Monday, February 20, 2012
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).