Category Archives: Legal

Attacks on FDA’s Aggressive Stance: Off vs. On-Label

Many manufacturers and industry watchers have recently renewed their challenges to the constitutionality of FDA’s expansive interpretation of off-label promotion on First Amendment grounds. Par Pharmaceutical Companies, Inc.’s recent lawsuit asked the courts to provide specific instruction and relief from prosecutorial threat for on-label communications to specific audiences who may also use their drug off-label. This is the latest in a series of attacks on the government’s aggressive stance on prosecution of pharmaceutical and medical device manufacturers and their executives for off-label promotion. Continue reading

New Lawsuit Chips Away at FDA’s Unwritten Off-Label Rules


Par Pharmaceutical, Inc. filed suit on October 14, 2011 to curtail prosecutions for off-label promotion based solely upon the physician specialties to which pharmaceutical manufacturers market their products.  In short, Par wants to promote its AIDS-related wasting drug, Megace ES®, for on-label uses but to physician specialties in long-term care and oncology settings that would likely use it predominantly for off-label indications.

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Medical Devices: The New Low-Hanging Fruit for Healthcare Fraud?


A highlight from the 7th Annual Medical Device and Diagnostic Compliance Congress in June was the talk by Jeremy Sternberg, deputy chief of the healthcare fraud unit, U.S. Attorney’s Office for the District of Massachusetts. His succinct and compelling story to medical device manufacturers, sales agents and distributors can be summarized as: We are smarter than ever (thanks pharma!), and we are coming after the new low-hanging fruit: medical devicesContinue reading

3 Risk-Benefit Tips for DTC Websites from FDA Studies


Just recently, the FDA gave us a hint of how they are currently thinking about fair balance and risk information when using websites to advertise.

On April 28, 2011, the FDA proposed and requested comments on three studies to test different ways of presenting benefit and risk information in online direct-to-consumer (DTC) prescription drug websites.  While the comment period is now closed, here’s a summary: Continue reading

Patient’s View on Actimmune CEO Sentence

Guest Author: Mike Henderson

What about the patients? That was my first thought when I read of Scott Harkonen’s sentencing  for misleading investors about InterMune’s drug Actimmune.

As CEO of biotechnology company InterMune, Harkonen published an outright lie, claiming that this drug “reduces mortality by 70% in patients with mild to moderate disease.” He did this after a Phase II clinical trial proved otherwise. He did it to drive up InterMune’s stock price, and it worked for a while. The company aggressively marketed this drug on an “off-label” basis through 2006. Continue reading