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Food and Drug Administration (FDA) › Off-Label Promotion › Healthcare

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

BakerHostetler

How Far Is Too Far? Court Rules for Amarin in Off-Label Marketing Fight against FDA

BakerHostetler on

Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015, the U.S. District Court for the Southern District of New York ruled that...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June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion.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

Searcy Denney Scarola Barnhart & Shipley

Lawsuit Against Medtronic Alleges Racketeering Over Infuse Bone Graft

Searcy Denney Scarola Barnhart & Shipley on

When one big industry sues another we learn a lot about how business as usual is conducted. In this case Humana, a giant health insurer, has sued the medical device company Medtronic, maker of the Infuse bone graft. ...more

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