Communication Guidelines for Drug Manufacturers Issued by PhRMA and BIO
Friday, July 29, 2016
Posted by: Stephen Rapundalo
Two national industry groups, Pharmaceutical Research & Manufacturers Association (PhRMA) and Biotechnology Innovation Organization (BIO), issued a set of guidelines aimed at improving communication between pharmaceutical companies, payers and health care professionals about drug products.
The guidelines call for the FDA to clarify the types of information biopharmaceutical firms are allowed to share. They contain nine principles focused on providing appropriate context about data, representing data accurately and commitments to science-based communications.
Development of the guidelines by PhRMA and BIO arose because of the lack of clarity around how much communication drug makers and insurance plans can have about treatments and therapies. So-called “safe harbors” to share information outside of FDA-approved labeling are very limited currently.
With the increased focus on drug pricing, the industry groups are advocating that biopharma companies should be able to share certain information with insurance providers, pharmacy benefits managers and government health programs, so that they’re better informed when considering the potential costs of new medicines.
The guidelines come in part as a response to patients, caregivers, health care professionals and insurers, who want more information about the safety, effectiveness and value of treatments against a backdrop of data-driven medicine.