TESTIMONY

OF

ROBERT M. CALIFF, MD

COMMISSIONER OF FOOD AND DRUGS

FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

BEFORE THE

COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

UNITED STATES SENATE

AN UPDATE ON THE ONGOING FEDERAL RESPONSE TO COVID-19: 

CURRENT STATUS AND FUTURE PLANNING

JUNE 16, 2022

RELEASE ONLY UPON DELIVERY
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Introduction

Chair Murray, Ranking Member Burr, distinguished members of the Committee, thank you for 

the opportunity to testify before you today to describe the Food and Drug Administration’s 

(FDA’s or the Agency’s) coronavirus disease 2019 (COVID-19) response efforts. All of our 

efforts are in close coordination and collaboration with our partners, both within the Department 

of Health and Human Services (HHS) and across the federal government, to help ensure the 

development, authorization, licensure, approval, and availability of critical, safe, and effective 

medical products to address the COVID-19 public health emergency.

I want to note that this testimony is just a snapshot of some of our extensive work and is in the 

context of efforts across the Agency to address this pandemic. There are thousands of FDA 

employees who have been working on COVID-19 response efforts non-stop since the start of the 

pandemic. I want to commend and recognize their efforts and thank them for their dedication 

and service. I also want to thank all FDA employees who have continued to work on the myriad 

issues the Agency is responsible for that do not directly involve COVID-19.

From the beginning of this public health emergency, FDA has taken an active leadership role in 

the all-of-government response to the COVID-19 pandemic, inspired by the resiliency of the 

American people and our great innovators. FDA stood up an intra-agency group that continues 

to ensure we are doing everything possible to protect the American public, help ensure the 

safety, efficacy, and quality of FDA-regulated medical products, and provide the industries we 

regulate with the guidance and tools to do the same. We continue to focus on facilitating the 

development and availability of medical countermeasures to diagnose, treat, and prevent 

COVID-19, surveilling the medical product and food supply chains for potential shortages or 

disruptions, and helping to mitigate such impacts, as necessary to protect the public health. 

This includes working to quickly address any potential impacts of new variants. FDA continues

to evaluate the potential impact of new variants on the currently available diagnostics, 

therapeutics and vaccines. We are closely monitoring changes to the virus and are committed to 

communicating with the public as we learn more. In response to the omicron variant, we 
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updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page1 to share new 

information on the variants and their impact on antigen diagnostic tests. FDA is committed to 

continuing to use every tool in our toolbox to fight this pandemic, including pivoting as the virus 

adapts, to arm ourselves with the best available diagnostics, life-saving therapeutics and vaccines 

to fight this virus.

At this time, the current vaccines remain highly effective at preventing serious clinical outcomes 

associated with a COVID-19 infection, including hospitalization and death. Additionally, 

currently available data from our international partners and vaccine manufacturers that has been 

evaluated by the Agency, suggests that an additional booster shot following the completion of a 

primary vaccination provides further protection. Data also suggest a second booster dose of 

either the Pfizer-BioNTech Vaccine or Moderna COVID-19 Vaccine could help increase 

protection levels for certain higher-risk individuals.

Getting vaccinated or receiving a booster with one of the currently available vaccines is the best 

thing Americans can do right now, in addition to standard precautions like wearing a mask, to 

help protect themselves and their families.

Biologics, Including Vaccines 

FDA’s Center for Biologics Evaluation and Research (CBER) continues to use every tool 

available to help facilitate the development and availability of vaccines and other biological 

products to combat the COVID-19 pandemic expeditiously and safely.

CBER is working on multiple fronts to address the COVID-19 pandemic, including:

• Helping to facilitate expedited clinical trials for vaccines and certain therapeutic 

biological products that hold promise to prevent or treat COVID-19 by providing timely

interactions, scientific advice, and recommendations for individual sponsors and through 

issuance of guidance documents;

1 https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutationsimpact-covid-19-tests
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• Supporting product development and facilitating the scaling up of manufacturing capacity 

for high priority products to treat COVID-19 and conducting timely reviews;

• Expediting the review of Emergency Use Authorization (EUA) requests and Biologics 

License Applications (BLAs) for vaccines and other critical medical products to address 

COVID-19, including the evaluation of booster doses of COVID-19 vaccines and the use 

of COVID-19 vaccines in certain pediatric populations;

• Helping to ensure an adequate and safe blood supply; and

• Providing information to healthcare providers and researchers to help them submit 

expanded access investigational new drug application (IND) requests to permit the use of 

CBER-regulated investigational products for patients with COVID-19.

