Ellyn L. Sternfield

Ellyn L. Sternfield

Mintz Levin

Contact  |  View Bio  |  RSS

Latest Posts › FDA


Off-Label Marketing and the False Claims Act

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided...more

8/21/2015 - Amarin Commercial Marketing False Claims Act (FCA) FDA FDCA Off-Label Promotion Pharmaceutical Industry Ripeness

Emerging State Biosimilar Laws – Reference Chart and Five Issues to Watch

As we’ve previously discussed, states have begun to actively regulate the substitution of interchangeable biosimilars before any FDA-approved biosimilar has even hit the market. State biosimilar legislation passed to date...more

7/29/2015 - Biosimilars FDA Notification Requirements Orange Book Pharmacies Pharmacist

States Move to Impose Limits on Biosimilar Drug Substitution

In early April, Colorado joined multiple other states in passing a biosimilar substitution law that addresses the circumstances under which an FDA-approved interchangeable biosimilar product may be substituted for the...more

4/28/2015 - Biologics Biosimilars FDA Medicaid Medicare Pharmaceutical Industry Prescription Drugs

The Supreme Court Continues to Punt on False Claims Cases

The first day of the Supreme Court term saw it decline, without comment, certiorari on two cases raising issues of liability and the sufficiency of pleading under the federal False Claims Act (FCA). ...more

10/8/2014 - False Claims Act (FCA) FDA Omnicare Qui Tam Reporting Requirements SCOTUS

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 - FDA HRSA Orphan Drugs Pharmaceutical Industry Prescription Drugs Section 340B

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 (FCA) 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 Industry 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 Industry

8 Results
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.