US Senate passing of FDA Safety and Innovation Act lauded by biotech and pharma industry

The US Senate approved the Food and Drug Administration Safety and Innovation Act (FDASIA), which includes a reauthorization of the Prescription Drug User Fee Act (PDUFA), last Thursday, in a move welcomed by both the Biotechnology Industry Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA).

BIO president and chief executive Jim Greenwood commented: “The inclusion of an enhanced Accelerated Approval pathway, crafted by Senator Kay Hagan (Democrat, North Carolina), will help expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases while preserving the FDA’s robust standards for safety and effectiveness.

He continued: “FDASIA also enables a transparent, predictable and balanced regulatory framework for the review and approval of biosimilars by establishing reasonable performance goals and dedicated, independent funding for biosimilar review activities. This will allow the FDA to continue to prioritize the review of innovative drugs and biologics so that safe and effective new therapies – many for currently serious, untreatable diseases – can be available to the patients who need them.