Category Archives: Legal

The Rx Firm Tax Exodus: Is Something Wrong with the U.S. System?

As I read the latest reports of yet another big US Rx firm, this time AbbVie, trying to pull off a “tax inversion” takeover of the Irish-based Shire, I couldn’t help but wonder, what the heck is going on here? Right now, it feels like most major US corporations, especially pharmas, are literally running away […]
Also posted in Deals, Europe, Global, Guest Blog, Op-Ed, Strategy | Tagged , , , , , , | Leave a comment

Abrams Talks Social Media at DIA

“It doesn’t turn me on to send a warning letter.” –Tom Abrams, during a Q&A at DIA.  Instead of repeating his yearly Drug Information Association (DIA) conference claim that social media guidance remains among the FDA’s Office of Prescription Drug Promotion’s (OPDP) “highest priorities,” to be published in due course, Tom Abrams, director of OPDP, […]
Also posted in Advertising, E-Media, FDA, Marketing, Meetings, Patient Communication, Regulatory, social media, Strategy, Technology | Tagged , , , , , | Leave a comment

What Does ‘Off Label’ Mean in 2014?

by Tom Norton Years ago, while sitting in an Rx company lunch room, I was listening to one of the company’s top sales reps discuss the commercial progress a recently launched prescription was making. The rep said that the product was selling “OK” under its FDA approved, indicated therapeutic area. However, he quietly said, “It’s […]
Also posted in Biotech, FDA, Guest Blog, healthcare, Market Access, Marketing, pricing, Regulatory, Strategy | Tagged , , | 1 Comment

Obamacare's "Unacceptable" Rx Copays

by Tom Norton We are now approaching the six month point in the implementation of the new Obamacare program. It’s senseless to go into the good, bad and ugly of this new program. While much of the concept continues to be thrashed about in the political arena, in terms of actual medical results the truth […]
Also posted in Biotech, Guest Blog, healthcare, leadership, Market Access, Strategy | Tagged , , , , , , , | 2 Comments

FDA Takes First Amendment Issues "Seriously"

Several legal cases have challenged the Food and Drug Administration’s approach to regulating industry communications about medical products, and agency officials now are acknowledging the importance of addressing these developments head-on. In the wake of U.S. v. Caronia and IMS v. Sorrell, the spotlight is on speech-related activity, including product labeling and advertising and promotion […]
Also posted in FDA, Op-Ed | Tagged , , , | Leave a comment
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