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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 393 Russell Senate Office Building U.S. Senate, Washington, D.C. 20515	The Honorable Mitt Romney 354 Russell Senate Office Building U.S. Senate, Washington, D.C. 20515

Dear Chairman Sanders, Ranking Member Cassidy, Senator Casey and Senator Romney:

������ý (ASM) thanks you for your leadership of the Pandemic and All-Hazards Preparedness Act (PAHPA), and we appreciate the opportunity to share our views as you consider bipartisan reauthorization of this important legislation. The ������ý 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.

Below are responses to several items outlined in your request for information. 

Program Effectiveness
Public Health Emergency Coordination and Policy: Programs Under the Assistant Secretary for Preparedness and Response (ASPR)

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. 

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. 

These new programs need sustained funding, which could be authorized 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.  

Medical Countermeasures Development and Deployment: Strategic National Stockpile and the Biomedical Advanced Research and Development Authority

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 Congress 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.

ASM supports the inclusion of the Disease X Act, which was originally introduced by Sen. Tammy Baldwin as S. 2640 in the 117th Congress, and would allow the ������ý States to prepare for the future and work to rapidly develop the necessary medical countermeasures to combat future pandemics. Currently there is no sustained funding, program or strategy dedicated to accelerating the development of medical countermeasures for previously unidentified infectious disease threats. The Disease X Act would provide $2 billion to BARDA over 4 years to help better prepare against unknown threats. Instead of funding a specific virus that may or may not present a future threat, the Disease X Act would focus medical countermeasure development efforts on the viral families most likely to cause pandemics and coordinate federal agencies to fund disease preparedness efforts.

A new, dedicated Disease X Medical Countermeasure Program would leverage technologies and vaccine platforms most suitable to the viral families that are likely to cause future catastrophic disease outbreaks. Medical countermeasures against one member of a viral family could easily be adapted to another member quickly when the next threat emerges. With this flexible approach, private–public partnerships could develop vaccines, antivirals and tests for a range of unknown potential pandemic pathogens in months, not years.  

Gaps in Current Activities and Capabilities and Partnerships
CDC Programs Are Essential to Readiness

As CDC implements its “Moving Forward” plan, we encourage greater recognition of the essential role many programs under its purview play in readiness. Specifically, we want to highlight the Advanced Molecular Detection (AMD) program within the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), which brings cutting edge, next generation sequencing of pathogens to the front lines of public health. This innovative program, established in 2014, was significantly underfunded and undervalued until the COVID-19 pandemic shone a spotlight on the enormous need for rapid, accurate detection and genomic characterization of the novel pathogen, especially as variants emerged and evolved. Had this program been more fully supported at a level closer to $175 million per year, the “surge” required during the pandemic would have been easier to deploy. 

Beyond the technology it brings to public health laboratories in all 50 states and the District of Columbia, the AMD program funds bioinformatics training programs and has established important partnerships with academic institutions, most notably in the newly established Pathogen Genomics Centers of Excellence. The program also partnered with private sector and commercial entities to accomplish the task of sequencing during COVID, setting an example for how these connections can be sustained  to address seasonal, foodborne and epidemic threats to the U.S., including antimicrobial resistance. We strongly encourage the Committee to ensure that the AMD program and others that are essential to readiness are authorized at the necessary funding levels and are more fully integrated into response policies and plans as you reauthorize PAHPA.

Clinical Laboratories Play an Essential Role in a Public Health Emergency

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, we call for a “national guard” structure, or a rapid response force of microbiologists and other scientists who could help reinforce the health care system in the event of a major crisis or pandemic.¹ This would allow hospital laboratories to serve as the backbone for medical diagnoses in a pandemic.
 
Other Points for Consideration
ASM Supports the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB)

ASM supports the mission of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) to provide advice, information and recommendations to the Secretary of Health and Human Services regarding programs and policies intended to support and evaluate the implementation of U.S. government activities related to combating antibiotic-resistant bacteria. PACCARB membership consists of scientific experts that review and evaluate the role antimicrobials play in cross-cutting areas including but not limited to: climate change and its impact on anti-microbial resistance, human health and Antibiotic Stewardship Interventions to prevent and reduce infection and improve health outcomes, and pandemic preparedness and response efforts—all of which inform the PACCARB whole-of-government National Action Plan on Combating Antibiotic-Resistant Bacteria. ASM strongly supports this Plan and concurs with the recommendation that it should continue to be updated every 5 years to ensure the most relevant data is being used to inform lawmakers and guide policy decisions.

ASM Supports a Comprehensive Review of the COVID-19 Response 

ASM supports the establishment of a Task Force or 9/11-like Commission with membership appointed by bipartisan Congressional and Committee leadership to examine the initial emergence of SARS-CoV-2 and to examine and assess the ������ý States’ preparedness for and response to the COVID-19 pandemic. This review should include the initial and ongoing Federal, state and local responses to COVID-19 including related health disparities, identifying gaps and making recommendations to the President and Congress.

We thank you for your leadership and appreciate your consideration of our recommendations for the reauthorization of 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 mwatts@asmusa.org. 

Sincerely,
 
Stacey L. Schultz-Cherry, Ph.D.
Chair, ASM Public and Scientific Affairs Committee


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