ASM Responds to Senate HELP Draft of PAHPA Reauthorization
|The Honorable Bernard Sanders
Chair, Committee on Health, Education, Labor and Pensions
U.S. Senate, Washington, D.C. 20510
|The Honorable Bill Cassidy
Ranking Member, Committee on Health, Education, Labor and Pensions
U.S. Senate, Washington, D.C. 20510
|The Honorable Bob Casey
Member, Committee on Health, Education, Labor and Pensions
U.S. Senate, Washington, D.C. 20515
|The Honorable Mitt Romney
Member, Committee on Health, Education, Labor and Pensions
U.S. Senate, Washington, D.C. 20515
The American Society for Microbiology (ASM) appreciates the opportunity to provide comments in response to the discussion draft of the 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA). The United States must be prepared to rapidly respond to declared and potential public health emergencies, including infectious disease pandemics such as COVID-19. We have learned a great deal over the past three years, and PAHPA reauthorization is an important opportunity to improve our nation’s ability to respond in a timely and coordinated manner to future declared and potential public health threats.
Thank you again for this opportunity to provide feedback. Our comments below follow in the order of the legislation and track the sections of the bill where there are areas of particular importance to ASM and our members.
TITLE I—STATE AND LOCAL READINESS AND RESPONSE
Sec. 105. Enhancing domestic wastewater surveillance for pathogen detection.
ASM strongly supports this section, which authorizes the Centers for Disease Control and Prevention (CDC) to award grants or cooperative agreements to establish, maintain, or improve activities related to the detection and monitoring of infectious diseases through wastewater for public health emergency preparedness and response purposes. We also support the inclusion of language supporting research on the use of wastewater surveillance to detect and monitor emerging infectious diseases. Wastewater surveillance, while commonly used to monitor pathogen and chemical levels in communities through municipal sewer systems, gained national attention during the COVID-19 pandemic as a useful metric for measuring viral presence and prevalence, and the establishment of the National Wastewater Surveillance System (NWSS) at the CDC helped inform local responses to COVID-19. This language helps secure the NWSS’ future, which has been uncertain as the current network was established in 2020 and is funded in large part through emergency supplemental funding. We encourage you to include a specific authorization level of $130 million per year in the bill for this program.
TITLE II—FEDERAL PLANNING AND COORDINATION
Sec. 201. All-Hazards Emergency Preparedness and Response.
ASM supports the work of the Assistant Secretary for Preparedness and Response (ASPR) and believes the new organizational structure that elevates the office to an Administration is the appropriate direction, given our experience with COVID-19 and the need to strengthen our ability to respond quickly and effectively. ASM is pleased to see the requirement for a report by ASPR on a coordinated strategy form medical countermeasures to address chemical, biological, radiological, and nuclear threats.
We support the creation of the Supply Chain Control Tower and FDA’s Resilient Supply Chain and Shortages Prevention Program, as administered by and partnered with ASPR. When the demand for testing increased in the spring of 2020, clinical microbiology laboratories were unable to fully deploy testing due to unpredictable shortages. A lack of testing supplies coupled with anxiety over the potential to exhaust existing supplies hindered our ability to bring the pandemic under control. Beyond reagents, there were shortages of transport media, swabs, and plastics, affecting tests developed and offered by independent, hospital and academic-based laboratories. ASPR should consider, as part of these programs, initiating a national inventory of diagnostic equipment, including research laboratories and those with smaller machines, and developing a national database, accessible by all laboratories, to identify available equipment and ensure all resources are utilized.
These programs need sustained funding, and ASM recommends increasing their authorization through PAHPA. The program also could be strengthened with additional authorities, including ensuring that the statutory authorities relating to device shortages are equal to those available when there are drug shortages. In particular, the time limitation and tie to public health emergencies (PHE) for manufacturers to submit device shortage notifications puts the FDA behind in responding to early signs of supply constraints or a potential shortage.
Sec. 202. Strategic National Stockpile and material threats.
The Strategic National Stockpile is critical to readiness in a public health emergency. The inclusion of diagnostics and ancillary supplies is as important as other medical countermeasures and we urge the Committee to ensure that diagnostic tests and ancillary supplies (swabs, pipette tips and reagents to name a few) are considered “qualified pandemic or epidemic products.”
Clinical testing supply shortages plagued laboratories over the course of the pandemic, with a tremendous impact on our ability to test for COVID-19, and therefore diagnose those with the infection to administer countermeasures such as therapeutics. The diversion of resources to meet that demand also prevented necessary testing for “routine” infectious diseases such as sexually transmitted infections, strep throat, and urinary tract infections. The nature of these shortages even negatively affected diagnostics for non-infectious diseases like cancer, which require some of the same supplies. Diagnostics enable and inform all aspects of infectious disease outbreak management—from surveillance and detection, to response, containment and recovery. As such, we must ensure that diagnostic supplies and ancillary provisions receive the same attention in our preparedness efforts as medical countermeasures.
Sec. 203. Medical countermeasures for viral threats with pandemic potential.
ASM is pleased to see the inclusion of some of the language from the Disease X Act of 2023, sponsored by Sen. Tammy Baldwin and Sen. Thom Tillis, which would allow the United States to prepare for the future and work to rapidly develop the necessary medical countermeasures to combat future pandemics.
