As you well know, off label communications is on my short list of regulatory policy and public health issues that keep me up at night.
Why? There is a leadership vacuum on the topic, and absent clear leadership, federal judges are starting to dictate regulatory policy through the Amarin case and others. If existing policy has evolved to protect the public from snake oil, the recent Amarin decision is precarious precedent for communications about fish oil – and beyond.
To help find better, collaborative solutions to this important issue, on February 18th the new Duke-Margolis Center for Health Policy held a conference titled, “Off Label Communication in 2016: Meeting Information Needs through New Policy Options.”
Those new options are detailed in an important new paper:
Policy Options for Off-Label Communication: Supporting Better Information, Better Evidence, and Better Care
I am honored to be one of the co-authors and to have had the opportunity to speak at the event.
Just about every speaker pointed to the need for FDA leadership though bold action and … clarity. The paper lays out what we refer to as Guiding Principles for Lasting Solutions. They are:
- Promote well-informed clinical decision-making to improve public health.
- Support FDA’s central role in reviewing, approving, and enforcing efficacy claims.
- Reduce inconsistencies across agencies’ enforcement decision-making.
- Avoid continued cycles of litigation through greater policy clarity.
- Promote more evidence development and data submission to FDA.
Nature abhors a vacuum. All of the participants in the conference and all the authors of the white paper were in complete agreement that absent strong and forward-looking FDA leadership, the off-label debate will result in public health chaos.
Peter J. Pitts is an authority on global regulatory policy issues and an Executive Partner at YourEncore. He is a former FDA Associate Commissioner, the Chief Regulatory Officer for Adherent Health Strategies, and the President of the Center for Medicine in the Public Interest, a policy institute he founded in 2004.