Maya Florence

Maya Florence

Skadden, Arps, Slate, Meagher & Flom LLP

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"Financial Relationships Likely to Be a Focus in Life Sciences Enforcement and Litigation"

For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...more

1/22/2016 - Caronia DOJ Enforcement Actions FDCA First Amendment Healthcare Fraud Inducements Life Sciences Off-Label Promotion Off-Label Use Pharmaceutical Industry Physicians Yates Memorandum

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

9/29/2015 - Advertising Amarin Caronia Commercial Speech Corporate Counsel Criminal Prosecution DOJ Enforcement Actions False Advertising FDA FDCA First Amendment Health Care Providers Labeling Medical Devices Misleading Impressions Off-Label Promotion Pharmaceutical Industry Popular Product Labels Ripeness Warning Letters

"Supreme Court Decision in FCA Case Both a Win, Setback for Health Care Providers"

On May 26, 2015, the U.S. Supreme Court issued a rare unanimous decision in a False Claims Act (FCA) case that cuts both ways for the health care industry. In an opinion authored by Justice Samuel Alito, the Court held in...more

6/1/2015 - Criminal Prosecution False Claims Act (FCA) Federal Contractors First-to-File Health Care Providers KBR (formerly Kellogg Brown & Root) Qui Tam SCOTUS Statute of Limitations Wartime Suspension of Limitations Act

"FDA Guidance Limits Flexibility in Social Media Promotional Communications"

Three recently issued draft guidance documents (Draft Guidances) from the U.S. Food and Drug Administration (FDA or Agency) are designed to assist manufacturers in product communications via social media and other interactive...more

7/22/2014

OIG Releases Updated Provider Self-Disclosure Protocol

On April 17, 2013, the Office of the Inspector General (OIG) of the United States Department of Health and Human Services released an updated Provider Self-Disclosure Protocol (SDP). As self-described, OIG updated the SDP to...more

5/21/2013 - Disclosure Requirements Eligibility OIG Self-Disclosure Requirements Transparency

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

Executive Summary - On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more

5/15/2013 - Civil Monetary Penalty Criminal Sanctions False Claims Act (FCA) FDA FDCA Penalties Settlement

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