News & Analysis as of

Direct to Consumer Sales

BakerHostetler

Navigating Legal and Regulatory Risks in Direct-to-Consumer Pharmacy Models

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As pharmaceutical manufacturers, digital health companies and telehealth platforms continue to reshape the delivery of medications, DTC pharmacy models have emerged as a critical component of patient engagement and...more

Clark Hill PLC

Can Distilleries Ship Spirits Direct-to-Consumer in California? California’s New Spirits Shipping Law Explained

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Yes, as of January 1, 2026, distilleries will be permitted to ship spirits direct-to-consumer in California under the state’s groundbreaking new alcohol shipping law, Assembly Bill 1246, signed by Governor Gavin Newsom on...more

Mintz - Health Care Viewpoints

A Pivotal Week for Pharmaceutical Policy: Trump Administration Advances Tariff and Drug Pricing Initiatives

The first week of October 2025 marked a significant shift in U.S. drug pricing policy as the Trump administration unveiled a series of sweeping actions to deliver on his promise to lower drug prices. From President Trump’s...more

Morgan Lewis - As Prescribed

Marketing Medical Devices: Navigating Increased FDA Scrutiny

With the US Food and Drug Administration’s (FDA) September 9, 2025 announcement that it will increase its enforcement of the Federal Food, Drug, and Cosmetics Act (FFDCA), its rules governing direct-to-consumer (DTC)...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Wave of Untitled Letters Signals Stricter Scrutiny for DTC Pharma Ads

On September 9, 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued numerous untitled letters as part of the agency’s wider attack on direct to consumer (“DTC”)...more

ArentFox Schiff

FDA Launches National Sweep of Deceptive Drug Advertisements

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Earlier this month, the US Department of Health and Human Services (HHS) and US Food and Drug Administration (FDA) announced a nationwide crackdown on direct-to-consumer (DTC) drug advertisements....more

Epstein Becker & Green

HHS, FDA Target Direct-to-Consumer Drug Advertising: A Paradigm Shift in Patient-Focused Communications

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On September 16, 2025, the U.S. Food and Drug Administration (FDA) released more than 60 warning letters sent to specific pharmaceutical manufacturers, alleging misbranding of a particular drug through direct-to-consumer...more

Latham & Watkins LLP

FDA Begins Crackdown on Direct-to-Consumer Pharmaceutical Advertising

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FDA’s two-part strategy for reining in DTC advertisements involves greater enforcement combined with rulemaking to require more risk information in broadcast advertisements....more

Kelley Drye & Warren LLP

FDA Announces ​“Crackdown on Deceptive Drug Advertising” with Important Implications for Traditional and Digital Media Advertisers

Last week, the White House issued a memorandum directing the Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr., to take ​“appropriate action to ensure transparency and accuracy in direct-to-consumer...more

Ankura

Most Favored Nation Drug Pricing Developments

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On July 31, 2025, the White House released a fact sheet discussing additional steps taken by the Trump administration surrounding efforts towards lowering drug prices for Americans. ...more

Arnall Golden Gregory LLP

Talkin’ Bout a Revolution in Drug Advertising: What FDA’s DTC Crackdown Means for Pharma

Channeling Tracy Chapman’s 1988 hit, the Food and Drug Administration and the Department of Health & Human Services (“HHS”) are “talkin’ bout a revolution” in drug promotion. While many have described the latest actions as...more

Loeb & Loeb LLP

FDA's Direct-to-Consumer Advertising "Crackdown": Impacts to Brands, Agencies and Influencers

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he Food and Drug Administration (FDA) issued a press release on Sept. 9 announcing a “crackdown” on direct-to-consumer (DTC) pharmaceutical advertising and promising “sweeping reforms" in line with President Trump's same-day...more

Orrick, Herrington & Sutcliffe LLP

FDA Launches Aggressive Crackdown on Direct-to-Consumer Drug Advertising It Considers Misleading

FDA’s recent announcement that it is undertaking sweeping reforms and a major enforcement initiative targeting allegedly misleading direct-to-consumer (DTC) prescription drug advertising will have significant implications for...more

Gardner Law

FDA Sends 100 Cease-and-Desist Letters: A Warning to Industry

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On September 9, 2025, the U.S. Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) dropped a regulatory bombshell: the FDA issued approximately 100 cease-and-desist letters and thousands of...more

Ropes & Gray LLP

The Administration Targets Direct-to-Consumer Prescription Drug Advertising

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On September 9, 2025, the U.S. Food and Drug Administration (“FDA”) issued a Press Release announcing a “crackdown on deceptive drug advertising.” Concurrently, the U.S. Department of Health and Human Services (“HHS”)...more

Hogan Lovells

FDA ramps up drug ad enforcement, targets social media

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The U.S. Food and Drug Administration (FDA) announced it is changing its approach to direct-to-consumer (DTC) drug advertisements after a directive from a White House Memo instructing FDA and HHS to “to ensure transparency...more

Holland & Knight LLP

FDA Enforcement Against Dental Lab Could Have Broader Implications

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The U.S. Food and Drug Administration (FDA) recently published a warning letter (Warning Letter) targeting a dental laboratory after a lengthy inspection found that the dental laboratory's operations, which offer...more

Davis Wright Tremaine LLP

Food Venture Financing News – Weekly Issue No. 248

Food Venture Financing Trends - Saudi Arabia-headquartered food tech startup Calo, specializing in direct-to-consumer meal subscription services, secured $39 million in a Series B extension, which will enable them to...more

Latham & Watkins LLP

Senators Introduce Legislation to Restrict Direct-to-Consumer Drug Advertising

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On June 12, 2025, Senators Bernie Sanders (I-Vt.) and Angus King (I-Maine) introduced the End Prescription Drug Ads Now Act, with Senators Chris Murphy (D-Conn.), Peter Welch (D-Vt.), Jeff Merkley (D-Ore.), and Dick Durbin...more

Carlton Fields

Executive Order Seeks to Eliminate Discrepancies in Drug Pricing Between United States and Other Countries

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President Trump’s highly publicized executive order 14297, titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” targets the discrepancy in drug pricing in the United States compared with...more

Venable LLP

Are Hyperlinked Disclosures "Clear and Conspicuous"? Yes, in some cases, according to the FTC's Final Negative Option Rule - A...

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The Federal Trade Commission's Final Negative Option Rule ("Click to Cancel Rule") contains stringent new requirements for negative option programs, making it even more difficult to run compliant negative option offers....more

Ballard Spahr LLP

Consumer Finance Monitor Podcast Episode: A Look at the FTC’s Click-to-Cancel Rule, with James Kohm, Associate Director of...

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Today’s podcast features James Kohm, the Associate Director for the Enforcement Division of the Federal Trade Commission’s Bureau of Consumer Protection. We discuss the FTC’s “Click-to-Cancel” Rule (consisting of significant...more

Troutman Pepper Locke

Trends in State and Federal Regulation of Consumer Genetic Testing

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Direct-to-consumer (“DTC”) genetic testing companies are faced with more scrutiny than ever over their privacy practices, security practices, and data use policies. In December 2023, 23andMe experienced a data breach...more

Lathrop GPM

New Click-To-Cancel FTC Rule Carries New Rules, Hefty Penalties for Violations

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Attention, any companies that sell direct to consumers: the FTC has announced a new final rule requiring businesses to make it easier for consumers to opt-out and cancel subscriptions. Businesses will have 180 days to comply...more

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

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