Source: US Government Accountability Office

Send in your ideas to help the Senate question Food and Drug Administration officials about COVID-19

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The coronavirus has killed over 100,000 people, and infected millions, in the US alone. As some areas of the country begin to lift infection control precautions, it is critical for the US response to the COVID-19 pandemic to improve.

The Senate Committee on Finance is holding a hearing to question officials from the Food and Drug Administration (FDA) and other experts about the US COVID-19 response.

The Committee wants to hear your thoughts on COVID-19 tests, clinical trials, vaccines, drug safety, biological therapeutics, medical devices, hand sanitizers, and supply chains, 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

FDA actions around COVID-19 tests, clinical trials, vaccines, drug safety, therapeutics, medical devices, supply chains, etc.

What: Senate Committee on Finance hearing – “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process.”

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

  • Judith A. McMeekin, Pharm.D. – Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs – Food and Drug Administration
  • Douglas Throckmorton, M.D. – Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research – Food and Drug Administration
  • Mark Abdoo – Associate Commissioner for Global Policy and Strategy – Food and Drug Administration
  • Mary Denigan-Macauley, Ph.D. – Director, Health Care – Government Accountability Office
  • Martin VanTrieste – President & Chief Executive Officer – CivicaRx
  • David Light – Founder and CEO – Valisure
  • Harry M. Lever, M.D. – Medical Director, Hypertrophic Cardiomyopathy Clinic – Cleveland Clinic

When: Tuesday, June 2 at 2:30pm ET

Where: 106 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 via the form below! Last updated Thursday 5/28/2020.

Dr. McMeekin, there are two main types of coronavirus tests. Viral tests are used to determine whether a person is currently infected with the coronavirus. Antibody tests are used to determine if a person had been infected with the coronavirus in the past.

The FDA has granted emergency use authorizations for nearly 70 COVID-19 tests. While no test is perfect, some tests used to diagnose COVID-19 may be missing up to 20 percent of positive cases.

What is the FDA doing to evaluate these tests, hold companies accountable for inaccurate tests, and protect the American people from the consequences of unreliable test results?

Follow-up: Was there any pressure on FDA officials to issue the emergency use authorization for the Abbot Labs ID NOW point-of-care test? If so, please describe.

Dr. McMeekin and Dr. Throckmorton, at the end of April, FDA cautioned against the use of the drugs hydroxychloroquine or chloroquine for COVID-19 outside of a hospital setting or a clinical trial due to the risk of heart rhythm problems. Data indicate that hydroxychloroquine is not an effective treatment for COVID-19, and that it may even harm COVID-19 patients.

It was recently reported that, since early April, the FDA commissioner was in direct communication with a medical doctor who was bullish on prescribing hydroxychloroquine to his patients. Please explain how this influence impacted the FDA’s work, or affected how the FDA communicated with the public about hydroxychloroquine or chloroquine.

Follow-up: Have any other pressures, from the White House or elsewhere, impacted the FDA’s work, or affected how the FDA communicates with the public about hydroxychloroquine or chloroquine, or any other potential COVID-19 medicines or vaccines?

Dr. McMeekin, your agency recently 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 have 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.

It’s reported that the research team is in ongoing discussions with the FDA to determine the path to resuming the study. What is the current status of these discussions, and what is FDA doing to work with the research team to bring the study back online as soon as possible?

Follow-up: Please explain how FDA plans to avoid similar incidents in the future.

Dr. McMeekin and Dr. Denigan-Macauley, experts like Dr. Anthony Fauci have predicted a likely resurgence of COVID-19 in the fall. What testing supplies, personal protective equipment, medicines, and so on, need to be invested in right now in order for the US to be prepared? Please explain.

Follow-up: What are the metrics for tracking this effort, and what benchmarks need to be met?

Dr. McMeekin and Dr. Denigan-Macauley, one of the main functions of the federal government is to provide for the security of its citizens. In the face of the coronavirus pandemic, the Administration has not performed well. For example, public health often had to compete with economic and political considerations in internal debates, which slowed the path toward belated decisions to seek more money from Congress, obtain necessary supplies, and address shortfalls in testing.

As some of the White House’s efforts have been counterproductive, what ground is most important for the FDA to make up in the near-term, and in the long-term? What can Congress do to support FDA’s work?

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. McMeekin and Mr. Abdoo, please explain the concerns related to manufacturing quality for hydroxychloroquine at the Ipca Laboratory facilities in India. To your knowledge, has the Office of Compliance ever issued a similar waiver permitting importation before?

Dr. McMeekin and Mr. Abdoo, please describe any inspections FDA may have made of the numerous facilities producing coronavirus antibody tests.

Dr. Throckmorton, do you agree with the decision to issue an emergency use authorization – EUA – for hydroxychloroquine? 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? In your experience, is this the typical amount of evidence the agency requires before issuing an EUA? 

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

Dr. Throckmorton, 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. Throckmorton, 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. Throckmorton, can you discuss whether remdesivir, the only drug that has been shown to have any positive impact on COVID-19 patients, has been granted priority review, accelerated approval, or breakthrough status?

Dr. Throckmorton, 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. Throckmorton, 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. Throckmorton, 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. Throckmorton, has the agency 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?

FDA has ceased most domestic inspections, conducting only 13 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). With stay at home orders being lifted and businesses resuming normal activities in many regions, why have FDA inspections not resumed?

FDA recently 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?

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

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.

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?

Your evidence-based question could be here!

Quick reads

Analysis of hydroxychloroquine and chloroquine – Congressional Research Service Insight

COVID-19 vaccine development – Government Accountability Office Science and Tech Spotlight

COVID-19 testing – CRS In Focus, GAO Science and Tech Spotlight

FDA regulation of personal protective equipment and ventilators – CRS In Focus

Novel Coronavirus 2019: Global Implications and Responses – CRS 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

Primer on the World Health Organization – CRS In Focus

Deep dives

Safety and efficacy reviews of drug applications by the FDA – GAO Report

China COVID-19 medical supply chains – CRS Report

FDA program to incentive development of low-profit drugs for public health emergencies – 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

Progress toward COVID-19 drugs or vaccines – Washington Post piece

COVID-19 continues to disrupt prescription drug supplies – New York Times piece

COVID-19 antibody tests – Wall Street Journal piece

FDA approves start of larger trial for a coronavirus vaccine – New York Times piece

US authorizes use of anti-viral drug remdesivir – BBC News piece

FDA halts Seattle-area COVID-19 study over approvals – STAT piece

FDA finds high levels of carcinogen in diabetes drug metformin – New York Times piece

Congressional correspondence

Senators Warren (D, MA) and Murray (D, WA) urge FDA to monitor potential COVID-19 medical products to ensure the health and safety of Americans – letter

Senator Enzi (R, WY) questions FDA on plan to implement emergency use of COVID-19 drugs – letter

Senator Baldwin (D, WI) calls for investigation into the Administration’s actions on hydroxychloroquine – letter

Senators Ernst (R, IA) and Grassley (R, IA) call on FDA to clarify hand sanitizer rule – letter

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

Engage and take action!

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!