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