BIO Call for Predictable, Pro-innovation Federal Policy in Response to OSTP RFI

In a detailed response to the White House Office of Science and Technology Policy (OSTP), the Biotechnology Innovation Organization (BIO) urged federal policymakers to strengthen the U.S. scientific enterprise by restoring predictability, modernizing research funding, and reinforcing public-private collaboration across the biomedical innovation pipeline. 

Submitted in response to OSTP’s Request for Information on policies to accelerate American science, BIO’s comments reflect growing concern across the life sciences sector that policy uncertainty - rather than scientific risk - is becoming a major barrier to long-term investment, translation, and competitiveness. BIO emphasized that drug discovery and development require extended timelines, significant capital commitments, and durable partnerships, all of which depend on stable federal policy signals. 

Modernizing Federal Funding and Partnerships 

At the core of BIO’s response is a call to modernize federal research funding mechanisms so they better reflect the realities of biomedical innovation. BIO advocates for sustained, multi-year investments in use-inspired basic and translational research, flexible milestone-driven funding structures, and expanded tools—such as predictable R&D tax incentives and co-investment models—that help de-risk early-stage science and crowd in private capital. 

These recommendations align with broader national analyses warning that fragmented funding and short-term budget cycles undermine the return on federal research investments. Recent reports from the National Academies and the Council on Competitiveness have similarly highlighted the importance of continuity and scale in federal science funding to maintain U.S. leadership in innovation-intensive sectors. 

Strengthening Medical Countermeasure and Biodefense Readiness 

BIO also underscored the need to better coordinate the nation’s medical countermeasure (MCM) enterprise, particularly through more effective operationalization of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). Drawing on lessons from Project BioShield and BARDA, BIO emphasized that predictable demand signals, aligned interagency coordination, and multi-year procurement authorities are essential to sustaining private-sector engagement in areas where commercial markets are limited or uncertain. 

These concerns echo findings from recent Government Accountability Office (GAO) reviews, which have noted that gaps between early-stage research, advanced development, and procurement continue to slow MCM readiness and discourage sustained industry participation. 

Translation, Manufacturing, and Regulatory Efficiency 

Beyond funding, BIO’s comments highlight structural barriers that slow the translation of discoveries from lab to market. The organization calls for modernized technology transfer policies, incentives to strengthen domestic biomanufacturing capacity, and streamlined administrative processes—such as faster execution of CRADAs and MTAs - to accelerate collaboration between industry, academia, and federal labs. 

BIO also reinforced the importance of maintaining the FDA as the global gold standard for regulatory science. Recommendations include reducing administrative burdens in clinical trials, advancing new approach methods to reduce reliance on animal testing, and improving regulatory predictability to ensure the U.S. remains a preferred location for early-stage clinical development.  

These priorities closely mirror ongoing FDA and NIH initiatives to modernize clinical research infrastructure and regulatory science frameworks. 

A Broader Signal to Policymakers 

Taken together, BIO’s response sends a clear message: sustaining U.S. leadership in biotechnology will require more than breakthrough science. It will require coherent, predictable federal policies that align research funding, regulatory oversight, manufacturing strategy, workforce development, and innovation incentives around shared national goals. 

As OSTP evaluates feedback from across the scientific community, BIO’s recommendations reinforce a growing consensus among industry, academic, and policy leaders that the next phase of American scientific leadership depends on strengthening the connective tissue between discovery, development, and deployment - while ensuring that policy uncertainty does not become the weakest link in the innovation ecosystem.