For millions of patients across the United States and around the world, the status quo often represents death or serious disability. The promising pipeline of engineered cell therapies and genetic medicines to durably treat and potentially cure devastating diseases brings hope to these patients and their families.
The FDA represents the gold standard for determining the safety and efficacy of medicines for patients through a scientifically rigorous analytical process. As the global voice of the cell and gene therapy sector, ARM believes courts lack the technical expertise to second-guess the FDA’s scientific and medical judgment. To support the development of new treatments, patients, researchers, and product developers need to have confidence that courts will not arbitrarily upend the Agency’s long-established, highly regulated process.