Safer harbor

FDA guidance released on June 12 clears up regulatory ambiguities that have restricted drug and device company communications with payers, physicians and patients. A primary goal is to make it easier to base payments on outcomes not mentioned on product labels, but there could be broader effects in the loosened restrictions on communications between medical product developers and payers.

If sponsors exercise the ability to discuss healthcare economic data before drugs are approved, that could prevent payers from being surprised by high demand, as they were for the HCV drug Sovaldi sofosbuvir from Gilead Sciences Inc. ...