Patient and physician groups, including the American Society of Clinical Oncology, Friends of Cancer Research, American Lung Association, Cystic Fibrosis Foundation, and National Organization for Rare Disorders, voiced their opposition in a May 21 letter to House Republican and Democratic leaders.
“The Senate version of the legislation is less safe than the pathway proposed in the House version and is dangerous compared to the current [FDA] expanded access program,” according to the groups. “Both House and Senate versions would also remove FDA’s consultation on dosing, route of administration, dosing schedule, and other important safety measures available under FDA’s current expanded access program.”
The organizations noted that, while they did not support the House version, it “includes improved patient safeguards compared to the Senate version. The Senate version would negatively impact patient safety substantially, and our collective organizations are strongly opposed.”
President Trump has signaled he will sign the bill.