Abstract

Objectives

To assess whether early-stage funding from the National Institutes of Health (NIH) should influence pharmaceutical pricing policy, particularly in the context of recent federal proposals linking public research support to drug affordability mandates.

Methods

We conducted a targeted literature review of peer-reviewed publications, government reports, and policy documents. This was supplemented by discussions with former NIH leadership to understand the rationale behind NIH’s role in drug development and pricing policy. The review prioritized conceptual breadth over comprehensiveness. These data were then used to inform a policy analysis evaluating the implications of NIH-related pricing interventions on innovation incentives and public-private collaboration.

Results

Our analysis reveals that, although NIH plays a crucial role in early-stage research, private industry contributes the majority of investment, risk, and infrastructure required to bring medicines to market. Policies such as the Bayh-Dole Act and related technology transfer frameworks were designed to leverage private sector capabilities, not to enforce pricing controls. Economic studies indicate that the societal surplus from drug innovation overwhelmingly benefits patients, with manufacturers capturing only a small share of total value. Historical experience with government-imposed “reasonable pricing” clauses discouraged collaboration and was ultimately repealed. Recent proposals to revive such clauses or allow price-based march-in rights may deter private investment and undermine innovation.

Conclusions

Drug prices should reflect value-based assessments and incentives for future innovation, not be adjusted retrospectively based on NIH involvement. Efforts linking pricing to public funding risk distorting the public-private partnership that has made the United States the global leader in biomedical innovation.