Following last week’s announcement that Johnson & Johnson will create an independent panel for compassionate use requests, Rep. Michael McCaul (R-TX) spoke out in support of the action.
“Today’s announcement is a clear example of how Johnson & Johnson is a leader on the issue of expanded access for patients with life-threatening diseases and conditions,” McCaul said. “While Congress is still working to improve the expanded access process at the (Food and Drug Administration) FDA, I am encouraged by this unique partnership with (New York University) School of Medicine’s Compassionate-Use Advisory Committee.”
The issue is of particular importance to McCaul, who has for many years been a champion and a Congressional leader on the need for compassionate use reform. The Congressman hosted a Childhood Cancer Summit in Washington, D.C., last year, during which Johnson & Johnson’s Chief Medical Officer Dr. Amrit Ray spoke about the issues surrounding compassionate use.
McCaul led the introduction this year of the Andrea Sloan Compassionate Use Reform and Enhancement (CURE) Act, legislation that would make critical changes to the compassionate use and expanded access process used by the FDA to give seriously ill patients the right to learn about innovative treatment options and the policies of the pharmaceutical companies developing them.
“This partnership should demonstrate to patients that companies are taking seriously the need to balance patient’s interests with the highest ethical standards,” McCaul said. “I look forward to seeing how this arrangement will develop and how it might serve as a model for other companies in the future.”