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What Should Be Included In PAHPA's Reauthorization?

Former governors, senators and medical experts weigh in

Executive Summary

At the first meeting of the Capitol Hill steering committee on pandemic preparedness, experts weighed in on what they hope to see in PAHPA’s reauthorization.

Members of the Capitol Hill steering committee on pandemic preparedness, organized by Johns Hopkins University urged Congress to reauthorize the Pandemic and All Hazards Preparedness Act (PAHPA)—with the right improvements.

PAHPA was first signed into law in 2006 in the wake of Hurricane Katrina. Since then, it has been reauthorized in 2013 and 2019 and is back up for reauthorization this year. (Also see "US Legislators Weaving Cybersecurity, National Stockpile Care Into Pandemics Bill" - Medtech Insight, 12 Jun, 2018.)

The steering committee presentation included a keynote by the ranking member of the Senate Committee on Health, Education, Labor and Pensions Bill Cassidy, R-LA, who was on the ground in Louisiana during Hurricane Katrina. He stressed the importance of the legislation to the congressional staffers in the audience.

Assistant Secretary for Preparedness and Response at the Department of Health and Human Services Dawn O’Connell, former Kansas Governor and HHS Secretary Kathleen Sebelius and Director of JHU’s Center for Health Security Tom Inglseby all weighed in on their recommendations for necessary updates to the legislation, all stemming from lessons learned from the COVID-19 pandemic.

“The worst thing that can happen is we go back to 2019 and we look the same as we did back then,” O’Connell said.

Let HHS Do What It Needs To Do

O’Connell explained her experience working with other governmental organizations such as the Department of Defense (DoD) and the Federal Emergency Management Agency (FEMA), who were able to mobilize resources in support of HHS. The DoD assisted HHS in acquiring contracts and FEMA helped surge staff “in way that HHS was not able to.”

Through PAHPA, O’Connell wants to secure authorities for HHS that would allow it to work independently from other organizations so that it can “the [the DoD] and FEMA do what [they] need to do” in the face of a complex disaster.

That will require a hard look at the assistance that outside organizations provided to HHS, and O’Connell said she’s already having these conversations with Congress.

“[These] are the things I'm thinking about—how we take the transformation that's happened in these last three years… and make sure that it's consistent with the authorities we have in PAHPA for now and moving forward,” she said.

Preparation For Disease X

The country needs to be prepared for events that are “substantially worse than COVID,” Inglseby said when asked what he hopes to see in the reauthorization. He noted that experts are preparing for a novel pandemic, which has been given the name “Disease X” as a placeholder.

This preparation will require a “robust, well-funded, authorized effort in [the Biomedical Advanced Research and Development Authority], and elsewhere in the government… to do this Disease X work,” he said.

BARDA received a nearly $1bn boost in funding to prepare for future pandemics as a part of the omnibus spending bill passed at the end of 2022. (Also see "Omnibus Funding Bill Provides Provisions For Future Pandemic Preparedness" - Medtech Insight, 17 Jan, 2023.)

When such a situation occurs, reusable medical supplies will be the key to ensuring healthcare workers have the personal protective equipment (PPE) they need to do their jobs, panelists said.

“We can never be in a position again where we have doctors and nurses using… plastic bottles to cover their faces to try to provide themselves protection,” Inglesby said.

The government needs to change its thinking about PPE and consider adding reusable products that won’t be “immediately depleted by people reaching for the same supply chain around the world,” he said.

Medical device reprocessing expert Dan Vukelich echoed similar statements in an interview with Medtech Insight in November 2022. (Also see "FDA Should Undo Incentives For Single-Use Products, Device Reprocessing Expert Says" - HBW Insight, 18 Nov, 2022.)

“COVID revealed that our global supply chain for disposable healthcare products is fragile,” he said. “And so reprocessing or greater device reuse in general is in the long run is less costly, less wasteful, less demanding on the supply chain and creates less emissions.”

Finally, Inglesby stressed the importance of diagnostics in fighting Disease X.

During the beginning of the COVID-19 pandemic, the country didn’t have diagnostics for a longer period than was acceptable, he said.

“That is not because of a science failure—the companies were ready to move forward, but we had a problem in the interaction between government and the private sector, which can be fixed and should be fixed,” Inglesby said.

Reform is as simple as a “series of concrete things… we can do around coding, around contracting, and making sure we have contracting authorities that will change the game on diagnostics entirely,” he explained.

Members of Congress recently reintroduced the VALID Act in the House, which would reform the FDA’s oversight of diagnostic tests. (Also see "Diagnostics Reform Reintroduced in House" - Medtech Insight, 31 Mar, 2023.)

Appeal From Governors

Sebelius, who served as governor of Kansas from 2003 through 2009, said that failure to reauthorize PAHPA would send a terrible message to the country and the rest of the world.

She further noted that governors had been on the front lines of the pandemic. Usually, disasters work locally and move up from there—a local government provides the first response, then can ask the state and national governments for help. The COVID-19 pandemic worked the opposite way, and the federal government took the lead.

States found themselves competing for help during the government during the COVID-19. In other disasters, states are often able to borrow resources from neighboring states, Sebelius explained, but in the case of COVID-19—where the disaster was hitting everywhere at once—only the federal government had the bandwidth to provide that support.

“I remember our governor saying very honestly, when asked by the press, [that] she couldn't possibly compete with California to get supplies to Kansas. I mean, we didn't have the bandwidth; she didn't have the budget, she didn't have the authority,” Sebelius said, referring to Kansas Gov. Laura Kelly.

From left to right: Moderator Jennifer Alton, Dawn O’Connell, Tom Inglesby

Governors and National Governors Association’s (NGA) Public Health and Disaster Response Task Force co-chairs Ned Lamont (CT) and Phil Scott (VT) also sent a letter to Senate HELP committee members providing feedback on the reauthorization as well. Chiefly, they echoed the panelist’s sentiments that coordination between the CDC, ASPR and HHS is critical, as well as clear definitions of the roles of FEMA and HHS during PHEs.

PAHPA answers the big question of “who’s in charge?” Sebelius explained, and a clear chain of command is essential to effective disaster relief efforts.

Lamont and Scott also urged the creation of strategic state stockpiles because state and local needs can differ from the federal needs. They wrote that they recommend “extending the authorization for grants to support state strategic stockpiles beyond FY24 as part of PAHPA reauthorization.”

Governors need to be able to utilize the National Guard more efficiently, and they recommend that the National Guard provide more members with specific health care training.

The FDA’s emergency use authorizations were effective, but states felt that the educational material was “too dense for some audiences,” and recommended the agency put up quick fact sheets and one-pagers as additional documentation.

Federal disaster response should be a coordinated effort with governors, Sebelius said.

“You have people across this country who have actually been on the frontlines of a pandemic response, who have watched what worked and didn't work,” she said. “Call governors the [moment] you have the opportunity.”

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