BioCentury
ARTICLE | Politics & Policy

BIO, PhRMA lay out principles for off-label communications

July 27, 2016 7:00 AM UTC

In a set of joint principles, BIO and PhRMA emphasized that companies should be able to communicate "truthful, non-misleading" information outside of an FDA-approved label to insurance providers, PBMs and government healthcare programs as they consider reimbursement decisions.

According to the principles, a company should be able to describe to payers its pipeline, the status of FDA applications, the anticipated uses of products, relevant clinical trial data, pharmacoeconomic information and applicable treatment guidelines. A company should be able to discuss analyses of real-world data derived from "sound and well-described" research methods, the principles said. ...