading »

Limit Physicians’ Off Label Prescribing Practices?

Filed in Uncategorized by on August 12, 2010 2 Comments
Limit Physicians’ Off Label Prescribing Practices?

Off label prescribing has become fairly common practice for many medical professionals.  Once a drug has been approved by the Food and Drug Administration (FDA) for a specific purpose, physicians are given the freedom to prescribe the approved drug “off label” for other beneficial uses of the drug.  There is a great interest for physicians […]

Continue Reading »