off-label marketing

Latest Headlines

Latest Headlines

Merck inks $5.9M settlement to wrap up AzaSite off-label investigation

Inspire Pharmaceuticals' AzaSite is approved to treat bacterial conjunctivitis, more commonly known as pink eye. But that's not all the company hawked it for when it was part of Merck & Co., the U.S. Justice Department says.

Pfizer extricates itself from investor suit with $400M settlement

Pfizer got a federal judge to toss an investor lawsuit last year tied its now-withdrawn pain drug Bextra. But it wasn't the only investor suit raising similar issues, namely that the board had not been forthright about issues with the drugs. Another was just days away from trial, that is until the drugmaker agreed to settle it for $400 million.

Free speech, PhRMA? Not in this off-label marketing case, feds say

The pharma industry's free speech stand in a whistleblower lawsuit against Millennium Pharmaceuticals? Not so fast, says the Department of Justice. The First Amendment doesn't protect speech that spawns illegal conduct, federal prosecutors say in their own brief in the case.

PhRMA jumps into Integrilin off-label case, free-speech arguments at the ready

Since a U.S. circuit court decided the First Amendment protected a pharma sales rep from off-label marketing charges, the free-speech arguments have multiplied in cases across the country, testing that Second Circuit decision in other regions.

PhRMA jumps into Integrilin off-label case, free-speech arguments at the ready

PhRMA has jumped into a California False Claims Act case, with a friend-of-the-court brief defending Millennium Pharmaceuticals, Schering-Plough and Merck's right to talk up unapproved uses of the clot-fighting drug Integrilin.

Feds cry foul at Allergan's free-speech defense in drug marketing case

While it was fighting a hostile takeover by Valeant Pharmaceuticals, Allergan found time to claim its free-speech rights in a dispute over eye-drug promotions. The U.S.-based drugmaker used a similar tactic back in 2009, in a lawsuit over its Botox marketing. 

Do reps push drugs off-label? Yes, a study suggests. Does it work? Also yes.

Studies have shown that cutting down on face time between pharmaceutical reps and healthcare providers can cut down on expensive brand prescribing. But now, new data suggest that scaling back rep visits can also lower off-label prescribing.

Glaxo settles multi-state off-label marketing probe with $105M fine

GlaxoSmithKline's latest penalty for improper marketing practices may seem little more than a slap on the hand--except that it's coming at the worst possible time for the embattled British drugmaker. GSK agreed to pay $105 million to settle charges in California, New York, Texas and more than 40 other states that it illegally promoted its asthma drug Advair and antidepressants Wellbutrin and Paxil.

Pfizer adds another $325M to Neurontin settlement tally. Total? $945M

Off-label marketing strikes again. Pfizer agreed to pay $325 million to wrap up claims that its Parke-Davis unit touted the epilepsy drug Neurontin for uses not approved by the FDA, costing healthcare payers millions in unnecessary spending.

FDA officials say they're 'serious' about pharma's free speech

FDA officials are having a rethink on free speech--and that could end with an about-face on off-label marketing.