News & Analysis as of August 9, 2025

Anti-Kickback Statute › First Amendment

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

Investigations Newsletter: Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict

ArentFox Schiff on 7/28/2025

Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict - Following a record $1.6 billion jury verdict for off-label promotion of HIV drugs Prezista and Intelence, Johnson & Johnson (J&J) subsidiary...more

Administration Again Attempts to Lower Drug Prices

Wilson Sonsini Goodrich & Rosati on 8/26/2019

In 2018, the administration published its Blueprint to Lower Drug Prices for U.S. citizens. The Blueprint included 12 proposed actions by the Department of Health and Human Services (HHS)....more

Healthcare Law Update: July 2019

Holland & Knight LLP on 7/10/2019

CMS Regulation - District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements - The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...more

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 12/13/2018

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 3/30/2018

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 12/5/2017

Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more

AGG Food & Drug Newsletter - March 2016

Arnall Golden Gregory LLP on 3/18/2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

DOJ Acknowledges in Proposed Jury Instructions That Dissemination of Truthful and Non-Misleading Off-Label Use Information Is Not...

Wilson Sonsini Goodrich & Rosati on 1/28/2016

For years, the U.S. Food and Drug Administration (FDA) has taken the position that a medical device (or drug) manufacturer that promotes an FDA-approved device (or drug) for an unapproved use violates the Federal Food, Drug,...more

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Anti-Kickback Statute › First Amendment

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