Comments on Legislative Discussion Draft, “Next-Generation US Clinical Development to Accelerate Cures”

Congress should preserve FDA’s authority over first-in-human studies rather than delegating oversight to pre-certified third parties, which would limit the agency’s ability to halt unsafe trials and introduce conflicts of interest where reviewers depend on sponsor funding. Early-phase development could instead be accelerated by standardizing FDA communications from the pre-Investigational New Drug (IND) stage onward, funding additional reviewers, and requiring mutual recognition of institutional review board (IRB) approvals across sites. Requirements that clinical data be generated in the US risk raising development costs and prompting other countries to impose reciprocal local data mandates.