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Advertising Direct to Consumer Sales

Sheppard Mullin Richter & Hampton LLP

Ubrelvy Untitled Letter – A Double Fault for AbbVie? Or Makeup Misread for FDA?

On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television...more

Venable LLP

The Major Statement: FDA's Recent Q&A Guidance and Rulemaking on Direct-to-Consumer Prescription Drug Advertisements and the...

Venable LLP on

On December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Final Rule and Guidance on Direct-To-Consumer Prescription Drug Advertisements

In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and...more

Faegre Drinker Biddle & Reath LLP

FDA Issues Final Rule and FAQ Regarding Direct-to-Consumer Drug Advertising

In a stride toward transparency and heightened consumer awareness, the Food and Drug Administration (FDA) has issued a final rule, dated November 21, 2023, to amend its regulations regarding direct-to-consumer (DTC)...more

Foley Hoag LLP

FDA’s Major Statement: The Agency’s Recent Direct-to-Consumer CCN Final Rule, Q&A Guidance and Enforcement Trends

Foley Hoag LLP on

On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a...more

Foley & Lardner LLP

FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information

Foley & Lardner LLP on

In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs...more

Knobbe Martens

FDA Issues Long-Overdue Regulations on Direct-To-Consumer Advertisements for Prescription Medications

Knobbe Martens on

On November 21, 2023, the FDA published its final rule changing how prescriptions medicines are advertised to consumers. The FDA first issued its proposed rule in 2010, which subsequently went through three public comment...more

Morgan Lewis - As Prescribed

FDA Publishes Final Rule on Direct-to-Consumer Advertising Statements of Risk

FDA issued the final rule Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format (Final Rule) on...more

Foley & Lardner LLP

DTC Promotional Labeling and Advertisements: Quantitative Efficacy Wins Over FDA in Final Guidance on Presenting Risk Information

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In June 2023, the U.S. Food and Drug Administration (FDA) published final guidance (Guidance) on presenting risk and efficacy information for direct-to-consumer (DTC) promotional labeling and advertisements for prescription...more

Sheppard Mullin Richter & Hampton LLP

FDA Releases Final Guidance on Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and...

On June 27, 2023, the Food and Drug Administration (FDA) issued its final guidance for the presentation of “Quantitative Efficacy and Risk Information” in direct-to-consumer (DTC) promotional labeling and advertisements for...more

Foley Hoag LLP

OPDP Issues Final Guidance on Best Practices for Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer...

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On June 27, 2023, the Food and Drug Administration’s ("FDA") Office of Prescription Drug Promotion ("OPDP") published a final guidance (the "Final Guidance") on Presenting Quantitative Efficacy and Risk Information in...more

Arnall Golden Gregory LLP

I’m Looking Through You/You Won’t See Me: FDA Issues Guidance Document Concerning Presentation of Certain Information in DTC...

“I’m Looking Through You” and “You Won’t See Me,” both songs from The Beatles’ 1965 Rubber Soul album, came to mind when we read the Food and Drug Administration’s recently issued document, “Presenting Quantitative Efficacy...more

King & Spalding

FDA Finalizes Guidance on Presenting Quantitative Efficacy and Risk Information in DTC Promotion

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On June 28, 2023, the U.S. Food and Drug Administration (“FDA”) issued final guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (“Quantitative...more

Nelson Mullins Riley & Scarborough LLP

FDA Studies Foreshadow Potential Changes to Direct-to-Consumer Prescription Drug Advertising

The Food and Drug Administration (FDA) recently conducted two online studies concerning comprehension of direct-to-consumer (DTC) prescription oncology drug advertising.  The research suggests that consumers may have...more

Arnall Golden Gregory LLP

Out of Touch: FDA Takes Exception With Drug Company’s Promotion for Topical Drug Product

Who doesn’t remember Hall and Oates’ 1984 hit, “Out of Touch?” Perhaps, reviewers in the Food and Drug Administration’s Office of Prescription Drug Promotion were humming this song when it recently issued an Untitled Letter...more

Arnall Golden Gregory LLP

You Cannot Do It Any Way You Want It: FDA Issues an Untitled Letter for an Incomplete Journey Forward

Late last year, the Food and Drug Administration’s Office of Prescription Drug Promotion issued an Untitled Letter to a drug company for unlawful promotion of its biologic product....more

McDermott Will & Emery

[Webinar] Navigating Regulatory Landmines: Consumer Protection for Alcohol Beverage Companies - September 29th, 12:00 pm - 1:00 pm...

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Alcohol beverage companies must contend with an ever-evolving regulatory landscape, including unpacking the new environment under US President Joe Biden’s executive order on competition. How do you differentiate as a brand...more

McDermott Will & Emery

[Webinar] Navigating Regulatory Landmines: Consumer Protection for Alcohol Beverage Companies - August 12th, 12:00 pm - 1:00 pm...

As alcohol products compete in an increasingly competitive marketplace, how do you differentiate as a brand while being mindful of regulatory landmines? Join us for the second webinar in our Alcohol Quarterly Update Series on...more

Pillsbury Winthrop Shaw Pittman LLP

FCC Revises Equipment Authorization Rules

Relaxed rules will permit direct-to-consumer and importation rules for pre-authorization RF devices. Additional requirement adopted for consumer protection. ...more

BakerHostetler

FTC Says Razor Thin Market Share Not Enough for Merger Clearance and What It Means for Disruptive DTC Brands

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Last week, the Federal Trade Commission (FTC) filed a complaint in the U.S. District Court for the District of Columbia against Procter & Gamble to enjoin the consumer goods company from acquiring New York-based...more

Hogan Lovells

Business integrity for consumer companies

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Consumer companies around the world are incorporating sustainability, business integrity, and brand purpose into their business operations. This can include procuring ethically sourced products, ensuring fair pay, or...more

Mintz - Health Care Viewpoints

HHS Files Brief in D.C. Circuit Supporting Drug Pricing Transparency Rule

As promised, the Department of Health and Human Services (HHS) filed a brief in the United States Court of Appeals for the District of Columbia Circuit challenging the district court’s holding that the Secretary lacked the...more

K&L Gates LLP

K&L Gates Triage: Recent Developments Impacting Drug Pricing and the 340B Program: Part 1

K&L Gates LLP on

In Part One of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments that may affect drug pricing and pharmacy...more

Mintz - Health Care Viewpoints

HHS Drug Pricing Disclosure Rule: Chance at a Renewed Life Following District Court Appeal?

Looks like the Drug Pricing Disclosure Rule may not have seen its last day in court. On August 21, 2019, the U.S. Department of Health and Human Services (HHS) filed a notice of appeal against a federal judge’s decision to...more

Wilson Sonsini Goodrich & Rosati

Administration Again Attempts to Lower Drug Prices

In 2018, the administration published its Blueprint to Lower Drug Prices for U.S. citizens. The Blueprint included 12 proposed actions by the Department of Health and Human Services (HHS)....more

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