Using Off-Label Communications to Responsibly Advance the Public Health

The debate over off-label communications doesn’t begin or end with the Caronia or Amarin decisions. It’s a continuing dialogue between manufacturers and the FDA, between doctors and patients, between doctors and academics, between lawyers and judges, and between advocates on all sides. And the red thread that ties these conversations together is responsible off-label communications. Not sales strategies. Not Direct-to-Consumer (DTC) advertising and marketing tactics. Not managed market negotiations—the responsible sharing of truthful and accurate information via nonregulated speech. Off-label communications, properly done, advances precision medicine, delivering speedier positive patient outcomes and reducing costs to our health care system. Off-label communications provides patients with more options for effective medicines.