Anyone who thinks that the argument over off-label communications is just about marketing and sales is looking at the issue through very narrow blinders. Off-label communications recognizes that the speed of scientific discourse impacts clinical practice years before it drives official label changes.
The key impact of 2012’s precedent-setting Caronia ruling is that, according to the court, the First Amendment protects truthful and non-misleading off-label speech.
Truthful + non-misleading = trustworthy adds up to a good off-label equation.
After Caronia the FDA issued valuable draft language: It would “not object to the distribution of new risk information that rebuts, mitigates or refines risk information in the approved labeling.” But it must be “well designed” and “at least as informative as the data sources” that the FDA used in generating the official warning.
The same court that ruled in Caronia ruled in favor of Amarin’s using truthful off-label information for physician communications.
What happens now?
I predict that the FDA will issue updated draft guidance and collect feedback via the Federal Register. Barring overly ambiguous language, most pharmaceutical companies will declare victory—but the agency will need to carefully monitor its off-label oversight. This means more than the usual and customary review by the Office of Prescription Drug Promotion. It means the attention of senior management trained on how the agency defines “trustworthy” and keeping a prudent eye open.
The FDA can recapture the leadership role in the off-label conversation, but it will require trading ambiguity for predictability. When it comes to trustworthy off-label communications, predictability is power in pursuit of the public health.
Off-label communications is now on the agency’s front burner and the flame is on high. As late Sen. Everett Dirksen (R-IL) used to say, “When I feel the heat, I see the light.”