The US Food and Drug Administration (FDA) issued a draft guidance document on payor communications, in the final days of the Obama administration. Drug and Device Manufacturer Communications with Payers, Formulary Committees, and Similar Entities – Questions and Answers, addresses two topics:
- Communication of HCEI by drug manufacturers to payers regarding FDA-approved drugs, and
- Communications by drug and device manufacturers regarding investigational products.
Find out more on these topics here. (Source: Vernessa T. Pollard, Paul Radensky, MD, Veleka Peeples-Dyer, Anisa Mohanty, The National Law Review, 1/31/17)