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- Introduction
- 1. Expand BARDA’s mandate to include threat-agnostic approaches (Disease X)
- 2. Modify the Project BioShield mandate to include threat-agnostic approaches (Disease X)
- 3. Move toward a “reconfigurable” Strategic National Stockpile model
- 4. Establish a PHEMCE external advisory committee to increase transparency
- 5. Clarify roles and responsibilities between ASPR and FEMA
- 6. Increase the level of intelligence provided to ASPR and the PHEMCE
- 7. Expand ASPR contracting authorities
- 8. Require the CDC to create a national policy on field biosafety
- 9. Require ASPR to provide oversight of gene synthesis providers and customers
IFP submitted a letter with the following recommendations to the Senate HELP Committee on March 29, 2023.
Introduction
Over the past few years it has become increasingly clear that strong and agile preparedness and response capabilities for biological threats are crucial for the safety and security of our nation. In response to this pressing need, the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) presents a timely opportunity to reassess and fortify our national biosecurity apparatus. The evolving nature of biological threats, which now encompass not only known pathogens but also unknown, accidental, engineered, and natural hazards, necessitates a comprehensive and flexible approach to preparedness and response.
To address these challenges, we have identified nine core recommendations aimed at enhancing the United States’ ability to prevent, detect, and respond to biological threats. These recommendations focus on broadening the scope of key agencies and initiatives, such as the Biomedical Advanced Research and Development Authority (BARDA) and the Strategic National Stockpile (SNS), as well as increasing transparency in the decision-making processes of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). In the face of an ever-changing biothreat landscape, these recommendations seek to ensure that the United States remains at the forefront of pandemic preparedness and innovation.
1. Expand BARDA’s mandate to include threat-agnostic approaches (Disease X)
Context
- Today, the Biomedical Advanced Research and Development Authority’s mandate limits its responses to specific chemical, biological, radiological, and nuclear threats. This approach was designed in 2006 when the biological threat landscape consisted of mostly known pathogens (e.g., Anthrax). Unfortunately, this mandate is no longer sufficient in a world where BARDA must respond to a rapidly evolving biological threat landscape that includes known, unknown, accidental, engineered, and natural biological threats.
- It is crucial to broaden BARDA’s mandate to allow the agency to work on broad-spectrum or pathogen-agnostic prevention techniques. These approaches are both practical and cost effective. Furthermore, broadening BARDA’s mandate is aligned with Objective 1.1. of the BARDA Strategic Plan 2022-2026, which emphasizes the need to “accelerate the development of agile MCMs that can pivot and be brought to scale in response to new threats.”
- These changes to BARDA will result in the development of agile and resilient medical countermeasures and prevention capabilities that can respond to current and future biological incidents.
Recommendation
- Congress should modify BARDA’s mandate to give it the responsibility to provide basic response and prevention tools for all accidental, engineered, and natural biological incidents. This modification corresponds to the ASPR Strategic Plan 2022-2026 Objective 1.2, which calls for addressing an evolving threat landscape where novel and engineered threats require investments in broad-spectrum and pathogen-agnostic approaches.
- Congress should add threat-agnostic measures to the (F) Strategic initiatives clause of the current statute. This approach could be modeled on S.2640 Disease X Act, which calls for the establishment of a pan-viral family medical countermeasure program within the U.S. Department of Health and Human Services.
- BARDA should lead the development of next-generation medical countermeasures such as ultraviolet-C (UVC) systems for preventing disease transmission and metagenomic diagnostic systems with integrated reporting for the detection of novel pathogens. These tools should be deployed before a disease outbreak to enable early detection and mitigate potentially serious consequences. See suggested bill text in Appendix A.
2. Modify the Project BioShield mandate to include threat-agnostic approaches (Disease X)
Context
- Project BioShield funding is based on a list of material threats determined by the U.S. Department of Homeland Security’s Material Threat Assessment. HHS conducts its own assessment to determine which countermeasures should be prioritized based on the DHS material threats list.
- The focus on individual material threats was a response to the biothreat landscape of 2006, which mostly consisted of known pathogens. Unfortunately, this narrow focus prevents Project BioShield from using its funds to respond to a modern biothreat landscape that includes combinations of known, unknown, and/or engineered biological threats.
- Given changes in the threat landscape, Congress should allow HHS to increase investment in threat-agnostic approaches. This would provide the flexibility to target multiple material threats with one capability, and address material threats in the context of more broadly applicable countermeasures and capabilities.
Recommendation
- In order for the HHS to use Project BioShield funding to develop multi-threat capabilities or countermeasures, Congress should modify Clause (B) Determination of Material Threats in BARDA’s mandate. See suggested bill text in Appendix B.
3. Move toward a “reconfigurable” Strategic National Stockpile model
Context
- Reconfigurable and rapidly deployable platform-based technologies would complement existing SNS products and countermeasures for known biological threats (e.g., smallpox or anthrax) by increasing the SNS’s responsiveness to unknown biological threats with Disease X products.
