News & Analysis as of

False Advertising Food and Drug Administration (FDA) Pharmaceutical Industry

Axinn, Veltrop & Harkrider LLP

Rethinking Interchangeability, Top Cases, and Battling Misinformation at FDLI’s Annual Conference

1 Last week, the Food and Drug Law Institute held its Annual Conference while also celebrating its 75th anniversary. There, members of FDA and industry players gathered to discuss the latest legal, policy, and regulatory...more

Polsinelli

FDA Preemption of State Law for False Labeling Survives Appeal to Supreme Court

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Manufacturers of dietary supplements, food, beverages, and even medical devices can breathe a little easier following the Supreme Court’s denial of certiorari this week in a case seeking to overturn a First Circuit decision...more

BakerHostetler

AD-ttorneys@law - May 2022

BakerHostetler on

NAD Won’t Rename Supplement Maker - Innovix Pharma loses on product claims but gets to keep its calling card. Nerding Out - Aside from the intricacies of advertising, advertising law, and the disputes engendered...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

Womble Bond Dickinson

Can hashtags get you in trouble?

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They can if you operate in a regulated industry, such as pharma, med devices, cannabis, dietary supplements, etc. FDA has specific labeling requirements for products and they look at hashtags related to products the same...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

Butler Snow LLP

Development of the Food & Drug Administration

Butler Snow LLP on

The Food & Drug Administration is perhaps the most important, ubiquitous agency in the daily lives of modern American consumers. Consumers rely on the FDA to verify the safety and effectiveness of $2.6 trillion in food,...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

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

Mintz - Intellectual Property Viewpoints

Federal Circuit Affirms that the ITC Cannot Investigate an FDCA Violation without the FDA’s Say-So

In Amarin Pharma, Inc. v. Int’l Trade Comm’n (18-1247), the Federal Circuit affirmed the International Trade Commission’s (“ITC”) finding that Amarin’s false advertising claim under § 43(a) of the Lanham Act was precluded by...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin l November 2018

LEGISLATION, REGULATIONS & STANDARDS - Personal Care Products Legislation Introduced in Congress - Rep. Janice Schakowsky (D-Ill.) has introduced the Safe Cosmetics and Personal Care Products Act of 2018, which would...more

Hogan Lovells

A new normal in the pharmaceutical industry: How to fight back when your competitor can't stop fibbing

Hogan Lovells on

Center for Drug Evaluation and Research (CDER) Director Janet Woodcock, M.D., recently indicated that the Food and Drug Administration (FDA) is unlikely to take enforcement action against a pharmaceutical company committing...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | June 2018

LEGISLATION, REGULATIONS & STANDARDS - Hawaii Bans Two Sunscreen Ingredients - The Hawaii legislature has passed a law that will prohibit the sale or distribution of sunscreen containing oxybenzone and octinoxate after...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | April 2018

FDA Issues Guidance on Concentrated Caffeine - The U.S. Food and Drug Administration (FDA) has released guidance clarifying that "dietary supplements containing pure or highly concentrated caffeine in powder or liquid...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

Hogan Lovells

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

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The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...more

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

$70 million assessed against J&J for boy who grew breasts from Risperdal

A Tennessee teen-ager suffered such emotional distress after growing enlarged breasts as an undisclosed side-effect of an anti-psychotic medication that the drug’s maker should pay him $70 million in damages, a Philadelphia...more

Arnall Golden Gregory LLP

Off-Label Promotion and Product Liability: Are Industry’s Recent Court Wins in One Space a Win in the Other?

The pharmaceutical industry has recently felt empowered and emboldened by recent litigation that would seemingly allow companies to distribute, proactively, information about unapproved uses, i.e., off-label, so long as the...more

Skadden, Arps, Slate, Meagher & Flom LLP

"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

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

Faegre Drinker Biddle & Reath LLP

POM Wonderful™ News for Prescription Drug and Device Manufacturers?

Last week, the Supreme Court decided that POM Wonderful™, maker of pomegranate juice, could sue Coca-Cola Company, maker of a blended juice product that included pomegranate and blueberry juices, under the Lanham Act for...more

Dechert LLP

Second Circuit Holds Food, Drug and Cosmetic Act Does Not Prohibit Off-Label Promotion

Dechert LLP on

In a significant blow to the U.S. government’s enforcement efforts against the pharmaceutical industry, a panel of the Second Circuit overturned the conviction of a pharmaceutical sales representative for conspiracy to...more

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