UPDATE: Second Circuit Rejects Government’s Off-Label Enforcement Approach
Posted on January 24th, by Michael Shapiro-Barr
UPDATE TO EARLIER POST:
On Wednesday, January 23, Food and Drug Administration officials said the government will not appeal the decision in the United States v. Caronia, No. 09-5006-cr (2d Cir. Dec. 3, 2012). The FDA decided against asking the court to rehear the case, and will not appeal to the Supreme Court. The FDA stated that it “does not believe that the Caronia decision will significantly affect the agency’s enforcement of the drug misbranding provisions of the Food, Drug & Cosmetic Act.”
Read Jesse Witten’s recent post on this case here.
Michael Shapiro-Barr
Health Group Analyst at Drinker Biddle & Reath LLP
Michael Shapiro-Barr is an Analyst in our Health Care Practice Group. His authored contributions to the blog are derived from his own experiences and perspectives on the life sciences industry. He is not a licensed attorney and his writings should not be viewed as legal advice.
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Latest posts by Michael Shapiro-Barr (see all)
- Sequestration: The Ripple Effect on the Life Sciences Industry - March 1, 2013
- UPDATE: Second Circuit Rejects Government’s Off-Label Enforcement Approach - January 24, 2013
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