News & Analysis as of

Off-Label Promotion Pharmaceutical Industry

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

Dechert LLP

FDA Issues Revised Draft Guidance on “Off-Label” Communications to Health Care Providers – Expanded Scope, Yet Limitations Remain

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The FDA issued Revised Draft Guidance addressing communications by drug and device manufacturers about “off-label” uses of approved products. The Revised Draft Guidance supersedes FDA’s 2014 Draft Guidance on...more

Mintz - Health Care Viewpoints

Guidance from FDA Clarifies a Key Issue for Industry: Non-Promotional Presentations About Unapproved Uses of Medical Products Can...

U.S. health care attorneys, investors, and industry stakeholders are very familiar with the well-worn mantra that prescription drug and medical device companies are not allowed to “market” or “promote” their...more

Goodwin

How to Get Your SIUU Out: FDA Provides Long-Awaited Update for Industry on Communicating Off-Label Information

Goodwin on

On October 23, 2023, FDA announced the availability of a revised draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more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

Dechert LLP

FDA Issues Final Rule Clarifying Evidence of Off-Label Marketing

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Key Takeaways - Following more than five years of revisions and delays, the U.S. Food and Drug Administration (“FDA”) published its final “intended use” rule (the “Final Rule”) and amended its regulations describing the types...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

Arnall Golden Gregory LLP

Not a Very Happy Thanksgiving for One Pharmaceutical Company: OPDP Issues an Untitled Letter For Unlawful Promotion

Instead of sending a turkey and cranberry sauce, in the spirit of 2020 where nothing is normal, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) made a different delivery this year for...more

Troutman Pepper

Did Congress Intend to Criminalize Off-Label Promotion? One District Judge Suggests the Issue Is Ripe for Review

Troutman Pepper on

A judge in the District of Massachusetts recently questioned whether Congress intended to criminalize off-label promotion through misbranding and adulteration statutes. In an order denying a Rule 29 motion brought by two...more

McDermott Will & Emery

Fast Track for COVID-19 Drug and Vaccine Approval in the United States and Europe

McDermott Will & Emery on

The Coronavirus (COVID-19) pandemic poses an acute health risk to the population. One key to successfully combating COVID-19 lies in clinical research. Currently, almost all major research-based pharmaceutical companies, many...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

King & Spalding

2019 Year in Review: FDA Office of Prescription Drug Promotion

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In 2019, the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of ten enforcement letters targeting advertising and promotion violations for prescription drugs. Of the ten...more

Troutman Pepper

DTC Compounded Medications: A Treatment Option for a System in Need?

Troutman Pepper on

We have all been there: An advertisement on television or a pop-up on Facebook beckons us to try the latest “visit-free,” “delivered to your door” treatment for a medical condition. Originally published in Dermatology Times...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

Burr & Forman

The Causation Trend in Anti-Kickback False Claim Cases: Courts’ Rejection of Relators’ Taint Theory Should “Cause” Them Concern at...

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The False Claims Act (“FCA”) permits a person, known as a “qui tam relator” (or more commonly, a “whistleblower”), to bring a lawsuit on behalf of the federal government when that person has information that a healthcare...more

Arnall Golden Gregory LLP

Boxed Warning Drugs Beware!!

The Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) recently sent three enforcement letters (two Warning Letters and one Untitled Letter) to three prescription drug manufacturers. Both...more

Cozen O'Connor

The State AG Report Weekly Update November 2018 # 1

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Antitrust- FTC Reaches Settlement with Petroleum Company Over Allegedly Anticompetitive Impact of Proposed Acquisition of Retail Fuel Stations- The Federal Trade Commission (“FTC”), following an investigation by New...more

Womble Bond Dickinson

FDA Seeks to Provide Greater Insight on Off-Label Promotions of Pharmaceuticals

Womble Bond Dickinson on

The US Food & Drug Administration (FDA) serves as the gatekeeper between pharmaceutical companies and the public they serve, including governing how medications are promoted and advertised. Pharmaceutical companies want to go...more

Cozen O'Connor

The State AG Report Weekly Update August 2018 #2

Cozen O'Connor on

2018 AG Elections- Kansas Republican and Democratic Parties Nominate Attorney General Candidates Following Uncontested Primaries- Kansas held statewide primary elections on August 7, 2018....more

Cooley LLP

Blog: Two Enacted State Laws Permit Truthful Off-Label Promotion

Cooley LLP on

Earlier this month, Tennessee House Bill 2220 (substituted for Senate Bill 2361) (Tennessee Law) was enacted, which provides, “A pharmaceutical manufacturer or its representatives may engage in the truthful promotion of...more

Saul Ewing LLP

Ninth Circuit, in Solis, Reaffirms Two-Prong Approach to “Original Source” Exception Under Former FCA

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The Ninth Circuit recently reversed in part the district court’s dismissal of relator Frank Solis’ claims against his former employers for alleged False Claims Act (“FCA”) violations. According to Solis, the drug companies...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

Arnall Golden Gregory LLP

Don’t You Forget About Me: FDA Kicks off 2018 with Letters on Promotional Activities

FDA’s Office of Prescription Drug Promotion (OPDP) issued only five letters in 2017 (compared to eleven in 2016 and nine in 2015). This relatively slow year left some prescription drug manufacturers wondering if, to quote the...more

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