Before the lessons of COVID-19 fade into yesterday’s news, Congress should start preparing for the next pandemic, Sen. Lamar Alexander (R-Tenn.) is advising.

As the chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, the senator issued a white paper Tuesday identifying areas that must be addressed – accelerating R&D for tests, treatments and vaccines; improving infectious disease surveillance; rebuilding stockpiles and improving the medical supply surge capacity and distribution; improving local and state public health capabilities; and improving coordination of federal agencies during a health emergency.

“Even with an event as significant as COVID-19, memories fade and attention moves quickly to the next crisis,” Alexander said in rolling out the paper. “That makes it imperative that Congress act on needed changes this year in order to better prepare for the next pandemic.”

In a foreword to the white paper, William Frist, a doctor and former Senate majority leader, added to the urgency of acting now to prepare for later, warning that “like all previous pandemics, COVID-19 too will shift from center stage. The public will have had their fill. The danger will seem removed.”

The question now is whether Congress, which tends to be driven by the crisis of the moment, especially in an election season, will heed the warning as it continues to deal with the urgency of responding to the current pandemic.

Congress’ track record isn’t that great. Following a disaster or public health emergency in the past, Congress took stock, passed some legislation, perhaps provided a temporary bump in funding and then moved on to its next priority. Meanwhile, Alexander said, various administrations, inspectors general, the Government Accountability Office (GAO) and outside experts continued to warn lawmakers of serious gaps in the nation’s preparedness.

Lessons unlearned

Following the H1N1 scare 11 years ago, for example, the GAO found that additional action was necessary “to address capacity needs to respond to and recover from an influenza pandemic, such as identifying additional treatment space, and acquiring and distributing medical countermeasures, such as antivirals and vaccines, and other necessary supplies,” according to Alexander’s white paper, which is intended to guide the HELP Committee in drafting legislation to ensure the U.S. is better prepared the next time around.

The 2009 GAO report highlighted the challenges of preparing for a medical surge in a mass casualty event like a pandemic vs. a regional disaster. It cited a National Governors Association report that “states would likely be unwilling to share scarce resources.”

Alexander’s white paper also referenced a Health and Human Services (HHS) review of the response to H1N1 that identified significant problems with testing. HHS reported the frustration of health care providers because diagnostics for accurately detecting influenza, especially for confirming H1N1, weren’t readily available. And the low sensitivity of commercially available rapid antigen-detection tests resulted in misdiagnosis and under-treatment of people with H1N1.

The government’s 2018 response to Zika again revealed continuing gaps in the nation’s testing capability, according to the white paper. Last year, the GAO reported that the 16 tests the FDA authorized for Zika during the outbreak “varied in their ability to detect the virus and provide accurate results.” Additionally, test manufacturers had difficulty accessing clinical samples, and health care providers faced challenges in determining the most accurate test to use and in getting the equipment required to run the tests.

HHS was recently reminded of the unanswered challenges and preparedness gaps when it conducted its Crimson Contagion Functional Exercise Series, which culminated with a full-scale national exercise in August 2019, just a few months before SARS-CoV-2 jumped to humans in China.

The scenario for the Crimson Contagion simulation was eerily similar to COVID-19 – a highly transmissible strain of H7N9 avian influenza spilled over into humans and was first detected in people around the world who had recently been to China with a tour group. The outbreak then developed into a mock global pandemic.

The exercise revealed serious shortcomings that became reality during COVID-19, including the fact that the global supply chain for necessary medical supplies would be inadequate to meet the demand of a global pandemic, according to the white paper. It also showed that HHS lacked the mechanisms to direct other government departments and agencies during a nationwide response without the support of FEMA and would not be able to finance such a response without supplemental appropriations from Congress.

However, the training exercise missed significant issues that arose in the real-world pandemic, such as an increased demand for sedative drugs to intubate patients, the white paper pointed out.

Noting the failures of the past, Alexander, who is retiring from the Senate after this year, said Congress, even in the midst of responding to COVID-19, “should take stock now of what parts of the local, state and federal response worked, what could work better and how, and be prepared to pass legislation this year to better prepare for the next pandemic, which will surely come.”

Pandemic food for thought

In his white paper, “Preparing for the next pandemic,” Sen. Lamar Alexander (R-Tenn.) offers several recommendations and raises a number of questions for Congress to consider as it looks to make the U.S. better prepared for the future.

While many of the recommendations deal with improving infectious disease surveillance and government coordination, a number of them would directly impact the drug and device industries:

  • identify and implement public-private manufacturing models to improve and maintain sustainable domestic vaccine manufacturing capacity and capabilities;
  • continue to support NIH research and its academic partnerships;
  • implement the Medical Countermeasure (MCM) Innovation Partner program so tests, treatments and vaccines can be quickly identified, researched and developed for the next pandemic;
  • engage and partner with the private sector early on to develop diagnostic tests, ensure flexibility to develop and use laboratory-developed tests in a public health emergency, and ensure that the national stockpile is better prepared to address diagnostic needs;
  • use existing authorities to build public-private partnerships to create excess medical supplies managed by private-sector partners that might be needed in a pandemic or public health emergency;
  • require appropriate levels of personal protective equipment and ancillary medical supplies to be stockpiled and replenished, both at the federal and state level;
  • establish plans in advance for how the federal government, states and the private sector will coordinate to assess needs and distribute newly developed tests, treatments or vaccines;
  • ensure state and health system stockpiles are developed and maintained, with some federal support; replenish and expand the federal Strategic National Stockpile to include supplies needed to respond to a pandemic; maintain the stockpile with more oversight and accountability;
  • ensure the U.S. doesn’t lose the gains made in telehealth during COVID-19.

Recognizing there may be other steps Congress should take to help federal, state and local officials be better prepared for the next pandemic, Alexander is seeking comments on several questions, including 10 dealing with accelerating the R&D and manufacturing of tests, therapies and vaccines:

  • What incentives can the government offer to the private sector to encourage development of more MCMs with no commercial market?
  • Should the federal government create government-owned, contractor-operated facilities to solve supply chain and manufacturing challenges?
  • What could the government have done to be better positioned with diagnostics, vaccines and treatments for COVID-19?
  • How can the federal, state and private sector work together to more effectively distribute and administer treatments and vaccines?
  • How can the U.S. build manufacturing systems that can rapidly respond to new threats?
  • What is the appropriate federal role in supporting the manufacturing of MCMs, especially vaccines?
  • How can Congress and HHS make sure the CDC and the FDA work more closely with the private sector on diagnostic tests to detect emerging diseases?
  • How can the U.S. better leverage public-private partnerships, industry and academic institutions?
  • What lessons have been learned from the current fast-tracking of tests, treatments and vaccines that can make them available even more rapidly?
  • Are additional or more predictable liability protections needed to incentivize manufacturers to scale up manufacturing capacity for emergency use of MCMs that have yet to be approved or cleared?

– by Mari Serebrov

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