Lawmakers plan accelerated approval bill

Reps. Cliff Stearns (R-Fla.) and Edolphus Towns (D-N.Y.) plan to introduce legislation as soon as next week that seeks to expand FDA's use of accelerated approval. The Faster Access to Specialized Treatments (FAST) Act is almost identical to the accelerated approval provisions in the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, which Sen. Kay Hagan (D-N.C.) introduced in the Senate in February (see BioCentury, Feb. 20).

The FAST and TREAT accelerated approval language was developed in close collaboration between Hagan's staff and the Biotechnology Industry Organization (BIO), with input from senior FDA officials. The bills state that it is the "sense of the Congress" that FDA "should apply the accelerated approval and fast track provisions to the greatest extent possible to help expedite the development and availability to patients of treatments for serious or life-threatening diseases or conditions while maintaining appropriate safety and effectiveness standards for such treatments." FAST, and the accelerated approval portions of TREAT, could be attached to legislation accompanying PDUFA reauthorization. ...