Political Quotes

“Andrew McFadyen said: Dr. Delpassand claims to have used right to try because FDA would not allow him to do expanded access. And this was for a very good reason. FDA placed a clinical hold on a study, due to the fact that his clinic was not reporting serious, adverse events, as required; and he continued to enroll patients, despite the clinic hold. The work of Dr. Delpassand's study was associated with 40 deaths and 2 hospitalizations. FDA's clinical hold on Dr. Delpassand's work is a sign to me that FDA's expanded access pathway was working to prevent bad actors from continuing to expose vulnerable patients to experimental treatments. Mr. Speaker, H.R. 5247 is dangerous for our patients. It is an unprecedented attempt to roll back the FDA's oversight of investigational treatments. I urge my colleagues to stand with more than 100 organizations that have come forward to oppose this misguided and, I believe, harmful legislation. Mr. Speaker, I reserve the balance of my time.”