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Ellyn L. Sternfield

Ellyn L. Sternfield

Mintz Levin


Latest Posts › Pharmaceutical

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Grassley Questions Hospital 340B Program Profits

In a March 2013 article, I wrote about members of Congress calling for increased oversight of the 340B drug discount program and, in particular, hospital use of 340B drugs. This week, Senator Charles Grassley of Iowa...more

4/5/2013 - 340B Charles Grassley Healthcare Hospitals Medicare Pharmaceutical Prescription Drugs

FDA Will Not Appeal Second Circuit Decision in U.S. v. Caronia

After the Second Circuit’s split decision in U.S. v. Caronia, holding that truthful off-label marketing is protected under the First Amendment and thus cannot be prosecuted under the misbranding provisions of the Food Drug...more

1/30/2013 - Caronia FDA FDCA First Amendment Misbranding Off-Label Promotion Pharmaceutical Prescription Drugs

Off Label Marketing – First Amendment Challenge Ruling

The U.S. Court of Appeals for the 2nd Circuit upheld a First Amendment challenge to the federal prosecution of pharmaceutical salesperson Alfred Caronia for off-label marketing, http://www.ca2.uscourts.gov/decisions. Given...more

12/6/2012 - Commercial Speech FDA FDCA Free Speech Marketing Off-Label Promotion Off-Label Use Pharmaceutical

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