RAPS: BIO Calls for Increased Emphasis on Patient Perspectives by Biopharma, FDA

Biopharmaceutical companies should seek out and incorporate the perspective of patients earlier on in the drug development process, a new white paper from the Biotechnology Industry Organization (BIO) argues. The call comes in the midst of a sustained shift by both companies and regulators to incorporate the views of patients into the regulatory process. Starting in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA has begun to meet with more than a dozen patient groups in the hopes of better understanding the diseases afflicting them and the risks of a drug they would be willing to tolerate in return for specific benefits.