Washington, DC Update

Posted 14 May 2020

COVID-19 continues to dominate the legislative agenda in Congress as states attempt to navigate how to lift stay-at-home orders. On April 24, Congress passed and President Trump signed into law the Paycheck Protection Program and Health Care Enhancement Act (PPPHCEA), sometimes referred to as “CARES 3.5” or as the fourth COVID-19 relief package. The bill focused mainly on its namesake PPP, but it did include billions for COVID-19 testing and research. Since passing that bill, however, Congress has ground to a halt in considering what to do next. Republican leadership has slow-walked development of a new package, while also declaring any new package must include liability protections for businesses that reopen. Democrats have rejected a liability shield outright. Meanwhile, Democrats have proposed their own legislation, the Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, which includes additional billions for health research, incorporates the text of the Global Health Security Act, and addresses some of the roadblocks to U.S. participation in CEPI. 
 
NIH Abruptly Terminates EcoHealth Alliance Grant

It appears that The Trump Administration’s campaign to blame China for shortcomings in the global response to the pandemic led to the cancelation of a highly-rated NIAID grant to the EcoHealth Alliance. The grant included a partnership with the Wuhan Institute of Virology on the transmission of coronaviruses from bats to humans. Read the  ASTMH statement on the need to protect the integrity of the peer-review process.  ASTMH joined with IDSA, the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society of America (PIDS) in a letter to President Trump urging immediate reconsideration and assurances that politics will not influence the scientific process. 
 
President Trump Continues to Target WHO  
 
After placing a 60-day hold on U.S. funding for WHO, President Trump and his Administration have continued to criticize the organization as being deferential to China and have urged allies to join in such efforts. A group of 17 House Republicans called on WHO Director-General Tedros Adhanom to resign.  A group of Senate Democrats is pushing back on the Administration’s WHO decision and has proposed legislation to support WHO and U.S. funding of WHO. ASTMH has issued a statement on WHO funding and is working with Congressional allies.

NIAID, CDC, HHS, FDA Leaders Testify at Senate COVID-19 Hearing 

On Tuesday, May 12, the Senate Health, Education, Pensions and Labor Committee held a hearing, "COVID-19: Safely Getting Back to Work and Back to School." The witnesses, all testifying remotely due to COVID-19 infection concerns included Anthony Fauci, MD, Director, NIAID; Robert Redfield, MD, Director, CDC; ADM Brett Giroir, MD, Assistant Secretary For Health, HHS; and Stephen Hahn, MD, Commissioner, FDA. The hearing was chaired by Sen. Alexander (R-TN) remotely while a few Senators attended from the U.S. Senate building and others from their homes. The witnesses, while even-keeled, presented a picture of what is needed and how far we must go to "get back to normal."   
 
Rick Bright Ouster at BARDA Subject of Whistleblower Complaint, Congressional Hearing
 
Rick Bright, PhD, the former director of the Biomedical Advanced Research and Development Authority (BARDA), has alleged in a whistleblower complaint that he was transferred to NIH as an act of retaliation for criticizing the Trump Administration’s response to the pandemic, including President Trump’s promotion of hydroxychloroquine. Dr. Bright testified before the House Energy and Commerce Committee’s Health Subcommittee on the matter May 14. Dr. Bright, however, was also the subject of complaints in 2019 prior to the pandemic.

COVID-19 Technology and Vaccine Development
 
The FDA issued an Emergency Use Authorization for remedesivir, Gilead’s broad-spectrum antiviral, while NIH has launched the Rapid Acceleration of Diagnostics (RADx) initiative, a $1.5 billion effort to develop new COVID-19 technologies in concert with FDA, CDC and BARDA. Meanwhile, the WHO launched the Access to COVID-19 Tools Accelerator (ACT Accelerator). The Accelerator brings together 11 global health agencies and pharmaceutical organizations, including the Global Fund and GAVI, to ensure equitable global access to innovative COVID-19 tools.
 
CARES 3.5 Health Appropriations
 
CARES 3.5 provided an additional $321 billion in Paycheck Protection Program funding, $75 billion for hospitals, and $25 billion for COVID-19 research and testing, the latter of which includes:
  • $11 billion for states, localities and tribes for COVID-19 testing, tracing and analysis
  • $1.8 billion for NIH to accelerate the development of improved COVID-19 tests, including rapid tests
  • $1.0 billion for CDC for surveillance, data modernization and laboratory expansion
  • $1.0 billion for BARDA to develop and manufacture diagnostic and serologic supplies
USAID was not included in this package.

Will There be a Next Relief Package? 

Republicans and Democrats have drifted far apart on a new relief package. House Democrats have laid down their ideas in the HEROES Act, but Republicans have labelled that legislation dead on arrival and stuffed with non-COVID-19 items. Among the global health items in the HEROES Act:
  • Inclusion of the Global Health Security Act
  • Inclusion of the Wildlife-Borne Disease Prevention Act
  • Inclusion of the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act and similar pharmaceutical and medical device supply chain language
  • Inclusion of the Securing America from Epidemics Act, which would authorize U.S. participation in CEPI
  • $4.745 billion for NIH COVID-19 research
  • $4.575 billion for BARDA, including
    • $3.5 billion for therapeutics and vaccines
    • $500 million for “next-generation” manufacturing facilities in the U.S.
    • $500 million for antibacterial research and development
    • $75 million for the BARDA inspector general
A compromise deal, if one happens, may retain some of these provisions.

Cures 2.0 Blueprint Released

Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) released a concept paper for a follow-up to their 21st Century Cures Act, which became law in 2016. Cures 2.0 will focus on pandemic public health preparedness, caregiver integration, patient engagement, clinical trial diversity, digital health regulations at the FDA, and Medicare and Medicaid coverage of new technology. The two sponsors hope the legislation, or parts of it, can become law this year rather than waiting for FDA User Fee reauthorization in 2022.
 
FY 2021 Appropriations Status Update

There is tentative agreement among members of both parties that Fiscal Year 2021 appropriations will include increased health spending and that such an increase will require shifting funds to off-budget accounts to avoid budget caps. Senate Appropriations Committee Vice Chair Patrick Leahy (D-VT) has proposed using emergency authorities at the Department of Veterans Affairs to shift veterans funding off-budget to free up $11 billion, while Tom Cole (R-OK), the ranking member on the House Appropriations Committee’s health subcommittee, along with Rep. Rose DeLauro, chair of the subcommittee, have backed the concept of a Health Defense Fund that would take critical funding for CDC, NIH and other public health entities off-budget to allow for the substantial increases needed to have a prepared public health infrastructure.