CBER’s work on COVID-19 vaccines, as discussed below, has made a tremendous difference in 

addressing the pandemic by facilitating the availability of COVID-19 vaccines that meet the 

Agency’s rigorous standards as expeditiously as possible. Through our transparent scientific 

evaluation process, FDA has issued EUAs for three COVID-19 vaccines: the Pfizer-BioNTech 

COVID-19 Vaccine for use in individuals 5 years of age and older; the Moderna COVID-19 

Vaccine for use in individuals 18 years of age and older; and the Janssen COVID-19 Vaccine for 

use in certain individuals 18 years of age and older. FDA has also approved Comirnaty (known 

as Pfizer-BioNTech COVID-19 Vaccine under the EUA) for use in individuals 16 years of age 

and older and Spikevax (known as the Moderna COVID-19 Vaccine under the EUA) for use in 

individuals 18 years of age and older. In doing so, we have relied upon the Agency’s rigorous 

standards for safety, effectiveness, and manufacturing quality. These COVID-19 vaccines were 

developed without cutting corners or compromising our regulatory and scientific standards. 

Intensive interactions between FDA and manufacturers minimized the time between different 

studies in the clinical development process; allowed seamless movement throughout the different 

phases of clinical trials; and simultaneously facilitated manufacturers proceeding with 

manufacturing scale-up before it was clear whether the safety and effectiveness data for a 

vaccine would support an EUA, allowing for quicker access to products once FDA reviewed the 

data and found the products met the Agency’s rigorous standards for authorization or approval.

For the approved vaccines, as well as those that have been authorized for emergency use, our 

process included a thorough evaluation of the data by the Agency’s career staff. We also 
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solicited input from independent scientific and public health experts through our public advisory 

committee meetings for the COVID-19 vaccines that we have authorized. Throughout our 

scientific and regulatory process, FDA took additional steps to facilitate transparency, such as 

posting sponsor and FDA briefing documents and key decisional memoranda.

The COVID-19 vaccines that are available in the United States have shown clear and compelling 

efficacy in large, well-designed phase 3 trials. These vaccines are helping the country in the fight 

against this pandemic and have met FDA’s rigorous standards for safety and effectiveness to 

support either EUA or approval. The vaccines are approved or authorized to prevent COVID-19, 

and have been shown to significantly reduce the associated serious outcomes, including 

hospitalization and death. 

As part of our continued efforts to be transparent and educate the public, we have a wealth of 

information on our website about the COVID-19 vaccines available for use in the United 

States. The information includes fact sheets for healthcare providers (vaccination providers) and 

fact sheets for vaccine recipients and caregivers in multiple languages, with important 

information such as dosing instructions; information about the benefits and risks of each vaccine; 

and topical Questions and Answers developed by FDA for the approved vaccines and each 

authorized vaccine.2

It is also important to highlight that, as part of each EUA or approval, manufacturers and 

vaccination providers are required to report serious adverse events, cases of Multisystem 

Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death to 

the Vaccine Adverse Event Reporting System (VAERS), a national vaccine safety surveillance 

program jointly run by FDA and the Centers for Disease Control and Prevention (CDC).

COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of 

health problems following COVID-19 vaccination very seriously. FDA and CDC have 

implemented a coordinated and overlapping approach for continuous safety monitoring of all 

2 https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-

frequently-asked-questions
5

COVID-19 vaccines using state-of the art technologies. Specifically, the Agency’s monitoring 

following authorization of the COVID-19 vaccines uses a multi-pronged approach including: 

1) passive surveillance using VAERS consisting of safety reports submitted by healthcare 

providers,

3 patients, parents and other members of the public; combined with 

2) active surveillance, using large population-based healthcare datasets. 

These latter healthcare data systems offer a higher likelihood of detecting rare adverse events 

because they capture medical data on millions of Americans, cover diverse subpopulations (i.e., 

pregnant women, elderly, and patients with comorbidities), and can provide a longer duration of 

follow-up when compared to the prelicensure clinical studies. In addition, COVID-19 vaccine 

recipients are encouraged to enroll in CDC’s v-safe After Vaccination Health Checker 

smartphone-based tool that uses text messaging and web surveys to check-in with vaccine 

recipients over time after they receive a COVID-19 vaccine. Through v-safe, they can quickly 

tell CDC if they have any side effects after getting a COVID-19 vaccine. Together, the passive 

and active safety surveillance provide a coordinated and overlapping approach to vaccine safety 

monitoring for COVID-19 vaccines. 

