All Quotes

I have heard serious concerns that FDA is responding to some meeting requests with a 'written response only.'

We have had a great success, I believe, and we have got another agency of the Federal Government that just absolutely cut our legs out from under us.

I fear it will discourage research and have an impact on the pipeline of drugs.

What concerns me in this case is not FDA's approach. I think you stayed within your lanes.

I hope that we will be able to fill it.

Congress charged the FDA, not CMS, to be the agency responsible for evaluating the safety and efficacy of biomedical products.

In light of the decision by CMS, do you question the FDA's decisionmaking regarding Aduhelm's accelerated approval?

Could you please explain to the subcommittee how the Department can justify arguing in court that the pandemic has subsided enough to warrant the termination of Title 42?

In Maine, we set a horrific new record, 636 people died from drug overdoses.

This isn't like the Department of Agriculture or the Department of Commerce... We're it.

Are you willing to say no to the Director of the CIA, and the President of the United States?

A secret agency is an anomaly in a democracy.

I have never seen a better example of unjustified regulations, just completely unsupported by data.

The deadline really does need to be moved. Of course, myself, and most, well, all of the Maine delegation opposed the regulations to begin with.

Drug development is hamstrung by the fact that we simply do not have well characterized the endpoints for most rare diseases.

More than half of the 400 million people in the world who are affected by rare diseases are children, and about one-third of those children will sadly die before the age of five.

Dr. Esham accelerated approval is a critical regulatory pathway that provides timely review of treatments for patients with serious and life threatening conditions for which there is an unmet need.

I think we have got some sorting out to do on those questions and appreciate your insights.