Center for Health Security responds to US Senate RFI with recommendations for Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization

April 3, 2023 – The Johns Hopkins Center for Health Security continues to be a trusted, independent, and expert voice in policy conversations about the Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization, which is due this fall. On March 29, the Center provided feedback and recommendations in response to a Request for Information (RFI) released earlier this month by Senate Health, Education, Labor, and Pensions Committee Chair Sen. Bernie Sanders (I-VT), Ranking Member Sen. Bill Cassidy (R-LA), and Sens. Robert P. Casey, Jr. (D-PA) and Mitt Romney (R-UT). This submission follows the Center’s response to a US House RFI issued by Rep. Richard Hudson (R-NC) and Rep. Anna Eshoo (D-CA) on the same topic.

PAHPA is a groundbreaking piece of legislation that was first signed into law in 2006. It is widely considered a “must pass” bill that bolsters the nation’s medical and public health preparedness and response capabilities against deliberate, accidental, and natural biological threats, as well as other crises. Previous iterations authorized the Administration for Strategic Preparedness and Response (ASPR) and the Biomedical Advanced Research and Development Authority (BARDA), among other advancements.

The Center for Health Security’s recommendations consist of 5 categories of policy recommendations: (1) establishing a ‘Disease X’ Medical Countermeasures Program at BARDA; (2) supporting innovative next-generation reusable respirators for the Strategic National Stockpile (SNS); (3) requiring mandatory screening of gene synthesis orders and customers; (4) implementing a National Diagnostics Action Plan; and (5) improving US bioattribution capabilities.

1. ‘Disease X’ Medical Countermeasures (MCM) Program: Congress should require BARDA to establish a ‘Disease X’ MCM program to protect against unknown viral threats.
2. Next-generation reusable respirators: Congress should require ASPR to create target product profiles (TPPs) for next-generation reusable respirators and a process of recurring competitive bidding for products meeting increasingly stringent TPPs.
3. Gene synthesis screening: Congress should require the Department of Health and Human Services (HHS) to prescribe a regulation requiring gene synthesis providers and manufacturers to screen all customers and incoming orders of gene sequences and to require all purchasers of gene sequences to order only from providers and manufacturers who perform such screening.
4. National Diagnostics Action Plan: Congress should implement a National Diagnostics Action Plan (preprint here).
5. Bioattribution: Congress should task the Office of Science and Technology Policy (OSTP) with coordinating federal bioattribution efforts across and outside of government, as well as with establishing a working group to maximize existing databases and data resources for bioattribution purposes. Congress should also authorize funding for the improvement of current, or the development of new, bioattribution technologies.

In taking these actions, Congress can ensure that critical gaps in national pandemic prevention and preparedness are filled and that our health, economic, and national security are hardened.

Read the Center's full Senate RFI response.

Read the Center’s full House RFI response.

Please note: A Capitol Hill Steering Committee on Pandemic Preparedness & Health Security in-person panel and reception, titled “The Future of Pandemic Preparedness: Why PAHPA Reauthorization is the Keystone,” was held on March 30 in Washington, DC. A recording of the event will be available here.