Executive summary
In the wake of the election, the path forward on biosecurity is unclear, and a lot will depend on who ultimately leads the key federal agencies tasked with fighting infectious disease. And there are reasons for concern: For instance, Trump has said he will disband the White House Office of Pandemic Preparedness and Response Policy. In light of ongoing outbreaks like mpox and the spread of H5N1 influenza in American dairy cows, now is not the time to deprioritize pandemic preparedness initiatives.
However, while there are real downside policy risks, a second Trump administration might also offer opportunities. After all, one of the biggest accomplishments of the first Trump administration was Operation Warp Speed, a public-private partnership that developed COVID-19 vaccines in record time.
Indeed, the America First Agenda — the America First Policy Institute’s blueprint for a Trump-Vance administration — has the explicit goals of protecting the health of the most vulnerable, modernizing regulatory frameworks, and leveraging public-private partnerships in advancing American infrastructure.
Drawing from declared priorities of Republican lawmakers and center-right policy experts, we can extrapolate what the Trump-Vance administration could do on biosecurity. Below, we highlight five key steps that align with the core tenets of the Republican agenda. This analysis should not be read as a prediction, but rather as an exploration of what might be accomplished in a second Trump administration.
Conduct common-sense biorisk management
Congressional Republicans have expressed interest in creating common-sense biorisk management. The Trump-Vance administration is well-positioned to take the overdue step of creating a centralized federal registration system that would allow for comprehensive yet confidential oversight and enforcement of biosafety practices, procedures, and training.
Given the long history of near-miss lab accidents, improving lab biosafety is a no-brainer. Currently, only facilities with the highest level of containment (BSL-4) and laboratories working with biological select agents and toxins are required to register with the Federal Select Agent Program (FSAP). While countries like Canada and the UK maintain comprehensive registration systems for biolabs, America’s patchwork approach leaves dangerous blind spots. Recent incidents, like the discovery of an illegal biolab in California, underscore the urgent need for reform.
Another area of increased biosecurity concern and oversight was the National Institutes of Health’s (NIH) relationships with the EcoHealth Alliance and the Wuhan Institute of Virology. The Biden administration, prodded by work of the National Science Advisory Board for Biosecurity, has moved to improve government oversight of research with pathogens with enhanced pandemic potential. The Trump administration could take these efforts further, building on early-stage ideas floated by GOP lawmakers on how to continue improving biosafety and biosecurity and structurally reform the NIH.
Streamline regulatory approval
During the pandemic, Food and Drug Administration (FDA) employees pulled long hours to review COVID-19 treatments and diagnostics as quickly as possible — a laudatory achievement. However, there were still some stumbles that deserve scrutiny. For example, the FDA’s initial approach to regulating COVID-19 lab-developed tests (LDTs) through Emergency Use Authorization (EUA) significantly harmed early testing efforts. It wasn’t until February 29, 2020, that the agency allowed certain laboratories to use validated LDTs before completing their EUA requests, causing a critical delay that restricted testing capacity when the U.S. needed it the most.
More recently, the FDA has moved to assert regulatory authority over LDTs, traditionally overseen by the Centers for Medicare & Medicaid Services (CMS). Hospital and public health labs have warned that overly rigorous review processes harm the availability of tests in public health crises, echoing the challenges of the FDA’s brief regulation of LDTs during the COVID-19 pandemic. Moreover, the recent Supreme Court decision to overturn the Chevron doctrine has created regulatory uncertainty by limiting federal agencies’ interpretive authority, jeopardizing the FDA’s efforts to regulate LDTs. The ranking Republican on the Senate HELP committee, Sen. Cassidy (R-LO), has publicly rebuked the FDA for its recent LDT rule-making, and called for congressional action to clarify the situation. Congress, CMS, and FDA could collaborate to establish unambiguous statutory authority for LDT oversight to ensure access to rapidly available diagnostic tools in public health crises.