On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The vaccine 

previously known as the Pfizer-BioNTech COVID-19 Vaccine was approved and marketed as 

Comirnaty for the prevention of COVID-19 in individuals 16 years of age and older. The PfizerBioNTech COVID-19 Vaccine has continued to be available under an EUA and is currently 

authorized as a: 

• Two-dose primary series for individuals 5 years of age and older; third primary series 

dose for individuals 5 years of age and older with certain immunocompromising 

conditions; 

• homologous first booster dose (matching the primary vaccination) administered at least 5 

months after completion of primary vaccination to individuals 5 years of age and older; 

3 Providers in the CDC COVID-19 Vaccination Program are required to report certain adverse events following 

COVID-19 vaccination to VAERS
6

• heterologous first booster dose (not matching the primary vaccination) administered after 

completion of primary vaccination to individuals 18 years of age and older (the dosing 

interval is the same as that authorized for a booster dose of the vaccine used for primary 

vaccination); 

• homologous second booster dose administered at least 4 months after a first booster dose 

to individuals 50 years of age and older and individuals 12 years of age and older with 

certain immunocompromising conditions; and 

• heterologous second booster dose administered at least 4 months after a first booster dose 

to individuals 50 years of age and older and individuals 18 years of age and older with 

certain immunocompromising conditions. 

On January 31, 2022, FDA approved a second COVID-19 vaccine. The vaccine has been known 

as the Moderna COVID-19 Vaccine; the approved vaccine is marketed as Spikevax for the 

prevention of COVID-19 in individuals 18 years of age and older. The Moderna COVID-19 

Vaccine has continued to be available under an EUA and is currently authorized as a: 

• Two-dose primary series for individuals 18 years of age and older; 

• third primary series dose for individuals 18 years of age and older with certain 

immunocompromising conditions; 

• homologous or heterologous first booster dose administered after completion of primary 

vaccination to individuals 18 years of age and older (the authorized dosing interval for a 

homologous booster is at least 5 months after completion of a primary series, and the 

authorized interval for a heterologous booster is the same as that authorized for a booster 

dose of the vaccine used for primary vaccination); and 

• a homologous or heterologous second booster dose administered at least 4 months after 

the first booster dose to individuals 50 years of age and older and individuals 18 years of 

age and older with certain immunocompromising conditions.
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The Janssen COVID-19 Vaccine was originally authorized on February 27, 2021. On May 5, 

2022, FDA limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years 

of age and older for whom other authorized or approved COVID-19 vaccines are not accessible 

or clinically appropriate, and to individuals 18 years of age and older who elect to receive the 

Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.

At this time FDA is closely monitoring the emergence of new variants in order to determine 

what, if anything, needs to be changed in the composition of COVID-19 vaccines moving 

forward to best protect the population. The Agency has already issued COVID-19 vaccinespecific guidance to address the emergence and potential future emergence of variants of SARSCoV-2, the virus that causes COVID-19.4

FDA recently held the following virtual meetings of its Vaccines and Related Biological 

Products Advisory Committee (VRBPAC) related to emergency use requests that have been 

publicly announced by COVID-19 vaccine manufacturers.

• On June 7, FDA convened VRBPAC to discuss an EUA request for a COVID-19 vaccine 

manufactured by Novavax to prevent COVID-19 in individuals 18 years of age and older.

• On June 14, FDA and its advisory committee of external experts met to discuss 

Moderna’s EUA request for 6 years through 17 years of age. 

• On June 15, FDA and its advisory committee of external experts met to discuss the 

Moderna EUA request for 6 months through 5 years of age and the Pfizer-BioNTech 

EUA request for 6 months through 4 years of age.

On June 28, FDA plans to convene the VRBPAC to discuss whether the SARS-CoV-2 strain 

composition of COVID-19 vaccines should be modified, and if so, which strain(s) should be 

selected for Fall 2022. This meeting is a follow-up to the April 6 VRBPAC meeting that 

4 Emergency Use Authorization for Vaccines to Prevent COVID-19, updated March 31, 2022: 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorizationvaccines-prevent-covid-19
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discussed general considerations for future COVID-19 vaccine booster doses and the strain 

composition of COVID-19 vaccines to further meet public health needs.
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Figure 1
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This pandemic is dynamic and evolving, with new data continuously emerging about vaccine 

safety and effectiveness. As we obtain more data about the safety and effectiveness of COVID19 vaccines, including the use of booster doses, we will continue to evaluate the rapidly 

changing science and keep the public informed. 

At this time, it is clear that the approved or authorized vaccines reduce the risk of severe illness; 

however, data are not yet available to make a determination about how long they will provide 

protection. Additionally, although we do not yet know the full range of SARS-CoV-2 variants 

that each of the vaccines will protect against, there is evidence that the available vaccines protect 

against severe disease caused by variants circulating in the United States.

To date, having three authorized vaccines and two approved vaccines that meet FDA’s 

expectations for safety and effectiveness at this point of the COVID-19 pandemic is a 

tremendous achievement and a testament to the dedication of vaccine developers and FDA’s 

career scientists and physicians. We are highly engaged in ensuring that all COVID-19 vaccines 

meet the high quality that the American public expects and deserves. The Agency is very proud 

of these efforts, and we believe that the vaccines will help bring this pandemic to an end.

