News & Analysis as of

Direct to Consumer Sales

Carlton Fields

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

Carlton Fields on

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...

Venable LLP on

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...

Ballard Spahr LLP on

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

Troutman Pepper Locke on

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

Lathrop GPM on

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

Foster Garvey PC

New Direct-to-Consumer Law Permits Shipments of Distilled Spirits, Cider and Mead to New Yorkers

Foster Garvey PC on

A new law in New York expands retail sales channels for many craft alcoholic beverage producers across the country. S.2852A/A.3132A, recently signed into law by Governor Kathy Hochul, introduces significant changes to the...more

Ballard Spahr LLP

Is your direct-to-consumer company using “dark patterns” on its website?

Ballard Spahr LLP on

Navigating the virtual marketplace has become an integral part of the consumer experience in the digital age. Lurking behind the convenience and accessibility of e-commerce websites, however, lies a subtle yet pervasive...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

ArentFox Schiff

Top Legal Challenges for the Automotive Industry in 2024

ArentFox Schiff on

With 2024 underway, we highlight some of the most pressing legal issues facing the automotive industry this year, including a surprise Federal Trade Commission (FTC) rule, changes to manufacturer direct-to-consumer sales, and...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

Troutman Pepper Locke

“Places of Business” Matter in the Virginia Alcoholic Beverage Control Act

Troutman Pepper Locke on

As we previously reported, most states authorize direct-to-consumer (DTC) shipments of wine if the shipper has obtained the correct license, but this area of law has continued to evolve through litigation. Recently, the...more

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

Hogan Lovells

Proposed FTC breach notice rule changes target direct-to-consumer health and wellness technologies

Hogan Lovells on

Responding to incidents impacting consumer health and wellness technologies, including apps, will be more complex under proposed breach notice rules by the U.S. Federal Trade Commission (“FTC”). Businesses have until August...more

Williams Mullen

North Carolina Legislature Considering New Version of ABC Omnibus Bill

Williams Mullen on

The North Carolina General Assembly recently passed Senate Bill 91, which included a technical correction to again allow breweries, wineries, and distilleries in North Carolina to obtain and hold private bar permits to sell...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...

Foley Hoag LLP on

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

Hogan Lovells

FDA concern over misleading DTC promotions increasing, new guidance suggests

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has finalized its 2018 draft guidance on “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements,” which offers...more

King & Spalding

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

King & Spalding on

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

126 Results
 / 
View per page
Page: of 6

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide