This week a federal appeals court ruled that off-label drug marketing is protected free speech.
The ruling is somewhat controversial, with supports and detractors. Some claim the ruling is a triumph for free speech. Others argue that the ruling will allow the prescription drug industry to promote drugs without restrictions.
The pharmaceutical industry is a complicated world. Doctors are allowed to prescribe FDA-approved drugs however the wish, but drug makers are only allowed to market and promote the drug for the specific FDA-approved marketing indication.
Dr. Silverman Comments
I find it ridiculous when I am talking to a rep from a company about a drug and I ask, “Can I use it for this related problem?” and the answer is “I am sorry, we can’t discuss that, it’s off-label.”
Even when the company is compiling literature and doing research, I can’t request it from the drug or company rep, I have to make a formal request to the company, sign a form that I made this request and wait for an email regarding it.
It’s ridiculous. One of the most troublesome areas I find this with is in the pain management realm. Pain medicine for nerve pain can’t be talked about in all nerve pain types. I can use it off label, but the reps can’t even mention it.
How can we help patients when they come out with good, safer, non-narcotic, non-addictive drugs?
Related Sources:
Medpagetoday.com