Senate releases draft bill seeking expanded accelerated approval

The U.S. Senate's Health Labor and Pension Committee released a discussion draft of the Drug Approval and Patient Access bill that would expand FDA's use of accelerated approval and Fast Track designation. The bill includes provisions from the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act and the Advancing Breakthrough Therapies for Patients Act (see BioCentury, March 12).

The TREAT provisions would encourage FDA to use its Fast Track authority more broadly to expedite drug development and would give the agency authority to grant accelerated approval based on clinical endpoints in addition to surrogate markers. TREAT provisions omitted from the proposal include a requirement for FDA to inform drug sponsors of the reasons for the non-approval of a drug application and a provision establishing a chief innovation officer and other new positions at FDA. ...