Evidence to inform biopharmaceutical policy: call for research on the impact of public policies on investment in drug development.

This paper highlights the pressing need for updated, robust evidence to inform biopharmaceutical policy, particularly in light of recent initiatives such as the Inflation Reduction Act. Current estimates that inform such policies, including those from the Congressional Budget Office, rely on outdated data and models that fail to fully capture the complexities of modern investment decisions or the broader impact of policies on drug development in areas like oncology, rare diseases, and vaccines. Understanding how expectations of financial returns influence investment in all stages of drug development is critical for evaluating these policies' long-term effects on innovation. This piece reviews the current evidence on the relationship between financial returns and research and development investment and considers how this evidence is being used to shape biopharmaceutical policy. It also highlights gaps in data and methodology, emphasizing the need for better models that reflect real-world trade-offs, investment risks, and therapeutic area-specific impacts. Finally, this paper calls for improved access to federal and private data to better inform evidence-based policymaking and to study policy impact on investments in the next generation of medicines, particularly in emerging fields like gene and cell therapies, where the implications of policy decisions are not yet fully understood.