Senate HELP Hearing 2020-06-30 CDC FDA NIAID HHSASH

Source: US Senate Committee on Health, Education, Labor and Pensions

Send in your ideas to help the Senate question Drs. Fauci, Redfield, Hahn, and Giroir about the US response to COVID-19

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The COVID-19 novel coronavirus pandemic is devastating the United States – over 2.4 million infections, 125,00 deaths, and high unemployment and other severe economic impacts.

On Tuesday, June 30th, the Senate Committee on Health, Education, Labor, and Pensions is holding a hearing to question the leaders of the National Institute of Allergy and Infectious Diseases, Centers for Disease Control and Prevention, Food and Drug Administration, and Office of the Assistant Secretary For Health about the federal response to COVID-19.

The Committee wants to hear your thoughts on diagnostic testing capabilities, hospital capacity, national policy for infection control, contact tracing, vaccine development, treatments, personal protective equipment, or the medical supply chain, among other issues.

This website gives you an opportunity to tell Congress what issues should be discussed during this critical hearing. You can submit questions that lawmakers should ask witnesses (sample questions below), personal stories about your experiences related to COVID-19 or other infectious diseases, or your general thoughts on how Congress can help Americans through the COVID-19 crisis.

Hearing details

US response to the COVID-19 pandemic

What: Senate Committee on Health, Education, Labor, and Pensions hearing

Who: The witnesses who will testify during this hearing are:

  • Anthony Fauci, MD – Director, National Institute Of Allergy And Infectious Diseases, National Institutes of Health
  • Robert Redfield, MD – Director, Centers for Disease Control and Prevention
  • Stephen Hahn, MD – Commissioner Of Food And Drugs, Food and Drug Administration
  • Admiral Brett Giroir, MD – Assistant Secretary For Health, Department of Health and Human Services

When: Tuesday, June 30, 2020 at 10:00am ET

Where: G50 Dirksen Senate Office Building, Washington, DC / Webcast

Nonpartisan analysis and research

Sample questions for lawmakers to ask witnesses. Please share yours for lawmakers.

More sample questions will be added as objective contributions are received from the expert community. Kindly submit your idea via the form below. Last updated Monday 6/29/2020.

The epicenter of the US COVID-19 outbreak has shifted to the South, Southwest, and West. Hospitalization rates have increased in 16 states. Tragically, many Americans continue to die from the coronavirus.

Your agencies gained experience working with previous COVID-19 hotspots like New York City and New Jersey. Using lessons learned from that experience, what improvements have your agencies made in coordinating with state and local governments to help manage the current phase of the response to the pandemic?

With flu season on the horizon, the COVID-19 pandemic and seasonal flu may converge. Little is known about the interaction of SARS-CoV-2 and the influenza virus in people, and simultaneous COVID-19 and flu surges could overwhelm hospitals.

What should be done to prepare for this possibility, and what is the plan? How is the federal government coordinating the interagency, as well as working with state and local governments? What might the toll of such a convergence be on Americans if the US is not prepared?

The Administration’s Strategic National Stockpile was found lacking in the face of COVID-19. N95 masks, for example, were very limited, and US frontline healthcare workers had to make do with unsatisfactory personal protective equipment. More than 400 US health care workers have died from COVID-19.

A group of nine former presidential science advisors warned that the US needs to build the stockpile back up by September 1st in order to be prepared for a possible COVID-19 resurgence in the fall, and that state and local supply inventories need to be stocked as well. That was before the coronavirus recently surged in the US South, Southwest, and West, which is certainly requiring a high level of medical supplies.

Is the health care system currently getting what it needs in terms of medical supplies – N95 masks, other personal protective equipment, ventilators, medicines? What is the current status of the stockpile? How many N95 masks are available for distribution? What about other personal protective equipment, like face shields, gowns, and gloves? How many operational ventilators are available for distribution?

Early in the pandemic, US public health officials did not recommend that the public wear masks. It turns out that wearing masks can help reduce COVID-19 transmission, and now, Americans should wear masks in public.

If all Americans wore masks in public, kept our distance from one another, and maintained good hygiene (washing our hands and not touching our faces), that would be a major step toward mitigating this deadly disease. This isn’t new; this guidance has been on the CDC’s website.

