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Prescription Drugs False Advertising

King & Spalding

FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs

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On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more

Holland & Knight LLP

Holland & Knight Health Dose: November 7, 2023

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

King & Spalding

2022 Year in Review: FDA Drug and Device Advertising and Promotion Enforcement

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In 2022, the U.S. Food and Drug Administration (FDA or the Agency) issued a total of nine enforcement letters targeting advertising and promotion violations for prescription drugs and devices.  A summary of the noteworthy...more

Arnall Golden Gregory LLP

Freeze-Frame: FDA Issues an Untitled Letter for an Unlawful Instagram Post

Does anyone remember the 1980’s song, “Freeze-Frame” by The J. Geils Band? A new year, a new Untitled Letter issued by the Food and Drug Administration’s Office of Prescription Drug Promotion to a prescription drug company....more

ArentFox Schiff

New Headache for Trademark Litigants? Fourth Circuit’s Bayer Decision Rejects Application of State Statute of Limitations to...

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The Fourth Circuit recently held that the U.S. District Court for the Eastern District of Virginia erred in its analysis of a defendant’s laches defense against an unfair competition claim under Section 43(a) of the Lanham...more

Hogan Lovells

FDA cracks down on pharmaceutical firm for misbranding drug as COVID-19 treatment

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Last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted two more warning letters for 2020, bringing the tally to five warning and untitled letters for the year. These...more

Arnall Golden Gregory LLP

Don’t Tune Out OPDP’s Recent Warning Letter For a Violative Radio Advertisement

On August 31, 2020, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent a Warning Letter to the sponsor of a drug for a violative direct-to-consumer (DTC) radio advertisement.1   The radio...more

Smart & Biggar

Summary of various COVID-19 measures instituted by Health Canada

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Health Canada has instituted numerous measures to help address and combat COVID-19, from facilitating access to COVID-19 products to protecting the public from false or misleading advertisements claiming to prevent, treat or...more

World Law Group

[Webinar] International Regulatory Initiatives Directing to Improving the Delivery of Healthcare in the Fight Against COVID-19 -...

World Law Group on

WLG has collaborated with members to present a series of meetings and workshops to connect and educate members during the month of May. The Life Sciences Group will host a webinar "International Regulatory Initiatives to...more

King & Spalding

FDA Releases Draft Guidance on Promotion of Biological Reference and Biosimilar Products

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Part of a New Joint Initiative with FTC to Deter Anti-Competitive Practices, Including False or Misleading Comparisons - On February 3, 2020, the U.S. Food and Drug Administration (“FDA”) released draft guidance providing...more

Holland & Knight LLP

Healthcare Law Update: October 2019

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In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more

Pillsbury Winthrop Shaw Pittman LLP

Despite Amarin, ITC May Be Right Prescription For Pharma

Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could...more

Robinson+Cole Health Law Diagnosis

CMS Final Rule on Drug Pricing Transparency in Consumer Television Ads

On May 10, 2019, the Centers for Medicare and Medicaid published a Final Rule on drug pricing transparency in consumer advertisements. ...more

Goodwin

Novartis Sues Janssen Over Tremfya® False Advertising

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On March 1, 2019, Novartis sued Johnson & Johnson subsidiary Janssen for allegedly presenting false and misleading data about its plaque psoriasis drug Tremfya® (guselkumab). Novartis alleges that its Cosentyx® (secukinumab)...more

Foley Hoag LLP

Product Liability Update: January 2019

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MASSACHUSETTS - Massachusetts Supreme Judicial Court Applies “Transient Jurisdiction” Doctrine To Hold Nonresident Individuals’ Intentional, Knowing And Voluntary Presence In Massachusetts At Time Of Service Sufficient To...more

Hogan Lovells

Antitrust, Competition, and Economic Regulation Quarterly Newsletter - Summer 2018

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Read the latest news on antitrust, competition, and economic regulation in this summer edition of our quarterly ACER newsletter. ...more

Proskauer - Advertising Law

New Trial Ordered Where Jury’s Verdict Didn’t “Gel”

Last summer, we reported on a bizarre verdict in which an Illinois jury levied a $150 million punitive damages award against AbbVie, Inc., the drug company behind AndroGel, without awarding any compensatory damages. As...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | December 2017

Sen. Hatch Introduces New Bill Regulating Cosmetic Safety - Sen. Orrin Hatch (R-Utah) has introduced legislation aiming to modernize cosmetics regulation, proposing amendments to the Federal Food, Drug and Cosmetic Act...more

Proskauer - Advertising Law

Jury Tests the Limits in AndroGel False Ad Verdict

In late July, an Illinois jury came to a bizarre verdict in a case over an alleged link between heart attacks and AndroGel, a gel product used for treating low testosterone (or “low T”). The jury found that AbbVie, Inc., the...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | June 2017

LEGISLATION, REGULATIONS & STANDARDS - FTC Warns Companies and Social Media Influencers on Sponsorship Disclosure - The Federal Trade Commission (FTC) sent 90 letters to companies and social media influencers...more

Foley & Lardner LLP

Advancing New Claims Under the Lanham Act

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Implementing unique litigation tactics, on June 15, 2016, Foley & Larder LLP filed a complaint under Section 337 of the Tariff Act at the International Trade Commission (“ITC”) on behalf of Par Pharmaceutical and related...more

Patrick Malone & Associates P.C. | DC Injury...

Prosecutors win $67 million settlement with pharma firms accused of deceit

Federal prosecutors have wrung $67 million in a settlement with two pharmaceutical companies accused of deceiving doctors to prescribe a drug that the firms knew would be ineffective in treating lung cancer patients....more

Kelley Drye & Warren LLP

FDA Targets CBD Products, Claims Made in Social Media

Last February, FDA issued three warning letters to companies marketing cannabidiol (CBD) products as dietary supplements. FDA reviewed the companies’ websites and concluded that claims that CBD products could treat...more

Mintz

Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic...

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For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the...more

King & Spalding

First Circuit Finds Federal Preemption of State Tort Claims That Conflict With A Medication’s FDA-Approved Labeling & Warnings

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An opinion issued by the U.S. Court of Appeals for the First Circuit on February 20, 2015 held that the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempted claims that Lexapro’s U.S. Food and Drug Administration (FDA)...more

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