I just received an email missive from Bob Ehrlich (@BobEhrlich_DTC), Chairman of DTC Perspectives, Inc., with the subject line “Media Misreporting Advertising Off-label Use.”
Ehrlich said “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.”
I first reported that the FDA was interested in hearing comments about off-label drug promotion to “patient and consumer audiences” back in September, 2016, after reading this in the Federal Register Notice (read “FDA May Have No Choice But to Allow Direct-to-Consumer Off-Label Drug Promotion” and find the notice here):
“To what extent is it appropriate for firms to communicate information about unapproved uses of their approved/cleared medical products to patient and consumer audiences [my emphasis]? What disclosures and additional information would be needed to help ensure that a communication to lay audiences is truthful and non-misleading, given consumers’ lack of medical training and expertise in critically evaluating this type of information?”
Obviously, Ehrlich did not bother to read the notice and only reads Consumer Reports, which published results of a survey it did on the topic and reported at the hearing. Regarding that, Ehrlich said:
“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.”
Yo! Bob! Consumer Reports may have got the idea from my blog post made two months BEFORE it published its story or maybe it did what a good news organization should do and actually read the FDA notice, which was pusblished in September, 2016.
Ehrlich may also have confused this LA Times opinion piece with a news story that was published just last week: “Off-Label Direct-to-Consumer Drug Advertising ‘Just Isn’t Healthy’“.
Ehrlich closed with this:
“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.”
He may be right about the timeline, especially after Trump signed an executive order that calls for government agencies to pull two regulations for every new regulation they implement. The FDA may just “sit on its hands” and issue no new regulations for a good long while and that will NOT be good for the drug industry (read “FDA Regulation Cutting Will Impact Drug Approvals Too“).