What is being done about communicating with the American public about participating in the fight against COVID-19? Are there plans for a public health campaign with a high level of reach?

While some regions of the US, such as New York City and New Jersey, have seen declines in rates of COVID-19 cases, other regions, such as the South and Southwest, are surging.

How is the US Government helping hospital systems currently seeing surges of COVID-19 patients, and helping others maintain readiness for surges of COVID-19 patients? Please explain the US Government leadership and coordination structure in this effort.

Science and fact and reason are the best tools to fight a pandemic. Has the emergency funding provided to the US public health apparatus been sufficient? Please explain why or why not.

What should schools and daycare centers be doing now to be ready to safely reopen in the fall? What have we learned from COVID-19 about the role of schools and daycares in both disease transmission and, and about how much families rely on schools and daycares?

Follow-up: What resources – financial, public health, etc. – are available to those schools and daycare centers? Are more resources needed? Please explain.

In order to overcome COVID-19, US research and development is key to produce treatments and vaccines and save lives.

Have the additional US investments Congress has made in basic and applied research toward COVID-19 been sufficient? Is the funding being distributed and used effectively? Please explain.

“Coronavirus cases and hospitalizations have been climbing steadily in North Carolina for weeks as nonessential businesses and restaurants reopen[ed].” Now, people in the state will “be required to wear face coverings in public,” and NC has paused its reopening.

However, “law school graduates must take the [NC bar] exam in person July 28 and 29 unless they decide to wait for the next test in February 2021.” It is common for test-takers to travel from many different states to sit for a particular state’s bar exam. This could promote coronavirus transmission.

This is just one example of practices for addressing COVID-19 that appear to be contradictory. It’s confusing and hindering the overall US response to the pandemic.

What are your agencies doing to get federal, state, and local governments, as well as the private sector, on the same page about how to protect Americans’ health? What’s the plan?

During the H1N1 influenza pandemic in the US, from April 2009 to April 2010, there were about 61million cases, 275,000 hospitalizations, and 12,500 deaths. We have lost 10 times that number of Americans to COVID-19 in about three and a half months.

Did the country learn the right lessons from the H1N1 pandemic, and apply them appropriately? How or how not?

During this pandemic, contact tracing has proven to be a vital tool for curbing the number of cases of COVID-19.

Do you believe that the federal government is providing enough investment into contact tracing initiatives, or should there be an increase in funding directed towards effective contact tracing? Has the coordination of contact tracing programs been effective, and if not, what should be improved?

Drs. Hahn and Redfield, “federal prosecutors charged a Chinese manufacturer with exporting nearly a half million masks to the US that falsely purported to be N95 respirators, saying the subpar products could have put health-care workers at risk amid the coronavirus pandemic.”

Has there been effective coordination between FDA and NIOSH to ensure that defective or counterfeit N95 masks or other personal protective equipment is not being used by US health care workers? If not, how will coordination be improved? Dr. Fauci and Admiral Giroir, do you agree?

For all the witnesses, yes or no: Would all Americans wearing masks when in public help prevent the spread of COVID-19 and save lives?

Follow-up: What should be done to make this a reality? What do our political leaders and others that we look to in American society to set an example need to know?

Follow-up: Why did the CDC take so long to recommend wearing masks to the American public?

Tragically, hundreds of Americans continue to die every day from the coronavirus. 125,000 US lives, and counting. The Administration’s unsatisfactory response to the COVID-19 pandemic has contributed to avoidable deaths and other health impacts.

The Centers for Disease Control and Prevention, staffed by premier public health and communications experts, only recently “held its first public press briefing in three months.”

Why didn’t the scientists, physicians, and public health experts at CDC have had the lead on communicating with the American people throughout the entire COVID-19 pandemic? What is the Administration’s plan for giving the CDC a large platform to communicate with the American people about how we can stop surges of COVID-19 nationwide?

What are your perspectives on the success of therapies for COVID-19, such as monoclonal antibody treatments? Has any recent progress made you hopeful?

Follow-up: Is there enough existing manufacturing capacity in the US to produce a successful therapeutic at the volume that would be necessary to both treat patients and use it prophylactically? If not, what needs to be done now to make sure Americans can access a therapeutic?

Dr. Redfield, a Department of Health and Human Services review recently concluded that the initial CDC COVID-19 testing kits were likely contaminated.

