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BLOG: Are off-label discussions about to be legal?
All of the men in the White family start their day off with the Wall Street Journal, and last week on Cape Cod the fact that three generations of us were together just meant we argued over who got it first. What? You thought just because I recently admitted that I read real scientific journals that now that’s all I read? Not a chance. In fact, all of the really fun stuff still shows up in places like the WSJ.
Anyway, I stumbled across something that could turn into a really big deal. You are certainly aware that your friendly neighborhood drug rep isn’t allowed to talk about anything that’s not specifically mentioned on the official FDA label. Never mind that most of the really cool stuff we use meds for was something discovered after the FDA trials and has little to do with the original indication. Think anti-VEGFs and diabetic macular edema, or baby aspirin and cardiac event prophylaxis. How cool would it be if we could hear about all of the data, all the indications that are both out there and squirreled away in some vault at pharma central?
Well, the times may be a-changin’. A federal district court in New York ruled in favor of the Irish company Amarin Pharma’s request to remove the FDA ban on off-label marketing. This comes on the heels of the 2013 exoneration of drug rep Alfred Caronia for off-label marketing of a narcolepsy drug. A federal appellate court ruled that such a ban would violate Mr. Caronia’s First Amendment rights, similar to the finding in favor of Amarin (the FDA did not appeal the Caronia decision). Two big decisions, two big precedents.
This could be a game changer. Think about how much more fun it will be to go to CME meetings and be able to hear everything about a med (not to mention how much more fun it will be to teach at those meetings). The court in the Amarin case said the only criterion is that the information about a drug be true. This is a dry eye blog. Think about all of the data out there on the use of AzaSite (azithromycin ophthalmic solution 1%, Merck) for meibomian gland dysfunction and evaporative dry eye. All true.
Somebody with some, ahem, guts could tell the truth about AzaSite and make it a half a billion dollar drug.
Disclosure: White reports he is a consultant for Bausch + Lomb, Allergan, Shire and Eyemaginations and on the speakers board for Bausch + Lomb and Allergan.