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Off-label

Business Briefs Merck, GSK, Novo, Walgreen, Epocrates, Doximity

May 09, 2013

HPV vaccine price cut; Merck files new allergy med with FDA; GSK pursues online transparency; Walgreens ready for greater nurse autonomy; Epocrates ranks high among docs with tablets.

Novartis: lawsuits, layoffs and, by the way, earnings

Deborah Weinstein April 24, 2013

It was an all-in-one news day for the drug maker which, by the way, saw sales rise 2% for the first quarter, compared to the same period last year.

Business briefs: Endo; Allergan

February 27, 2013

Endo gets a new president, Allergan settles a Botox case

Business briefs: Gilead, Shire, The Medicines Co., HHS

February 04, 2013

HHS wants input for its TXT4Tots childhood advice program, Gilead releases some Hep. C clinical trial data, and Shire settles with the DOJ over disputed marketing practices.

Researcher takes aim at clashing drug data

Deborah Weinstein January 31, 2013

An expert witness in a 2008 lawsuit highlights holes in clinical data, and finds that corporate and published trial data do not necessarily correspond.

Amgen pleads guilty, takes CIA in $762 million False Claims Act case

Matthew Arnold December 20, 2012

Amgen "marketed the spread" between the price practices pay for Aranesp and that patients pay as a means of driving sales—to the point of having speakers tell docs that they could make a million more each year by prescribing the Amgen anemia drug over its competitor, Procrit.

Court says off-label decision against Jazz rep ran afoul of free speech protections

Matthew Arnold December 03, 2012

A federal appeals court has overturned the conviction of a drug rep for detailing a drug off-label on First Amendment grounds, ordering the lower court to retry the case.

Company news: Elsevier, Abbott, Genzyme

August 22, 2012

Elsevier launches new drug class overviews, a whistleblower accuses Abbott and Genzyme clears the way for Lemtrada.

Petition asks FDA to set opioid marketing ground rules

Deborah Weinstein July 26, 2012

The proposed changes center around non-cancer related pain and seek to alter how drug companies can talk about these pain meds.

GSK in biggest-ever $3b marketing fraud settlement

Matthew Arnold July 02, 2012

GlaxoSmithKline will pay $3 billion to settle state and federal charges that it promoted antidepressants Paxil and Wellbutrin for unindicated uses and withheld safety data on diabetes drug Avandia.

Social media an outcomes listening post for pharma

Marc Iskowitz 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

Marc Iskowitz 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

Marc Iskowitz 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

Matthew Arnold 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

Marc Iskowitz 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

Matthew Arnold 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

Marc Iskowitz 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

Marc Iskowitz 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

Ben Comer 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

Ben Comer 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

Ben Comer, 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

Ben Comer 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

Matthew Arnold 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.

Web Exclusive

What NOT to say to an MS Patient

Dorothy Wetzel June 07, 2013

It is often hard to find the right words when talking to a patient, friend or family member with MS. Even with training and awareness of the disease, we often blurt out something we think is innocuous only to find out later that we have deeply offended. The Health Activists that Extrovertic spoke to had some suggestions for having positive conversations with someone with MS.

2013 Hall of Fame Inductees

An entertaining look at the extraordinary lives and careers of the Medical Advertising Hall of Fame's 2013 inductees: Peter Frishauf, Dorothy Philips and David Labson. Clips produced by JUICE Pharma.

Slideshows

Peter Frishauf, founder of Medscape, delivers his acceptance speech.

MAHF 2013: Honors Class

A gallery of images from the 2013 Medical Advertising Hall of Fame induction dinner

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