News & Analysis as of

Life Sciences Off-Label Promotion

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

American Conference Institute (ACI)

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement in Life Sciences Series - April-May 2021

Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S. Department of Justice (DOJ) and a range...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement in Life Sciences Series

Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S....more

Skadden, Arps, Slate, Meagher & Flom LLP

DOJ’s Evolving Enforcement Approach to Off-Label Promotion

Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S....more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement Spotlight: US Prosecutors Continue To Target Medical Technology Companies

Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

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

Foley & Lardner LLP

DOJ Issues Guidelines for Enforcement Related to Off-Label Promotion

Foley & Lardner LLP on

On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

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

Skadden, Arps, Slate, Meagher & Flom LLP

"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate"

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

Morgan Lewis

European Life Sciences Review: Issue 3

Morgan Lewis on

Welcome to the third issue of our European Life Sciences Review that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

Skadden, Arps, Slate, Meagher & Flom LLP

"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

Latham & Watkins LLP

Lessons from Latham & Watkins’ Representation of Pacira Pharmaceuticals In Ground-Breaking Settlement with FDA

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FDA rescinds warning letter and admits to incorrect interpretation of drug’s labelling. What can the life sciences industry learn? On December 15, 2015, Pacira Pharmaceuticals, Inc. (Pacira) announced that the US Food &...more

Thomas Fox - Compliance Evangelist

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Insights Conversations: Life Sciences"

A healthy market for M&A activity, particularly cross-border deals, and a strict regulatory environment are the big factors influencing the health and activities of life sciences companies. Skadden partners John T....more

Dechert LLP

Dechert Survey of Securities Fraud Class Actions Brought Against U.S. Life Sciences Companies

Dechert LLP on

Publicly Traded Life Sciences Companies in the United States Remain an Increasingly Popular Target of Securities Fraud Class Action Lawsuits: The past year was particularly noteworthy with respect to the absolute and...more

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