In his first address to Congress, President Trump drew the chamber's attention to a young woman in the audience, Megan Crowley, a survivor of Pompe disease, and her father, John. Megan is alive today—and a student at the University of Notre Dame—because, in the absence of a cure, her father founded a biotech company to find one. The president told their story to highlight the urgency of reforming the drug-approval process at the U.S. Food and Drug Administration (FDA), which has become so costly and cumbersome that it risks preventing the development of lifesaving treatments. John Crowley, in addition to his work in the biopharmaceutical field, has become an advocate for policies that can speed up the development of drugs, vaccines, and diagnostic tests for rare and neglected diseases. Manhattan Institute scholars, through Project FDA, explain the policies needed to modernize the FDA, including rigorous research and development that allow for a sustainable profit, a streamlined clinical trial process, and rapid innovation based on near-instantaneous feedback from patients and physicians.

On July 12, we had the pleasure of welcoming John F. Crowley to the Young Leaders Circle. He is chairman and CEO at Amicus Therapeutics and a founding board member of the Global Genes Project. As a veteran of the global war on terrorism, Crowley served as a commissioned officer in the U.S. Navy Reserve, assigned to the United States Special Operations Command. He and his family have been profiled on the front page of the Wall Street Journal and are the subjects of the book The Cure: How a Father Raised $100 Million—and Bucked the Medical Establishment—in a Quest to Save His Children. The major motion picture Extraordinary Measures, starring Brendan Fraser and Harrison Ford, is inspired by the Crowley family's journey. Crowley holds a B.S. in foreign service from Georgetown University, a J.D. from the University of Notre Dame Law School, and an M.B.A. from Harvard.