Off-label communications, properly done, advances precision medicine, delivering speedier positive patient outcomes, and reducing costs to our healthcare system. Off-label communications provides patients with more options for effective medicines.
Those who think that the argument over off-label is just about marketing and sales are looking at this issue through very narrow blinders.
So, what do academics and physicians, payers and patients know about off-label communications that the FDA does not? Asked in a more progressive way, how can the FDA be an accelerator rather than a sea anchor when it comes to facilitating off- label communications?
In a word, the answer is clarity. Alas, regulators love ambiguity because it gives them unlimited options. And nowhere is this more evident than when it comes to issues concerning communication.
It would be generous to call the FDA’s views on the dissemination of off-label information ad hoc. With the important exception of the agency’s guidance on Good Reprint Practices (http://sco.lt/4k2s7t).
Beyond this, what will the FDA do next? More importantly, will it lead or follow, or follow and then lead? Can the FDA recapture a leadership role in the off-label conversation? I believe it can – and will. But it will require the agency to trade ambiguity for predictability because, when it comes to trustworthy off-label communications, predictability is power in pursuit of the public health.
When it comes to off-label communications, Priority #1 is FDA leadership though bold action and clarity.
This is urgent for many reasons: different federal agencies (FDA, FTC, DOJ) with differing views on pathways and jurisdiction, and the extreme danger of allowing federal judges dictate regulatory policy. If existing policy has evolved to protect the public from snake oil, the Amarin decision is precarious precedent for communications about fish oil – and beyond.
Nature abhors a vacuum and, absent strong and forward-looking FDA leadership, the off-label debate will result in public health chaos.
And, as many management gurus have written, one of the key tenets of successful leadership is the ability to delegate in order to get things done.
To that end, one policy alternative is for the FDA to pursue a strategy that embraces third-party sanctioned communication -- a more intramural approach based on the FDA’s partnering with an external entity charged with accrediting certain types of communication (read, for example, "We're Here to Help You Vet Off-Label Information”; http://sco.lt/5Yk0Jt).
Things are moving fast and unless the FDA acts, we’ll have federal judges making these decisions for us (http://sco.lt/77gqO1). That’s not good for the FDA or the public health.