- Reconfigurable platform-based technologies can be used to create targeted diagnostic tests, vaccines, and therapeutics. A reconfigurable SNS model will require stockpiling limiting components that can be used to respond to a variety of critical biothreats.
- For instance, once a particular threat is identified, platform-based technologies like mRNA can be reconfigured to produce a range of more potent and targeted medical countermeasures, such as incorporating specific mRNA sequences for different protein targets. In addition, flexible and rapid advanced manufacturing can quickly make new products available on a wide scale.
- A “reconfigurable” SNS model would be more agile and would keep industry partners primed for developing medical countermeasures and capabilities during non-public health emergencies.
- Rapid tests using innovative CRISPR-based platform-based technologies are multipurpose. They can be stockpiled for threat response but can also be commercialized for a variety of endemic diseases such as sexually transmitted infections.
- Stockpiling otherwise limiting components for mRNA-based vaccine platforms enables the rapid deployment of targeted vaccines in a public health emergency. The SNS already stockpiles components for vaccine administration. Including upstream components would complement this approach.
- A “reconfigurable” SNS and the resulting commercial market is aligned with the warm-base manufacturing provisions in the 2023 Consolidated Appropriations Act. It would foster regional bioindustrial manufacturing hubs and drive biotechnology investment to under-resourced areas of the country.
Recommendation
- Modify the definition of products in the SNS to explicitly include platform-based technologies. See suggested bill text in Appendix C.
- Congress should require the U.S. Food and Drug Administration to create a path for platform-based in-vitro diagnostics in the SNS. This would be similar to the path that was recently created for platform-based therapeutics. Further information is available in Appendix D.
- Congress should authorize the FDA to conduct a risk-benefit analysis during the Emergency Use Authorization review process, taking into account the full range of an EUA’s potential benefits and harms to individual and public health. This would capture many of the unique strengths of at-home rapid diagnostics that are not currently reflected in FDA’s standard decisionmaking (e.g., immediate results, low cost, and potential over-the-counter uses) and reduce the burden on healthcare systems during emergencies.
- Past action includes the FDA Risk Analysis to assess the safety and effectiveness of the rapid HIV test OraQuick in 2012 to support its approval for over-the-counter use. This was the first and only rapid test to receive such an approval prior to the COVID-19 pandemic.
- Congress should authorize the FDA to conduct a risk-benefit analysis during the Emergency Use Authorization review process, taking into account the full range of an EUA’s potential benefits and harms to individual and public health. This would capture many of the unique strengths of at-home rapid diagnostics that are not currently reflected in FDA’s standard decisionmaking (e.g., immediate results, low cost, and potential over-the-counter uses) and reduce the burden on healthcare systems during emergencies.
- Congress should designate BARDA, in coordination with FDA, as the USG lead for independent test validation. Further information is available in Appendix E.
- The SNS should include reconfigurable platforms for rapid diagnostic tests, vaccines, and therapeutics to address a range of known and unknown pathogens. In non-public health emergencies, these platforms can be cycled through other public health settings to address endemic diseases.
4. Establish a PHEMCE external advisory committee to increase transparency
Context
- The 2019 PAHPAIA reauthorization formalized PHEMCE roles and responsibilities, but ambiguities persist in decision-making processes.
- In 2021, both the U.S. Government Accountability Office and National Academies of Science, Engineering and Medicine provided recommendations on restructuring the PHEMCE to clarify SNS decision-making processes.
- The GAO report recommended ASPR restructure the PHEMCE to increase transparency SNS annual reviews and other decision-making processes. The report emphasizes the need to foster greater interagency collaboration while also making sure proper safeguards protect sensitive information.
- The NASEM report outlined key problems with PHEMCE decision-making, including ambiguous processes for reviewing, assessing, and procuring SNS products. Additionally, PHEMCE practices were described as not fully scientific, justifiable, transparent, adaptive, or accountable.
- A PHEMCE external advisory committee would also ensure consistency during political transitions, which has impeded PHEMCE effectiveness.
Recommendation
- To address transparency problems with PHEMCE decision-making, Congress should authorize an external advisory committee to advise the Secretary of HHS, the Assistant Secretary for Preparedness and Response (ASPR), and the heads of all Federal entities that conduct, support, or have an interest in the medical countermeasure enterprise.
- This committee would be made up of no more than 20 public and private experts, such as former ASPR and SNS staff, industry representatives, hospital preparedness administrators, end-users, and other SLTT stakeholders. Meetings of the PHEMCE external advisory committee and any subcommittees would be conducted according to the Federal Advisory Committee Act and other Department policies.
- Meetings of the full committee should be held approximately three times within a fiscal year. They may be convened on an as-needed basis as determined by the executive director of the PHEMCE external advisory committee or a designated federal officer. The PHEMCE external advisory committee should also have an annual public meeting.
