Letter to Alex Azar, Department of Health and Human Services Secretary - Enzi Says Emergency Health Stockpile Needs to Be Reliable

Letter

Date: June 9, 2020

Dear Secretary Azar:

I write to inquire about the plan that the Administration recently announced to modernize the
Strategic National Stockpile (SNS). The SNS plays an integral part in bolstering supplies for state, local, tribal, and territorial partners during public health emergencies, including the coronavirus pandemic. The ongoing pandemic has put unprecedented pressure on the SNS to meet nationwide demand for critical supplies, such as personal protective equipment, and persistent shortages have unfortunately highlighted gaps in pandemic preparedness. White House officials have noted that at the time the pandemic hit American shores, the SNS stocked only "28 percent of needed items [for coronavirus response] and …less than a month's supply of key items." Our experience over the last few months has shown that SNS inventories are not sufficient to meet the surge in demand for supplies needed by frontline providers, which is troubling given the possibility of a second wave of coronavirus infections this fall that could coincide with flu season and an "above-normal" hurricane season. It is critical to ensure the SNS is able to meet nationwide demand for key supplies should these three factors converge in the fall and place even
more strain on our health care system than it is currently experiencing.

Though Congress enacted the SNS -- then known as the National Pharmaceutical Stockpile -- to
meet health needs stemming from a chemical, biological, radiological, or nuclear (CBRN) attack in the United States, Congress has expanded its scope to an all-hazards approach given that the country faces serious public health threats beyond CBRN threats, including emerging and infectious diseases, and natural disasters like hurricanes and wildfires. Given this broad mission and critical role in national security, experts have long stressed the importance of careful strategic planning to ensure that SNS supplies can be rapidly deployed as needed to support response in any type of public health emergency. Press reports indicate that the Administration plans to expand the SNS to create a 90-day reserve of medical supplies like masks, gowns, ventilators, and "crucial drugs" to combat the coronavirus or other pandemics. Administration officials have said the plan would be to stock "a much broader and deeper set of supplies" than kept in the SNS. I appreciate the Administration's efforts to improve our nation's pandemic preparedness and ensure that stocked inventories are consistent with the responsibilities that the
SNS has been asked to meet.

HHS has historically played a key leadership role in managing the SNS to respond to the public
health emergencies by pushing critical supplies to those on the frontlines and working with manufacturers to ramp up production capabilities of depleted inventories and other critical medical countermeasures. As the Administration releases plans to modernize the SNS, it is important that any changes are carefully considered so that Americans can have continued confidence in the stockpile's capacity to respond during a public health emergency, whether a CBRN threat or infectious disease. I respectfully ask that HHS provide written answers to the following questions by August 6, 2020:

1. Can the SNS be expanded and/or restructured with existing funds? What level of resources does
HHS require, on an annual basis, to support the modernized SNS? How will HHS increase focus
on pandemic preparedness while continuing to ensure that the existing SNS maintains readiness
to respond to a CBRN threat?
2. What necessary products were missing from the existing SNS when HHS declared a public health
emergency for COVID-19? What medical supplies, testing supplies, and "crucial drugs," does
HHS intend to procure for the modernized stockpile? Do these products have a viable commercial
market?
3. How is HHS engaging with experts to determine what is needed and to recommend new medical
countermeasure priorities for the modernized SNS? Will HHS coordinate with the Public Health
Emergency Medical Countermeasures Enterprise (PHEMCE)? How will HHS adapt the annual
threat-based review of SNS contents, performed in consultation with the PHEMCE, to a
modernized SNS?
4. Are press reports accurate that HHS intends to ensure that supplies in the modernized SNS are
manufactured by U.S. companies? If so, how will this be implemented? How will HHS
coordinate with manufacturers to ensure supplies are ready to be deployed if the expected 90-day
supply runs out during a future public health threat?
5. How will HHS balance short-term needs like replenishing the SNS in advance of a potential
second wave of coronavirus infections with long-term goals like ensuring preparedness for future
pandemics or other unanticipated public health threats?
6. What steps can HHS take to ensure that the procurement process is nimble enough to rapidly
respond to new research and changes in clinical practices as our understanding of emerging or
infectious diseases evolve?

Thank you for your consideration of this request. If you have any questions, please have your
staff reach out to Amanda Lincoln at (202) 224-3424.


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