The United States has long been the global leader in biomedical innovation but antiquated regulatory processes now put that leadership at risk. Most urgently, outdated regulatory requirements and unnecessary compliance burdens in early-phase research are driving promising programs overseas, particularly to more streamlined frameworks, such as Australia and China. The same procedural burden that pushes programs offshore also keeps therapies from patients with the least ability to wait: those with rare or fast-progressing diseases for whom there will be no large trial, whose treatments often begin in an academic lab or small biotech company and stall in a process that was not built for them. Many of these rules have not caught up to the science they govern, leaving regulators with fewer tools than the work requires.

This paper presents 12 targeted, commonsense reforms organized across five thematic areas: trial initiation and early-phase development, methodological flexibility and evidence generation, individualized therapies and cross-program learning, review process predictability and international coordination, and development incentive sustainability.

Together these reforms preserve the gold-standard requirements of the Food and Drug Administration (FDA) for safety and efficacy by clarifying expectations, equipping the agency with modern tools, and building a regulatory structure needed for the next generation of individualized therapies. By reducing red tape and promoting workable frameworks, these proposals would meaningfully lower development costs and help deliver better treatments to patients faster.

Some of the proposals that follow are new. Several have already been put forward, in one form or another, by lawmakers in both parties, by the current and prior administrations, or other stakeholders across the ideological spectrum. That convergence is the point of the paper: identifying ideas capable of commanding support across the aisle. All of them are worthy of bipartisan support.

Some would require action by Congress, others the FDA can implement under its existing authority. This paper is not intended as a comprehensive account of everything that could or should be done at the FDA. It is a set of policies chosen because they should be able to command support across the political spectrum and because they would legitimately strengthen the American biopharmaceutical innovation ecosystem and help patients gain faster access to life-saving and life-changing treatments without sacrificing safety and efficacy.