Sen. Kay Hagan and collaborators at BIO have backed off from proposals that could have fundamentally changed new drug approval criteria, opting instead to use the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act to push FDA to aggressively expand its use of accelerated approval to a wider range of indications and trial designs.

Under withering criticism from FDA, large pharmaceutical companies and PhRMA, Hagan (D-N.C.) left on the cutting room floor early draft proposals to create a new progressive approval pathway and a new "exceptional approval" mechanism FDA could use to waive normal approval requirements if it isn't feasible or practical to generate data legally required to demonstrate safety and efficacy (see BioCentury, Nov. 14, 2011).