What lessons has the CDC learned from this? Has the situation been rectified, and can we expect that contamination to be an isolated incident?

What level of public health, scientific, and statistics literacy would have been optimal to help Americans confront the pandemic? Would it have mattered? How can our national experience with COVID-19 inform how we educate the next generation of Americans?

Dr. Hahn, please describe any interactions between FDA and the White House related to efforts to make hydroxychloroquine more available.

Follow-up: On what evidence was the agency relying in making the EUA determination? Is this the typical amount of evidence the agency requires before issuing an EUA?

Follow-up: Dr. Hahn, why did you facilitate access to hydroxychloroquine for Dr. Zelenko, when his proposed use went beyond the confines of the EUA?

Follow-up: Do you now regret that the EUA was issued, especially given the deaths in FDA’s adverse event database due to HCQ-induced arrhythmias?

FDA has ceased most domestic inspections, conducting only 19 in the month of May (includes all products). By contrast FDA typically conducts over 1,000 inspections per month, and conducted 454 during its lowest month in 2019 (Which was in January, during the government shutdown).

Dr. Hahn, with stay at home orders being lifted and businesses resuming normal activities in many regions, why have FDA inspections not resumed?

Dr. Hahn, your agency terminated a Seattle-area effort that was studying the spread of COVID-19 after the research team failed to secure an FDA approval. The research team had tested 8,443 samples from volunteers for the coronavirus.

Outside experts criticized this move, saying that rather than shutting down the useful research effort, FDA could have worked with the research team to help them obtain the necessary approvals.

The coronavirus surveillance program is now back up and running, but valuable time was lost while it was shut down.

Please explain how FDA plans to avoid similar incidents in the future.

Dr. Hahn, FDA announced a guidance exempting food companies from having to declare “minor formulation changes” during the COVID-19 pandemic.  This creates a risk for consumers with allergies, especially rare allergies that may not be identified by companies as potential safety risks. Allergen and food labeling groups have asked that the FDA require companies to post information about these changes online. Does the FDA plan to require this? Why or why not?

Dr. Hahn, please describe any inspections FDA may have made of the numerous facilities producing coronavirus antibody tests.

Dr. Hahn, please explain why in mid-March the agency waived even EUA requirements for the antibody tests, at least for CLIA-certified laboratories. What then led the agency to backtrack and require an EUA? What assurance do we have that the current tests are performing adequately?

Dr. Hahn, why was Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, detailed over to the Commissioner’s office? What procedures are in place to ensure that she has no involvement in the review of products that she helped develop, avoiding potential conflicts of interest?

Dr. Hahn, can you discuss whether remdesivir, one of two drugs shown to have any positive impact on COVID-19 patients, has been granted priority review, accelerated approval, or breakthrough status?

Follow-up: Has the company that makes remdesivir submitted a New Drug and Therapeutic Biologics Application? If it does, will you announce it?

Dr. Hahn, please explain the circumstances surrounding the agency’s review of the initial diagnostic tests for SARS-CoV-2, the virus that causes COVID-19. It has been reported that the agency delayed review by requiring the submission of data in multiple forms.

Dr. Hahn, please describe what FDA encountered when it inspected the CDC testing laboratory, and coronavirus test manufacturing facility, in Atlanta. How would you characterize quality assurance in those labs compared to other laboratories FDA has inspected?

Dr. Hahn, is FDA able to monitor the market for dietary supplements making drug or disease claims? Does FDA require additional resources in order to do so effectively?

Dr. Hahn, has FDA taken any action to implement Executive Order #12349, regulatory relief to support economic recovery? If so, what? If not, are there any plans to do so?

Dr. Hahn, please describe FDA’s role in the coordination that is occurring under Operation Warp Speed as it pertains to ACTIV, the NIH vaccine initiative.

Follow-up: How does FDA plan to prevent any possible undue interference from the White House?

Public health experts and researchers have consistently recommended that the US dedicate more resources to infectious disease preparedness and response.

Had we known that COVID-19 was coming, what should have we done 3 years ago to prepare for it? How does that inform what we should be doing going forward to protect not only against this health crisis, but also against potentially catastrophic biological events that we may encounter in the future?

