I was shocked to see media stories saying DTC may expand to cover off label use. What! This erroneous idea came from an FDA open meeting held 11/16 to discuss off label use based on court cases allowing drug companies the right to discuss them. FDA has been under pressure on first amendment grounds to liberalize their restrictions on drug companies educating doctors and other learned players on off label studies.
As far as I know no one at FDA is seriously thinking of allowing drug companies to advertise off label use to the public through DTC. I know we are in an era of fake news but seriously folks. FDA goes nuts when the background music is too loud on DTC ads. Does anyone think they will allow drug companies to tout off label uses to consumers? No, they will not. Not even under free marketer Trump
The whole debate over off label is because courts have ruled drug companies can use commercial free speech to discuss studies reflecting off label uses. FDA is trying to figure out how to deal with the first amendment in regulating such uses. They have been strictly using approved label claims as the standard but drug companies want the right to tell the medical world about legitimate off label studies.
I do not think drug companies expect to carry this free speech argument to DTC. All they want is to be able to do is discuss such uses with medical professionals who would want to know that information. Can a detail rep tell a doctor about a study involving off label use? Can a drug company tout such off label uses in discussions with stock analysts? FDA has been quick to pounce on drug companies promoting off label studies to anyone. They fear misinterpretation and incorrect use. They might be justified in their concerns but also need to allow business speech that is fact based even if not yet approved in the label.
The lay press thinks that FDA might open the floodgates of off label use in DTC. A publication as reputable as Consumer Reports had a story 11/9/16 titled “FDA Considers Allowing Drug Ads for Unapproved Treatments.” I am not sure why Consumer Reports made the leap from possibly loosening the regulations for discussions with doctors all the way to DTC. That story seemed to be picked up by many news organizations who said drug ads may increase because of off label uses.
I think the FDA will take years to study this issue and not do more than the courts push them to do. They are just figuring out how drug companies can use the Internet about 20 years late. They are worried consumers will get confused figuring out how to click on the fair balance. So, I do not think off label use is on their list of DTC to do projects, not for a decade or two.