On June 9, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN) released a 40-page white paper, Preparing for the Next Pandemic. Chairman Alexander is seeking stakeholder input to inform legislation that he hopes to see enacted by the end of this year. In an effort to translate the lessons learned from the COVID-19 public health emergency into better preparedness for the next pandemic, Chairman Alexander is seeking responses to recommendations posed and questions raised in five key issue areas.

Questions from the five key issue areas include the following:

Tests, Treatments and Vaccines

• What incentives can the federal government offer to the private sector to encourage development of more medical countermeasures with no commercial market?
• Should the federal government create government-owned-contractor-operated facilities to solve supply chain and manufacturing challenges?
• How can the federal, state and private sector work together to more effectively distribute and administer treatments and vaccines?
• How can the United States build manufacturing systems that can rapidly respond to new threats?
• What is the appropriate federal role in supporting the manufacturing of medical countermeasures, especially vaccines?
• How can Congress and HHS make sure CDC and FDA are working more closely with the private sector on diagnostic tests to detect emerging diseases?
• How can the United States better leverage public-private partnerships, industry and academic institutions?
• Are additional or more predictable liability protections needed to incentivize manufacturers of medical products that are not approved or cleared by the FDA for use during a certain emergency to scale up manufacturing capacity?

Disease Surveillance

• What appropriate role can innovative technologies play to improve public health surveillance?
• What privacy protections should accompany new technology? Would these technologies be utilized and maintained by HIPAA covered entities or others?

Stockpiles, Distribution and Surges

• How can the Strategic National Stockpile be better managed and how can Congress increase oversight and accountability?
• How can states and hospitals improve their ability to maintain a reserve of supplies in the future to ensure the Strategic National Stockpile is the backup and not the first source of supplies during emergencies?
• What steps should be taken to ensure that health care providers and first responders have the supplies they need, such as personal protective equipment?
• As states and hospitals establish or build their own stockpiles, how will they know what supplies to stockpile? What guidance should the federal government provide on what medical supplies are appropriate?
• Could states and hospital systems establish their own vendor managed inventory programs with manufacturers and distributors? Should the federal government or states contribute to such hospital stockpiles?

Public Health Capabilities

• What specific changes to our public health infrastructure (hospitals, health departments, laboratories, etc.) are needed at the federal, state and local levels?
• What changes can be made to Public Health Emergency Preparedness and Hospital Preparedness Program to help states prepare and respond more quickly?
• How can the federal government ensure all states are adequately prepared without infringing on states’ rights and recognizing states have primary responsibility for response?
• How should the federal government ensure agencies like CDC maintain an appropriate mission focus on infectious diseases in the periods between emergencies to strengthen readiness to respond when a new threat arises?

Improve Coordination of Federal Agencies During a Public Health Emergency

• Is the Assistant Secretary for Preparedness and Response the right position to coordinate a whole-of-government response to a pandemic?
• What is the appropriate role for HHS and how can the Federal Emergency Management Agency (FEMA) be better integrated into a nationwide pandemic response?
• Whose job is it to coordinate supply lines so that personal protective equipment, ancillary supplies and medicines are available and delivered to where they are needed when they are needed?
• What is the right balance between specific and limited statutory authority and more flexibility for federal preparedness and response programs?
• Have well-intended requirements and directives created too much bureaucracy and slowed federal response?
• How can federal departments and agencies more effectively work together to respond to public health emergencies?

On June 23, 2020, the Senate HELP Committee will hold a hearing entitled “COVID-19: Lessons Learned to Prepare for the Next Pandemic.”

The white paper can be found here. Comments are due by 5 PM ET on June 26, 2020 and should be submitted to PANDEMICPREPAREDNESS@HELP.SENATE.GOV.