Category Archives: Corporate Responsibility

Good Policy: The Victim of 'Good Works'?

By Guest Blogger | Published: August 29, 2012

By Susan Crowley Public policy activities should be a distinct, mission critical function for Big Pharma — our business depends increasingly on government as a key customer. However, as companies confront the necessity to plump up the bottom line as patents expire, staffing of non-line functions has taken a big hit, with policy advocacy work emerging [...]

Also posted in Guest Blog, Op-Ed | Tagged corporate social responsibility, philanthropy | Leave a comment

As American as Acid Reflux

By Ben Comer | Published: August 21, 2012

Over the counter drug advertising is less regulated than prescription drug marketing, and selling directly to consumers comes with the benefit of bypassing an expert middleman: your doctor. But companies should still promote with caution.

Also posted in Advertising, E-Media, FDA, Market Access, Marketing, Regulatory, Strategy, healthcare, leadership, patient education | Tagged Agency, celebrity, Consumer Advertising, Marketing and Advertising, OTC, Publicis | 1 Comment

Forest Labs Hit with Bad Ad Tattle

By Ben Comer | Published: August 7, 2012

Forest Labs has had a tough time with regulators over the last two years. The company’s sales reps can’t seem to stop breaking the law. The latest offense, which generated an Untitled Letter from the Office of Prescription Drug Promotion (OPDP), was brought to light through OPDP’s Bad Ad program, which encourages physicians to report on [...]

Also posted in FDA, Legal, Marketing, Regulatory, Sales, compliance | Tagged Bad Ad, compliance, off-label, OIG, OPDP, Regulatory, Sales Reps, Untitled Letter | Leave a comment

Missed Opportunities in Rare Disease

By Ben Comer | Published: July 20, 2012

At CBI’s 7th Annual Rare Disease and Orphan Drug Leadership Congress, speakers and attendees identified areas where pharma can improve the way it approaches rare disease and treatment.

Also posted in Events, Market Access, Regulatory, leadership, patient compliance, patient education | Tagged CBI, orphan diseases, Orphan Drugs, rare diseases, REMS | Leave a comment

Comply or Die: Introducing GSK's New Corporate Integrity Agreement

By Ben Comer | Published: July 6, 2012

Big pharma talks a lot about the changing business model and placing a new emphasis on patients, but the fact remains that quantity of medicines sold, not quality of care provided, is how to get paid (and how to keep investors happy). Despite its egalitarian trappings, the healthcare “ecosystem” is still dominated by the [...]

Also posted in Agency Insight, Legal, Marketing, Regulatory, Sales, Strategy, compliance | Tagged CIA, Corporate Integrity Agreement, DoJ, False Claims, fraud, GlaxoSmithKline, GSK, HHS, Justice Department, Office of Inspector General, OIG | Leave a comment