While we are pleased with the inclusion of the language, we are concerned that the amendment to subparagraph (F) is situated within clause (ii) because that clause governs threats that consistently exist or continually circulate and have a significant potential to become a pandemic. “Disease X” by nature is an unknown virus with pandemic potential, not something that is consistently existing or continually circulating. We recognize and appreciate that the Committee attempted to preserve advanced research and development elements of Disease X that were cut out of (D) by including it into clause (ii), but as drafted it would not help to guard against unknown pathogens with pandemic potential. Accordingly, we recommend the following additions.
1. Give medical countermeasures for pathogens with pandemic potential its own clause (that includes advanced R&D), or
2. Amend the lead-in language in clause (ii) to say "threats that
a. (I) consistently exist or continually circulate and have a significant potential to become a pandemic, such as pandemic influenza; or
(II) include priority virus families and other viral pathogens with a significant potential to cause a pandemic; and
(III) which may include the advanced research and development, manufacturing, and appropriate stockpiling of qualified pandemic or epidemic products, and products, technologies, or processes to support the advanced research and development of such countermeasures (including multiuse platform technologies for diagnostics, vaccines, and therapeutics; virus seeds; clinical trial lots; novel virus strains; and antigen and adjuvant material)."
Finally, ASM strongly recommends that there is dedicated funding for this program that does not impact other medical countermeasure funding.
TITLE IV—STRENGTHENING BIOSECURITY
Sec. 403. Evaluation of the Federal Select Agent Program and related policies.
ASM supports the inclusion of this provision that would seek to harmonize select agent, dual use and enhanced potential pandemic pathogen research policies under a common framework and charge the National Science Advisory Board for Biosecurity with making additional recommendations within a specific time period. However, we encourage you to modify the following language (in bold) to be more inclusive of stakeholders who should be consulted for input:
(A) be developed in consultation with stakeholders and experts representing institutions of higher education, academic medical centers, scientific societies, industry, and other government agencies;
Sec. 404. Supporting research and laboratory surge capacity.
ASM strongly supports the inclusion of this language to strengthen the role and authorize funding for the regional biocontainment laboratory network. We encourage you to consider adding language that authorizes robust and sustained funding for the national biocontainment laboratories, which are also critically important to our response infrastructure and have not been funded at a sustainable level in recent years. The NBLs work in tandem with the RBLs and both are equally important to our research response capacity.
Lastly, we urge the Committee to consider additional language that would support clinical laboratory surge capacity in addition to research laboratory surge capacity. Qualified academic, hospital-based and independent laboratories should play an essential role in the early stages of a pandemic in both diagnostic testing and genomic surveillance; yet during the early days of the COVID-19 response, we relied solely on public health labs and the Centers for Disease Control and Prevention (CDC)—a decision that cost us critical time in our testing response. Laboratories (both public and private) are a critical component of any public health response and need to work together to ensure accurate, reliable and safe testing can be deployed as quickly as possible in an emergency. We recommend including language in the PAHPA reauthorization that was included in the 117th Congress’ H.R. 4128, Sec 3, and which exempts laboratory-developed tests from pre-market approval when a public health emergency (PHE) is underway, with follow up requirements that are important to ensure that high complexity lab testing close to the patient is not stymied.
To ensure better partnerships between academic and other clinical laboratories in emergencies and provide a trained, “surge” workforce for the short-term, ASM calls for a “national guard” structure, or a rapid response force of clinical microbiologists and other laboratory professionals who could help reinforce the health care system in the event of a major crisis or pandemic. ASM suggests the following language, which follows existing language around the “Earlier Development of Diagnostic Tests” that was included in the PREVENT Pandemics bill that passed as part of the FY 2023 omnibus legislation (new language in bold).
(b) EARLIER DEVELOPMENT OF DIAGNOSTIC TESTS.—Title III of the Public Health Service Act is amended by inserting after section 319A (42 U.S.C. 247d–1) the following:
‘‘SEC. 319B. EARLIER DEVELOPMENT OF DIAGNOSTIC TESTS. …
The Secretary may contract with qualified academic, hospital-based, and independent clinical laboratories to build private sector laboratory testing capacity in, during, or outside of a national public health emergency including support for:
1. Hiring and training qualified laboratory personnel that could be deployed as part of a surge laboratory workforce as appropriate;
2. The purchase and maintenance of laboratory equipment, including testing platforms, reagents, and other testing supplies;
3. Maintaining a ready reserve of clinical laboratory capacity outside of public health emergencies;
4. Training exercises during non-emergency settings to ensure emergency readiness and coordination with state public health laboratories.
We thank you for your leadership and appreciate your consideration of our comments on the draft legislation to reauthorize PAHPA. ASM and its members stand ready to assist you in this effort. If you have any questions, please contact Mary Lee Watts, ASM Director of Federal Affairs at firstname.lastname@example.org.
ASM Chief Advocacy Officer
Read ASM's response to the Senate HELP Committee's request for information on reauthorization of the Pandemic All-Hazards and Preparedness Act (PAHPA).