Dr. Redfield, the CDC website states that “the virus that causes COVID-19 has been found in untreated wastewater,” but that it is unknown “whether this virus can cause disease if a person is exposed to untreated wastewater or sewerage systems.”

The site goes on to say that “at this time, the risk of transmission of the virus that causes COVID-19 through properly designed and maintained sewerage systems is thought to be low.”

Meanwhile, in Wuhan, thousands of tons of disinfectant were used to treat the sewerage system there.

Do you have any new information to share on this aspect of COVID-19, especially considering violent summer storms have the potential to flood wastewater treatment or sewerage systems, possibly increasing the chances of people coming into contact with untreated wastewater?

Vice President Pence’s chief of staff owns shares in companies that are involved in the US response to COVID-19, such as 3M and Honeywell. This may represent a conflict of interest.

Dr. Hahn, does FDA have a process in place to ensure conflicted White House personnel cannot influence the advancement of products? If so, please describe how effective the process is. If not, why?

Quick reads

Review of the federal response to COVID-19 – Government Accountability Office WatchBlog, Highlights

How prepared are we for a pandemic? – GAO WatchBlog

Novel Coronavirus 2019: Global Implications and Responses – Congressional Research Service In Focus

Coronaviruses – GAO Science and Tech Spotlight

US faces long-standing challenges related to defending against biological threats – GAO Highlights

Capabilities and challenges of technologies to enable rapid diagnoses of infectious diseases – GAO Highlights

Presidential authority to mobilize US industry to mitigate coronavirus – CRS Insight

COVID-19: Current Travel Restrictions and Quarantine Measures – CRS Legal Sidebar

Primer on the World Health Organization – CRS In Focus

Deep dives

COVID-19: Opportunities to Improve Federal Response and Recovery Efforts – GAO Report

Overview of US Domestic Response to the COVID-19 Novel Coronavirus – CRS Report

Additional Efforts Would Enhance Likelihood of Effective Implementation of US National Biodefense Strategy – GAO Report

US faces long-standing challenges related to defending against biological threats – GAO Report

Capabilities and challenges of technologies to enable rapid diagnoses of infectious diseases – GAO Report

Exploring Lessons Learned from a Century of Outbreaks: Readiness for 2030 – National Academies of Sciences, Engineering, and Medicine Report

Global Health Risk Framework: Resilient and Sustainable Health Systems to Respond to Global Infectious Disease Outbreaks – NASEM Report

Resources

Press clips

Young people in the US South and West are increasingly getting coronavirus – CNN piece

More than two dozen states report coronavirus surges – Washington Post live updates

How the US and Italy traded places on coronavirus – Politico piece

Failures in US COVID-19 testing – Rolling Stone piece

How to prepare for a coronavirus pandemic – Foreign Affairs piece

The next plague is coming. Is America ready? – The Atlantic piece

Congressional correspondence

Press release from Senator Alexander (R, TN), chair of the Committee, calling for Congress to prepare this year for the next pandemic

Letter from a bipartisan group of Members of Congress to the Centers for Disease Control about the dissemination of novel coronavirus diagnostic tools to state and local jurisdictions

Letter from Senator Cotton (R, AK) to Department of Health and Human Services regarding information sharing with China

Letter from 31 Democratic Senators to Department of Health and Human Services regarding the US response to the novel coronavirus outbreak

Letter from Senator Hawley (R, MO) asking the Trump Administration about US-China travel restrictions

Letter from Senator Markey (D, MA) to the National Institute of Allergy and Infectious Diseases about novel coronavirus vaccine development efforts

Bipartisan bills

Ensuring Access to COVID-19 Preventive Care Act of 2020, H.R.6231

Cure the Coronavirus Act, H.R.6019

Coronavirus Relief Fund Flexibility Act, S.3638

Coronavirus Community Relief Act, H.R.6467

Coronavirus Worker Relief Act, H.R.6207

2020 Coronavirus Preparedness and Response Supplemental Appropriations Act, H.R.6074

Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, S.1379

Health Care Workforce Protection Act of 2019, H.R.4982

National Strategy for Pandemic Influenza Update Act, H.R.5730

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Contribute your nonpartisan, objective statements and questions. We will collate your submissions and post them here – anonymously – as part of this resource for policymakers. Submit via the form above, or to sciencepolicy@fas.org!