Pallone’s Bill Gives FDA New Power Over Accelerated Approvals

House Energy & Commerce Committee Chair Frank Pallone (D-NJ) unveiled a legislative plan to reform FDA’s accelerated approval pathway by giving the agency power to withdraw approval status if required postmarket studies aren’t completed within five years. Pallone’s bill, introduced Monday (March 7), also requires postmarket studies be planned out and initiated before FDA approval. The accelerated approval pathway has been a major focus of lawmakers and policy watchers over the past year, spurred by FDA’s controversial approval of Biogen’s...