- The PHEMCE external advisory committee should:
- Recommend strategies and guidance for enhancing transparency and accountability around the medical countermeasure enterprise.
- Advise the records management of the SNS annual review and other PHEMCE activities.
- Review PHEMCE decision-making practices for reviewing, assessing, and procuring SNS products, and recommend practices for securing sensitive documentation.
- Review PHEMCE priority-setting processes and recommend public communication strategies of priorities for enterprise partners.
- Recommend multifunctional countermeasure investments and opportunities to leverage private sector and academic innovation to address unmet prevention and medical countermeasure needs.
- Advise on the creation of a data system to monitor the entire medical countermeasure pipeline (i.e., research, development, and deployment),
- Address any other issues as directed by the Secretary of HHS.
5. Clarify roles and responsibilities between ASPR and FEMA
Context
- This reauthorization should reaffirm the role of the ASPR as the “principal advisor to the Secretary on all matters related to Federal public health and medical preparedness and response for public health emergencies,” especially as ASPR expands its operational capabilities. In particular, this reauthorization should ensure that ASPR is the primary driver of the public health emergency response and is empowered to coordinate effectively with FEMA to provide response resources as detailed in the Stafford Act.
Recommendation
- Congress should encourage ASPR and FEMA to conduct joint exercises to ensure clear operational roles and responsibilities during disease outbreaks as well as public health emergencies. Exercises should adhere to the National Response Framework and the National Incident Management System and should incorporate federal, SLTT, and private sector stakeholders.
- Congress should hold a joint briefing or hearing every five years to ensure ASPR is coordinating effectively with FEMA. This hearing should emphasize that responsibilities during public health emergencies are clearly articulated and executed.
6. Increase the level of intelligence provided to ASPR and the PHEMCE
Context
- To adequately prepare for emerging chemical, biological, radiological and nuclear threats, ASPR must have sufficient personnel to receive relevant national security threat intelligence and ensure appropriate readiness and response.
- There should be a cadre of PHEMCE members that can be briefed on relevant national security threat intelligence to ensure SNS readiness and effective response to the CBRN threat landscape.
Recommendation
- Increase the number of ASPR personnel with appropriate security clearances.
- Increase the number of PHEMCE members with appropriate security clearances.
7. Expand ASPR contracting authorities
Context
- Increasing the contracting authority for ASPR to flexibly procure and acquire products would allow the administration to competitively partner with industry.
Recommendation
- As an operating division, ASPR’s contracting authority must be increased in order to meet its mission.
- ASPR should have similar authority as the U.S. Department of Defense’s general procurement and acquisition authority, outlined by 10 U.S.C. § 4023. See suggested bill text in Appendix F.
- ASPR should also have innovative general procurement and acquisition authority similar to DoD’s authority outlined in 10 U.S.C § 3458. See suggested bill text in Appendix G.
- ASPR should also have authorities, similar to those outlined in the Defense Production Act Title III (50 USC 4531-4534), to enable industrial base expansion and domestic industrial support. In addition to scaling production, these capabilities would allow ASPR to commercialize key R&D investments to prevent and respond to CBRN threats.
8. Require the CDC to create a national policy on field biosafety
Context
- The Office of the Director of National Intelligence flagged the lack of field biosafety standards as cause for concern given increased field sampling and advanced research in its 2023 Annual Threat Assessment.
- For example, improper bat field research for biomedical sampling could result in viral spillover.
- Field biosafety is typically overseen at the institutional level. Federally, there are also no field biosafety standards across different departments and agencies. This results in fractured oversight and a lack of comprehensive federal standardization of field biosafety.
Recommendation
- Congress should require the CDC to add a chapter on field biosafety to the Biosafety in Microbiological and Biomedical Laboratories (BMBL) manual to provide guidance to field researchers.
9. Require ASPR to provide oversight of gene synthesis providers and customers
Context
- Many synthetic DNA providers have implemented voluntary screening systems to mitigate risk. These systems verify customers’ identities and monitor orders to ensure harmful sequences are not released to inappropriate parties. Unfortunately, screening is inconsistent across the industry due to lack of federal oversight.
- As the cost of DNA synthesis falls, screening will make up a greater share of the total cost of synthesis. This will make it harder for companies that screen to remain competitive with those who don’t.
- The U.S. has long been a biotechnology leader and it should demonstrate its leadership by creating norms that will allow the domestic bioeconomy to safely grow.
- A 2018 NASEM report highlights biodefense concerns around synthetic pathogen misuse. The report emphasized that synthetic biology increases the range and harmfulness of pathogens that can be produced, decreases the timeframe of engineering pathogens, and broadens the types of actors that manipulate pathogens.
- ASPR should coordinate with the Office of the Director of National Intelligence as well as the Department of Commerce to create a robust regulatory framework on gene synthesis.
Recommendation
- We recommend including a gene synthesis screening bill in PAHPA reauthorization.