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Healthcare › Prescription Drugs › Off-Label Use

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

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The U.S. Food and Drug Administration ("FDA") has issued a revised draft guidance that seeks to address questions and provide recommendations regarding the sharing of scientific information with health care providers ("HCPs")...more

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

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

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

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