Here's an interesting 1st Amendment Rights development:
MRK:
"FDA to hold public meeting on off-label drug promotion" • 11:13 AM
Douglas W. House, SA News Ed...
"Spurred by the progress of a bill moving through Congress that will speed new drugs to market for conditions lacking cures, called The 21st Century Cures Act, the FDA has scheduled a public meeting this summer to address concerns by the drugs industry that regulatory restrictions on what they can say about the off-label use of their products violates their First Amendment right to free speech. Language in the bill is ratcheting up the pressure on the agency to relax its guidelines.
Drug makers were emboldened on its prospects of changing the rules after an appeals court overturned the conviction of a pharmaceutical sales representative in 2012 who was convicted of promoting off-label uses of the narcolepsy drug Xyrem. The court ruling was based on First Amendment protection for truthful and non-misleading off-label speech.
The American Medical Association supports the need for physicians to have access to accurate and unbiased information about off-label uses of drugs since it already accounts for as much as 20% of prescribing, with higher levels in oncology and pediatric rare diseases.
Giving drug firms more leeway in this arena has its detractors, however. Rita Redberg, M.D., Professor of Medicine at the UC-San Francisco says, "At my own medical center we have banned pharmaceutical reps from coming because we don't think they are a good source of information. You don't ask the barber if you need a haircut."
Pharma companies have a dubious history of breaking the rules governing off-label promotion. Over the past 10 years, 17 firms have paid more than $16B in settlements related to inappropriate off-label selling.
Further complicating matters is the fact that up to 75% of published pre-clinical trial results cannot be reproduced in later studies."
I completely support any action on the part of Amarin that legitimately exercises their 1st Amendment rights, but unfortunately they haven't shown any desire to step outside of their box.