Later in the pandemic, most testing capacity came from at-home test kits. These tests are particularly vital for Americans in underserved and rural areas and provide individuals with crucial health information from the privacy of their homes. However, subjecting these tests to the same stringent EUA standards as clinical diagnostics hindered their timely approval and deployment. A reformed approach could evaluate at-home tests based on their broader public health benefits, considering different factors like accessibility, speed of results, and accuracy. To do so, the FDA could develop new internal guidance that balances traditional accuracy requirements with practical public health considerations. Alternatively, Congress could direct the FDA to create a separate authorization track specifically designed for public health tools.
Prioritize an agile Strategic National Stockpile model
As the COVID-19 pandemic unfolded, the U.S. lacked ready-made countermeasures and faced critical shortages of health supplies. While the U.S. maintains the Strategic National Stockpile (SNS) precisely to prepare for such emergencies, its effectiveness is severely limited if we prepare for the wrong pathogen — as evidenced by our focus on influenza that left us ill-equipped for a novel coronavirus.
Echoing conservative calls for SNS reform, the federal government could move toward a more flexible SNS model, including reconfigurable kits for medical countermeasures that could be adapted to novel or emerging pathogens within days. However, flexibility alone will be insufficient. The early pandemic reliance on Chinese-made personal protective equipment underscores the dangers of outsourcing critical health supplies. A revitalized SNS could be backed by sufficient federal funding and long-lasting public-private partnerships, ensuring the domestic manufacturing base stays warm. This dovetails nicely with the America First Agenda’s goal of building resilient supply chains that rely on domestic workers and our allies. The work of the congressionally mandated (bipartisan) National Security Commission on Emerging Biotechnology (NSCEB) is a signal that this is a bipartisan interest.
Modernize the CDC
During the COVID-19 pandemic, the Centers for Disease Control and Prevention (CDC) struggled to fulfill its role as America’s public health fire department on several fronts. The CDC’s flawed testing strategy, inconsistent crisis communication, and struggle to provide real-time COVID-19 data all contributed to the U.S.’s poor performance.
Modernizing an agency like the CDC is not straightforward, but would pay dividends in strengthening public health and preparing for future pandemics. For instance, the CDC could prioritize electronic data collection and improve interagency data-sharing as part of the reform of its Public Health Data Strategy. During the pandemic, the CDC and local agencies relied on fax machines and paper records. Strategically modernizing the CDC could generate long-term savings for taxpayers by eliminating redundancies and streamlining public health response.
Separately, nonpartisan experts have proposed a return to the CDC’s founding mission as a communicable disease agency, arguing that its expansion into non-communicable diseases has weakened its core functions. While the CDC does not necessarily need to abandon its work on non-communicable diseases, it could refocus on its operational readiness as the country’s primary public health response agency. Specifically, Congress could encourage joint exercises between the CDC, the Federal Emergency Management Agency (FEMA), and the Administration for Strategic Preparedness and Response (ASPR) to clarify responsibilities during public health emergencies.
Leverage public-private partnerships for biosurveillance
The ongoing H5N1 influenza outbreak in American cattle went undetected for months, allowing the virus to spread across the U.S. While many federal biosurveillance programs exist, they often lack interoperability and integration. In addition, these programs often specifically detect a single pathogen, which means they are unable to pick up novel threats like H5N1 influenza. Instead, the Trump administration could prioritize pathogen-agnostic systems that can pick up any pathogen.
The UK, for instance, recently created the “world’s first early warning system” for pandemics. In partnership with the private company Oxford Nanopore, certain hospitals now routinely sequence samples from patients with severe respiratory infections. The U.S. has similarly successful public-private partnerships, like Ginkgo Biosecurity’s work on the CDC’s Traveler-based Genomic Surveillance program and Verily’s work on the National Wastewater Surveillance System. These partnerships could be sustained and potentially expanded to cover more pathogens or even be completely pathogen-agnostic.
Conclusion
Potential pandemic threats like H5N1 influenza not only affect human health, but also threaten American security and economic competitiveness. It is unclear how the Trump administration will handle current and future outbreaks. We aim to outline a constructive path forward that aligns with the Republican policy agenda, acknowledging that biological threats don’t pause for political transitions.
