News & Analysis as of

Prescription Drugs Advertising

Think Your Prescription Drug Advertising is Beyond NAD’s Purview? NAD Disagrees.

by Kelley Drye & Warren LLP on

Those of us who spend our days at the intersection of law and advertising of health products generally accept that the prescription drug world is a universe unto itself, overseen by the FDA pursuant to the Prescription Drug...more

Advertising of unapproved therapeutic goods may soon be permitted

by Dentons on

Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 and Therapeutic Goods (Charges) Amendment Bill 2017 (collectively, the Bills) propose to bring significant changes to the Therapeutic Goods Act 1989 (the TG Act) and...more

Bad For Your Health: Lawsuit Advertising Implications And Solutions

by Shook, Hardy & Bacon L.L.P. on

Shook, Hardy & Bacon Partner Cary Silverman has authored a report for the U.S. Chamber Institute for Legal Reform examining the effects of advertising soliciting plaintiffs for lawsuits targeting prescription drugs and...more

New challenges and opportunities for pharmaceutical trademarks in Canada

by Smart & Biggar on

In Canada, trademarks for pharmaceutical preparations and related products have faced numerous challenges, some of which are unique to the industry. This article will canvas the current issues as well as the important changes...more

Coming soon from FDA? Streamlined safety information in prescription drug television ads

by DLA Piper on

Most people are by now familiar with prescription drug TV ads that provide lengthy (and often confusing) laundry-list descriptions of numerous potential safety risks (seemingly regardless of the severity or likelihood of the...more

Too Much or Too Little: FDA Requests Comments on New Strategy Regarding Risk Information in DTC Ads

by Hogan Lovells on

On August 21, 2017, FDA solicited comments in the Federal Register on a new potential approach regarding communicating risk information in direct-to-consumer (DTC) broadcast ads for prescription drugs and biologics that...more

Blog: FDA Solicits Comments Regarding Two New Studies Related to Drug Promotion

by Cooley LLP on

The U.S. Food and Drug Administration (FDA) published two Federal Register notices today announcing its intent to study different aspects of drug promotion. In Docket No. FDA-2017-N-1315, the FDA solicited comments regarding...more

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

Manatt on Health Reform: Weekly Highlights - March 2017 #3

House Republicans append a Manager's Amendment to the AHCA; HHS tells states they will have increased flexibility on Medicaid; and Florida previews its 1115 waiver amendment requests....more

The Art of the Drug Ad

Television spots touting prescription medications have flooded the airwaves for nearly 20 years. During that time, pharmaceutical companies marketing their products have become surprisingly savvy at delivering the message....more

Advertising Law - March 2016 #2

SPECIAL FOCUS: Lord & Taylor Settles With FTC for Not Disclosing Native Ads - Less than three months after the Federal Trade Commission issued its December 2015 Policy Statement and Business Guide on native advertising...more

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs

by Jackson Walker on

The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s...more

FDA Cites Drug Company for Kim Kardashian Endorsement

This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains...more

FDA Recalls Kim Kardashian’s Post

by Kelley Drye & Warren LLP on

Last month, Kim Kardashian praised Diclegis, a drug for morning sickness, on her social media accounts. Since Kim doesn’t follow us on social media, we don’t always keep tabs on her. But when her posts raise regulatory...more

Is Your SEM FDA Compliant? New Google SEM Policy Forces Pharmaceutical Industry to Adjust Paid Search Advertisements

by Reed Smith on

Upcoming changes to Google AdWords’ ad formats will have a significant impact on pharmaceutical companies that engage in paid search advertising. In a letter to its major media agencies last month, Google announced that it...more

The Revolution that Wasn’t: New Jersey’s Direct-To-Consumer Exception to the Learned Intermediary Doctrine

by Reed Smith on

The learned intermediary doctrine – in which a manufacturer’s duty to warn runs to the physician, not to the patient – is one of the most potent weapons in the arsenal for a pharmaceutical or medical device manufacturer faced...more

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

by Mintz Levin on

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

Advertising Law - March 2015

NAD: A Product Can’t be The “#1 Prescribed Brand” Without Other Prescribed Brands - A “#1 brand prescribed” claim implies that professionals have a choice in prescribing brands, the National Advertising Division...more

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

by King & Spalding on

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

FDA Revises Approach to Presentation of Risk Information in Brief Summary

by King & Spalding on

On February 6, 2015, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance titled Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more

Viagra Ad Campaign Targets Women Amid Melanoma Risk

Viagra is so popular that it is a frequent target of counterfeiters. Here, a U.S. Customs and Border Patrol agent displays seized goods. Viagra (sildenafil) has featured prominently in the news over the past few months...more

FDA One Step Closer to New Direct-To-Consumer Television Ad Requirements

by Reed Smith on

Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television advertisements. In a notice published in the Federal Register on January 13,...more

Beginning to Close the POM Circle? – POM Wonderful and Drug Advertising: JHP Pharmaceuticals

Earlier this year, in POM Wonderful LLC v. Coca-Cola Co.,[1] the Supreme Court examined the interaction between the Lanham Act’s prohibition against false advertising and the FDCA’s prohibition against food, drug and...more

FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms

by McDermott Will & Emery on

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first...more

Making Use of Social Media: FDA Releases Two Draft Guidelines on the Use of Social Media Platforms by Drug and Device...

by Mintz Levin on

The Food and Drug Administration (FDA) has released two long-awaited draft guidance documents for the drug and device industries revolving around the use of social media platforms by drug and device manufacturers —...more

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