Friends of Cancer Research hosted a panel discussion on Capitol Hill on February 24 focusing on challenges in the Food and Drug Administration's medical product approval process. Ellen Sigal, chairperson and founder of Friends, said that while she believes the FDA is doing a very good job, there's room for improvement. “Is there a more efficient way, because the goal is to get patients better treatments," she added. Friends proposes establishing Centers of Excellence at the agency, a disease-oriented approach to product regulation. As a result of advances in cancer research in addition to the Precision Medicine Initiative and the Cancer Moonshot, Friends suggests the FDA start with oncology as the pilot, then move on to other disease types such as neurodegenerative, cardiovascular and infectious disease.
Mark McClellan, M.D., Ph.D., director of the Duke-Robert J. Margolis Center for Health Policy at Duke University and former FDA commissioner, explained that over the years, the FDA has found that more products don’t fit their current structural arrangement. While the agency has taken extraordinary steps in the past to adjust to the new landscape, it is time once again to consider a more systematic approach to approving new medical products, especially as more combination products come into play. Steve Galson, M.D., M.P.H., Senior Vice President of the Global Regulatory Affairs and Safety division at Amgen Inc., noted that the review of combination products is one of the biggest challenges for FDA.
Otis Brawley, M.D., chief medical officer and vice president of the American Cancer Society Cancer Action Network, described how medical science has evolved, particularly in the field of cancer, over the past two decades with progress in genomics. Given that “we live in a time where the science has never been better,” it also is “showing us the complexity of what we’re dealing with,” said George Demetri, M.D., director of the Ludwig Center at Harvard’s Medical School. “Cancer is not one disease; cancer is thousands of different diseases,” requiring efficiency to ensure FDA's resources are not duplicated or wasted.