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Pharmaceutical Industry › Off-Label Use › Healthcare

Foley & Lardner LLP

GLP-1 Receptor Agonists: Clinical Trial Considerations

Foley & Lardner LLP on

The U.S. Food & Drug Administration (FDA) has approved certain GLP-1 drugs for commercialization and use, including liraglutide (Victoza®), semaglutide (Ozempic®, Wegovy®), and tirzepatide (Mounjaro®, Zepbound®). Although...more

Napoli Shkolnik

Product Liability: How it Works For and Against Victims of Defective Medical Devices

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Crafting the perfect medical device is never an exact science—but a patient should never suffer because of defects in a product that was intended to improve their quality of life. Determining whether a device manufacturer or...more

Jones Day

FDA Issues Revised Off-Label Communications Guidance

Jones Day on

The U.S. Food and Drug Administration ("FDA") has issued a revised draft guidance that seeks to address questions and provide recommendations regarding the sharing of scientific information with health care providers ("HCPs")...more

McDermott Will & Schulte

Detailed Summary of Federal Requirements for Production of Hand Sanitizing Products

McDermott Will & Schulte on

To meet the growing need for hand sanitizing products, various federal agencies including the Alcohol Tobacco Tax and Trade Bureau (TTB), Federal Drug Administration (FDA), Health and Human Services (HHS) and Congress have...more

Troutman Pepper Locke

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

Troutman Pepper Locke on

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

Hogan Lovells

FDA Clarifies “Intended Use” Regulations: Knowledge Alone ≠ Intent, But Knowledge Certainly Can Be One Element in...

Hogan Lovells on

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (“FDA” or “The Agency”) amended the intended use regulations for...more

Holland & Knight LLP

Healthcare Law Update: December 2016

Holland & Knight LLP on

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

Stinson LLP

Off-Label Promotion —To Speak or Not To Speak?

Stinson LLP on

Earlier this month, the U.S. Food and Drug Administration (FDA) announced a two day public hearing to take place November 9 and 10 aimed at obtaining input from industry to help shape FDA's policy regarding communications...more

McGuireWoods LLP

AdvaMed 2015 Highlights – Part One of Two

McGuireWoods LLP on

On October 5-7, 2015, the Advanced Medical Technology Association (“AdvaMed”) held its 40th Annual Meeting for the first time on the West Coast—San Diego, California. This year also signaled a change of AdvaMed’s membership...more

BakerHostetler

First Amendment Right to Off-Label Promotion – Has Pandora’s Box Been Opened for FDA?

BakerHostetler on

A handful of recent court decisions, including one issued just last month, seems to have potentially cracked open the door for pharmaceutical manufacturers to have more leeway to promote off-label uses of their products....more

Searcy Denney Scarola Barnhart & Shipley

Is Off-Label Drug Promotion Protected Free Speech?

Searcy Denney Scarola Barnhart & Shipley on

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

Patterson Belknap Webb & Tyler LLP

FDA Promises Guidance on Lawful Off-Label Promotion

Patterson Belknap Webb & Tyler LLP on

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

Bradley Arant Boult Cummings LLP

False Claim Act: 2013 Year in Review

Bradley Arant Boult Cummings LLP on

Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more

Mintz - Health Care Viewpoints

’Orphan drug’ rule raises off-label worries for drugmakers

Mintz - Health Care Viewpoints on

The U.S. Department of Health and Human Services last week clarified when hospitals are allowed to buy socalled orphan drugs at sharply discounted prices, but it left open questions for drug manufacturers about the risk of...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Second Circuit Vacates Conviction Based on Off-Label Promotion, Deals Blow to Government Theory in Drug Marketing Cases"

Skadden, Arps, Slate, Meagher & Flom LLP on

In a much-anticipated opinion, the U.S. Court of Appeals for the Second Circuit vacated and remanded the conviction of Alfred Caronia, a former pharmaceutical sales representative convicted of conspiring to introduce a...more

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