Ellyn L. Sternfield

Ellyn L. Sternfield

Mintz Levin

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HRSA “Interprets” Its Enjoined 340 Orphan Drug Rule into Effect

In January, I predicted that 2014 would be a game-changer for the 340B Drug Discount Program, in part because of HRSA’s announcement that, in June 2014, it would for the first time publish an omnibus rule governing 340B...more

6/19/2014 - 340B Drug Manufacturers FDA HRSA Orphan Drugs Pharmaceutical Prescription Drugs

Does District Court Dismissal of Declined Qui Tam Threaten Future DOJ False Claims Enforcement?

The U. S. Department of Justice (DOJ) has taken the unusual step of appealing a federal district court’s dismissal of a declined qui tam brought under the federal and multiple state false claims acts (FCA). Could the...more

8/9/2013 - DOJ Enforcement Actions False Claims Act FDA Healthcare Medicaid Medicare Qui Tam Reporting Requirements

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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