Richard Burr: “My question was simple, Mr. Secretary. At what point will we determine whether what we have implemented is working?”

I question whether the agreements both passed and proposed reflect a good deal for patients they are designed to serve.

More than 278 therapies have been approved under the accelerated approval pathway over the 30 year history, saving and improving thousands of lives.

Ms. Kotagal's refusal to continue these common-sense measures speaks volumes of her lack of commitment to due process and transparency.

It is time that we hold the FDA accountable.