News & Analysis as of August 3, 2025

Food and Drug Administration (FDA)

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The First Amendment to the United States Constitution prohibits the government from making laws respecting the establishment of religion, prohibiting the free exercise of religion, abridging the freedom of speech or the press, preventing citizens from peacefully assembling, or interfering with citizens' ability to petition the government for redress of their grievances. The First Amendment is one of the most sacred aspects of the American legal tradition and has spawned a vast body of jurisprudence and commentary. less -

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

Latham & Watkins LLP on 7/9/2025

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

The First Amendment and Direct-to-Consumer (DTC) Prescription Drug Ads

Brownstein Hyatt Farber Schreck on 7/8/2025

Department of Health and Human Services Secretary Robert F. Kennedy, Jr. has made no secret of his disdain for television advertisements for prescription drugs. As a presidential candidate, he promised to ban those ads by...more

Federal Court Blocks FDA’s Graphic Cigarette Warning Rule: The Limits of Regulatory Authority

BakerHostetler on 1/27/2025

On Monday, a federal judge from the Eastern District of Texas, Judge J. Campbell Barker, ruled that the U.S. Food and Drug Administration (FDA) exceeded its authority under the Tobacco Control Act by requiring cigarette...more

FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis

Ropes & Gray LLP on 1/14/2025

On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU)

King & Spalding on 1/14/2025

Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications - On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more

Industry Urges SCOTUS to Consider FDA Graphic Cigarette Warnings

Troutman Pepper Locke on 8/28/2024

In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

American Conference Institute (ACI) on 8/7/2023

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

American Conference Institute (ACI) on 7/5/2022

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

AD-ttorneys@law – October 2020 #4

BakerHostetler on 10/27/2020

Supremes Deny Energy Drink Company’s First Amendment Petition - 5-Hour Energy drink maker asks to pour unsubstantiated claims down the drain - Free Speech Spotting - Not too long ago, we covered a dustup between a state...more

What’s in a Patty: Does a Veggie Burger by Any Other Name Taste as Good?

Troutman Pepper Locke on 8/27/2020

Imitation meat has become ambitious. In contrast to past meat alternatives such as tofu or seitan, new meat substitutes are advertised as almost indistinguishable from the real thing. Advertising also focuses on current...more

Federal Courts Turn Away Challenges to FDA's e-Cig Regulations

Nilan Johnson Lewis PA on 12/18/2019

On Monday, December 16, 2019, the U.S. District Court for the Southern District of Mississippi granted the U.S. Food and Drug Administration’s motion to dismiss a lawsuit filed by trade organization United States Vaping...more

Administration Again Attempts to Lower Drug Prices

Wilson Sonsini Goodrich & Rosati on 8/26/2019

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

Taming Big Pharma profiteering is no snap, White House learns in dual defeats

Patrick Malone & Associates P.C. | DC Injury... on 7/15/2019

It takes more than a lot of huffing and puffing to blow down the ever-rising high costs of prescription drugs, the Trump administration has found. Two defeats happened last week: officials were forced to pull a plan to curb...more

Healthcare Law Update: July 2019

Holland & Knight LLP on 7/10/2019

CMS Regulation - District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements - The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...more

CMS proposes requiring drug prices in TV ads

Hogan Lovells on 10/24/2018

On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or...more

Trump Administration Proposes Requiring Disclosure of Drug Prices in TV Ads

Mintz - Health Care Viewpoints on 10/17/2018

The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”). Earlier this week, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed...more

Food & Beverage Litigation Update | September 2017 #3

Shook, Hardy & Bacon L.L.P. on 9/25/2017

FDA Announces Final FSMA Produce Safety Rule - The U.S. Food and Drug Administration (FDA) has announced that the produce safety rule of the Food Safety and Modernization Act of 2010 (FSMA) is now final, establishing...more

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

Hogan Lovells on 7/10/2017

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...more

FDA Provides a Healthy Extension to Comment on Healthy

Clark Hill PLC on 12/30/2016

In September 2016, the Food and Drug Administration (FDA) took a number of actions concerning the use of the term “Healthy” in the labeling of food products. The FDA published notice in the Federal Register on the use of the...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Skadden, Arps, Slate, Meagher & Flom LLP on 9/29/2015

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

Blog: Trend Watch: First Amendment Challenges To FDA Promotional Requirements Continue

Cooley LLP on 9/21/2015

In the wake of Amarin Pharma’s victory in securing a preliminary injunction against the Food and Drug Administration’s (FDA) prohibition of off-label communication of Vacepa , Pacira Pharmaceuticals has filed a First...more

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

Jackson Walker on 8/27/2015

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

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