The broad outlines of an upcoming debate over a pandemic preparedness reauthorization bill are beginning to emerge as regulators, policymakers and industry groups take stock of lessons learned from COVID-19.
The latest reauthorization of the 2006 pandemic preparedness law, which created a sweeping set of emergency medical programs, expires in September, and is the only major must-pass health bill Congress is considering this year.
Because of that, the bill could serve as the vehicle for both a bevy of industry riders and a number of partisan disputes that exploded during the pandemic.
Lawmakers have begun collecting public input on what programs should be added or amended. Bipartisan groups of lawmakers on the House Energy and Commerce and the Senate Health, Education, Labor and Pensions committees solicited public feedback in recent weeks, while federal officials and health advocates have made pitches in public remarks.
Rep. Brett Guthrie, R-Ky., who chairs the Energy and Commerce Subcommittee on Health, said the panel will likely hold hearings in late spring.
“I think what we need to figure out is not looking back just to look back and point fingers,” he said. “But look back and say, alright, where did we fail?”
Ranking member Anna G. Eshoo, D-Calif, shares a similar view.
“I think, in an overarching way, that we demonstrate the capacity to acknowledge the mistakes that we’ve made, what we learned in the pandemic,” she said, “and speak to that in the legislation.”
But political rifts are certain to resurface. Partisan disputes over federal spending will likely affect negotiations, especially now that the emergency phase of the pandemic is over.
“We’re going to have to be a little bit wiser in terms of how we use those resources to go forward,” Senate HELP Committee ranking member Bill Cassidy, R-La., said during an event hosted by the Capitol Hill Steering Committee on Pandemic Preparedness and Health Security last week.
The bill could also become a vehicle for fights over risky “gain-of-function” research — the definition of which experts disagree on, but which typically strengthens pathogens — as well as over the origins of the virus.
“I do think this is an appropriate place for us to consider gain-of-function research and whether that should be something which is funded or not funded,” Sen. Mitt Romney, R-Utah, said.
Rep. Earl L. “Buddy” Carter, R-Ga., last week introduced a bill with Rep. Henry Cuellar, D-Texas, to temporarily ban the National Institutes of Health from funding such research.
Both Guthrie and Energy and Commerce Chair Cathy McMorris Rodgers, R-Wash., have also criticized the NIH and the Centers for Disease Control and Prevention for the pandemic response.
“Like NIH, the CDC does not need more authority,” Rodgers said during an appropriations hearing with Health and Human Services Secretary Xavier Becerra last week. “It needs robust oversight.”
Better data and clarity of federal roles
CDC Director Rochelle Walensky has asked Congress for expanded data authorities as requirements for labs and hospitals wind down after the public health emergency ends in May.
Walensky last year endorsed a bill led by Rep. Lauren Underwood, D-Ill., and Sen. Tim Kaine, D-Va., to allow CDC to require broad “public health and health care data” from providers, labs, states, localities and others. But the bill had no Republican sponsors and was ultimately shelved in favor of more narrow data-sharing provisions included in the fiscal 2023 government spending bill.
Organizations like the Johns Hopkins Center for Health Security, IT advocacy group Health Innovation Alliance and health consultancy Premier Inc. are calling for a national interoperable, real-time data collection and exchange system authorized under the original pandemic law in 2006.
Johns Hopkins also teamed with the American Clinical Laboratory Association on a “national diagnostics plan” that calls for, in part, a permanent public-private working group to facilitate partnerships in emergencies.
Industry groups are also calling for additional clarity on responsibilities and authorities afforded to federal agencies with overlapping missions.
The CDC, the Administration for Strategic Preparedness and Response and the Food and Drug Administration all launched reorganizations in recent months, while the 2023 spending bill created a new White House Office of Pandemic Preparedness and Response Policy.
Ellie Dehoney, senior vice president of policy and advocacy at Research!America, also pointed to NIH, the Biomedical Advanced Research and Development Authority and the new Advanced Research Projects Agency for Health.
“Just generally, to make sure that there’s not competition — there’s collaboration,” she said, “and that that collaboration stays in separate lines of funding.”
ASPR authorities
In July, the Biden administration elevated the Administration for Strategic Preparedness and Response, or ASPR, to an operating division within HHS, giving the agency more administrative freedom.
Assistant Secretary Dawn O’Connell now seeks additional authorities to help ASPR respond in the next emergency. That includes contracting authorities that the Department of Defense facilitated for Operation Warp Speed and surge staffing capacity for situations that aren’t large enough to trigger help from the Federal Emergency Management Agency.
“Can HHS have those authorities?” she said during the pandemic steering committee event. “And in this world of complex disasters, can we let FEMA do what FEMA needs to do and let HHS do what HHS needs to do?”
Improving access to critical supplies
President Joe Biden’s budget request includes $20 billion across ASPR, NIH, CDC and FDA for research on medical interventions that could thwart a future pandemic. The goal is to advance key technologies that could be adapted quickly, like mRNA was for the COVID-19 vaccines. ASPR would receive $10 billion under the request, with an additional $400 million slated for a speedy ramp-up when the next pandemic hits.
Advocacy groups and regulators are also urging Congress to further strengthen the Strategic National Stockpile and critical supply chains. ASPR last week released a multi-year budget assessing five-year funding gaps in emergency programs like the stockpile.
“We all saw what happened in March 2020 when we opened it up and we didn’t find what we needed,” O’Connell said at an Axios event last month, “because the whole world needed the exact same thing at the exact same time, and much of it was being manufactured in other places.”
Diagnostic test oversight
The reauthorization will also likely function as another battleground for a bill to strengthen oversight of diagnostic tests developed and performed in laboratories, which was scuttled last year amid House procedural concerns and industry pushback on impacts to academic medical centers.
The bill was reintroduced last week by Reps. Larry Bucshon, R-Ind., and Diana DeGette, D-Colo.
“What’s going to happen is, if we don’t do this legislatively, FDA is going to do something, right?” Bucshon said. “And my preference always is to have a legislative process.”
FDA is indeed planning to move forward alone, though it lacks the power to enforce the bill’s comprehensive overhaul. The pandemic shoved the regulatory issues into the limelight as faulty tests flooded the market, and internal disputes among Trump administration officials sowed confusion about the FDA’s authority.
“We think it’s vitally important for spurring innovation and doing responsible innovation,” FDA Center for Devices and Radiological Health Director Jeffrey Shuren said in a recent interview with the Alliance for a Stronger FDA. “New doesn’t matter if it really doesn’t work, or doesn’t work well.”
Medical device group AdvaMed has lobbied for the increased oversight, which its diagnostics members already undergo. But the lab industry has signaled it could challenge the FDA in court.
Other industry asks
Lobby groups have a lengthy wish list of additional riders that could end up in the mix.
The American Hospital Association wants to at least double funding for a hospital preparedness program. The Association of Public Health Laboratories is hoping to expand the CDC’s radiochemistry capacity through state labs and increase construction authority to rehab and build new public facilities.
Lab groups also hope to ward off another round of contentious Medicare cuts through a bipartisan, bicameral bill led by Rep. Richard Hudson, R-N.C., who is also leading the pandemic reauthorization work with Eshoo in the House.
That bill is likely better suited for an end-of-year extender package for expiring Medicare programs, but at least some diagnostics groups like AdvaMed are already making the case for the pandemic legislation, telling Congress that “robust” infrastructure is essential during non-emergent times and to prepare for future pandemics.”
Ariel Cohen contributed to this report.
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