"We cannot rest on our laurels. We have an obligation to periodically reevaluate and adjust to account for the sweeping changes in the health sector."
"the incentives are clearly not there to drive the innovation we need for many of the conditions."
"In a biosimilars provision in the Affordable Care Act, we gave 12 years of exclusivity to biologics."
"I have always believed that the 7 years was too long."
"Well, you mentioned the evergreening provision in your testimony."
"This MODDERN Cures proposal, the sponsors point out it is only for therapies that address an unmet medical need for serious or life-threatening diseases."
"And that could be a huge windfall?"
"Well, it is important that we insist on receiving more information as we look at this law because this is a huge windfall in some cases, and we want to know if it is necessary."
"Bob has been an advocate for consumers throughout his career."
"His expertise, experience, and dedication will continue to benefit the agency and consumers in a second term."
"I continue to believe that Fast Track is a worthy program that needs to be improved."
"I greatly respect and admire Ms. Brown, and I agree with her that Fast Track is an excellent program."