Political Quotes

“While well-intentioned, this motion to recommit falls short of providing vulnerable patients full access to experimental treatments. Providing clarity on how negative side effects will be accounted for during drug approvals is helpful. Giving manufacturers, sponsors, physicians, hospitals, and clinical investigators certainty on liability protections is meaningful. Taken together, these improvements to the existing expanded access program could lead to enhanced manufacturer and sponsor participation and increased patient access. But this would not provide an alternative pathway for patients who cannot get into a clinical trial and have been rejected from participation in the existing compassionate use program. This bill before us today does provide an alternative pathway, one that strengthens patient protections with clearer informed consent and real-time adverse event reporting. This bill--the underlying bill--also makes certain that the FDA is notified when a patient receives an unapproved drug through the new alternative pathway to ensure proper oversight. These are significant patient protections. With this motion to recommit, we have a choice. The underlying bill is the only choice that gives those patients in the greatest need of help access to investigational drugs, with their consent, even after they were rejected from participating in a clinical trial or expanded access. Mr. Speaker, the choice is clear. We need to vote to expand patient access.…”