Off-label

Social media an outcomes listening post for pharma

March 27, 2012

FDA issues may deter drugmakers from engaging in social media, but that's no excuse to ignore what audiences are saying on these platforms, say pharma and device firms.
 

Allergan scrubs some doc-payment data, spares med-ed grants

February 03, 2012

Allergan removed records from its website that had detailed payments made to doctors from the middle of 2010 through first-half 2011.
 

GSK hopes $3-bil. off-label settlement will end legal woes

November 07, 2011

GlaxoSmithKline's deal to resolve multiple US investigations into its sales and marketing practices—one of the largest settlements by a pharma company—aims to patch up several long-running legal disputes.
 

Par Pharma suit could set up off-label court showdown

October 18, 2011

Par Pharmaceutical last week asked a federal court to tell the FDA to back off and allow the company to detail docs about using its Megace ES to treat AIDS-related wasting.
 

Florida harasses dead doc for off-label months after suicide

July 26, 2011

The Florida Department of Health is seeking to sanction a doctor who committed suicide in February, distraught over getting swept up in an off-label promotion sting.
 

Pharmas ask FDA for guidelines on off-label info

July 06, 2011

Seven large pharmas filed a citizen petition with FDA asking for guidance on communication about off-label uses for products.
 

Off-label marketing offenses cost Elan $203 million

March 01, 2011

Elan Pharmaceuticals pleaded guilty today to a misdemeanor violation for illegally promoting epilepsy drug Zonegran.
 

Former Glaxo lawyer accused of marketing cover-up

November 09, 2010

A federal grand jury has indicted a former GlaxoSmithKline attorney for allegedly failing to comply with an FDA request for documents in an off-label marketing probe.
 

CIAs pressure pharma to rethink sales rep compensation

October 05, 2010

Novartis's recent off-label settlement with the Department of Justice -- to the tune of $422 million -- also included the signing of a Corporate Integrity Agreement (CIA) requiring the Swiss-based manufacturer to review incentive-based compensation for reps, and to examine "the extent to which compensation is based on product performance," according to the CIA.
 

Forest Labs to pay $313 million in DOJ settlement

September 16, 2010

Forest Laboratories is the latest pharmaceutical company to settle unlawful marketing allegations with a multi-million dollar payout - over $313 million - to the Department of Justice (DOJ), just two weeks after Allergan agreed to pony up $600 million to settle illegal Botox marketing practices.
 

Allergan drops FDA lawsuit as part of off-label settlement

, Matthew Arnold September 02, 2010

Before Allergan could begin settlement negotiations with the Department of Justice (DOJ) -- which ended with an agreement to pay $600 million on Wednesday -- DOJ required the Botox manufacturer to first withdraw a First Amendment lawsuit against the FDA filed last October.
 

Sales reps at J&J unit to get 'ride-alongs' as part of CIA

May 04, 2010

As part of an $81 million off-label settlement with the Department of Justice (DOJ), Ortho-McNeil Janssen Pharmaceuticals Inc. (OMJPI) sales reps will be buddied up with internal compliance monitors tasked with observing and reporting the rep's behavior out in the field.
 

AstraZeneca settles Seroquel off-label suit for $520m, CIA

April 27, 2010

AstraZeneca agreed to pay $520 million and enter a five-year Corporate Integrity Agreement to settle a federal case against the company for off-label marketing of Seroquel, the Departments of Justice and Health and Human Services' Healthcare Enforcement Action Team announced.
 

Video Exclusive

Web Exclusives

Five industry experts advise specialty pharma company on digital strategy

April 20, 2012

Specialty pharma company POZEN assembled a crack team of experts to help shape its digital strategy. Not only did POZEN share with us the text from their contributions, but you can watch exclusive video clips of their valuable perspectives right here.
 

MM&M Awards 2011 HIghlights

The Best MM&M Awards Ever!

MAHF Ceremony 2012

Photos from the Medical Advertising Hall of Fame Awards ceremony
 
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