In addition to its work on COVID-19 vaccines, CBER also has been actively involved in 

reviewing data related to COVID-19 convalescent plasma and on December 28, 2021, FDA 

updated the EUA for COVID-19 convalescent plasma. The update limits the authorization to the 

use of COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies for the 

treatment of COVID-19 in patients with immunosuppressive disease or who are receiving 

immunosuppressive treatment. These patients may be treated in outpatient or inpatient settings. 

Additionally, to help assure the manufacture of high titer COVID-19 convalescent plasma, the 

update to the EUA revises acceptable tests and increases qualifying result cutoffs to be used for 

manufacturing COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies.

Drug Products

Since the beginning of the COVID-19 pandemic, FDA’s Center for Drug Evaluation and 

Research (CDER) has been working tirelessly to facilitate the development and availability of 
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therapeutics for use by patients, physicians, and health systems as expeditiously and safely as 

possible. FDA accelerated the development and publication of guidance and other information 

for industry and researchers on developing COVID-19-related treatments. Further, FDA created

an emergency review and development program for possible therapies for COVID-19, the 

Coronavirus Treatment Acceleration Program, or “CTAP.” Under CTAP, FDA is using every 

available authority and regulatory flexibility to facilitate the development of safe and effective 

products to treat patients with COVID-19. As of May 31, 2022, there are more than 700 drug 

development programs in the planning stages and the Agency has reviewed more than 460 trials 

of potential therapies for COVID-19. These therapies include antivirals, immunomodulators, 

neutralizing antibodies, and combinations of these products, as well as cell and gene therapies

regulated by CBER. The diversity of therapeutic approaches being investigated is important 

because it rapidly expands our understanding of the effect of different categories of potential 

treatments. 
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Figure 2 

CTAP Snapshot as of May 31, 2022

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As of May 31, 2022, FDA has approved two drugs to treat COVID-19 and currently there are 

thirteen authorized therapeutics for emergency use. On December 8, 2021, FDA issued an EUA 

for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered 

together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and 
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pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 

pounds]). 

On December 22, 2021, FDA issued an EUA for the first oral antiviral, Paxlovid, manufactured 

by Pfizer. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) is 

authorized for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and 

pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) 

with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to 

severe COVID-19, including hospitalization or death. In the large clinical trial that was 

conducted among high-risk patients, Paxlovid reduced the risk of hospitalization or death by 

nearly 90 percent compared to placebo. 

On December 23, 2021, FDA issued an EUA for another oral antiviral, molnupiravir, 

manufactured by Merck. Molnupiravir is authorized for the treatment of mild-to-moderate 

coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral 

testing, and who are at high risk for progression to severe COVID-19, including hospitalization 

or death, and for whom alternative COVID-19 treatment options authorized by FDA are not 

accessible or clinically appropriate. 

On February 11, 2022, FDA issued an EUA for bebtelovimab, manufactured by Eli Lilly and 

Company. Bebtelovimab is authorized for the treatment of mild-to-moderate coronavirus disease 

(COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg or 

about 88 pounds) with positive results of direct SARS-CoV-2 viral testing, and who are at high 

risk for progression to severe COVID-19, including hospitalization or death, and for whom 

alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically 

appropriate.

In considering EUA requests for therapeutics, we promptly and carefully evaluate the totality of 

the scientific evidence to determine whether the statutory criteria for issuance under section 564 

of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3) are met. 

Among other criteria, this evaluation considers whether the product may be effective for its 
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proposed authorized uses, and whether the product’s known and potential benefits when used as 

proposed outweigh the known and potential risks of such product. 

Our goal is to be as transparent as possible about the scientific basis for recommending that a 

drug or biological product be authorized for emergency use under section 564 of the FD&C Act 

or for recommending that an EUA be revised or revoked.6

FDA continues to work closely with manufacturers to mitigate and prevent shortages as the 

COVID-19 pandemic evolves. For example, the Agency has issued four EUAs to authorize the 

emergency use of certain therapeutic products intended to treat serious or life-threatening 

diseases or conditions (e.g., Acute Kidney Injury, Acute Respiratory Distress Syndrome) caused 

by COVID-19 after determining that sufficient FDA-approved alternatives to these products 

were not available to fully meet the emergency need. This has helped to alleviate shortages of 

some therapies that are essential for the care of critically ill COVID-19 patients. FDA is 

working with manufacturers to increase supplies to meet current demand by expediting review of 

applications. In addition, the Agency has prioritized the review of generic drug applications for 

potential treatments and supportive therapies for patients with COVID-19, such as sedatives used 

in ventilated patients, anticoagulants, and pulmonary medications. In June 2021, FDA reached a 

milestone of approving 1,000 original and supplemental generic drug applications since the start 

of the pandemic to help in the treatment of patients with COVID-19. This supports FDA’s 

everyday mission of improving access to safe, effective, high-quality treatment options, 

especially during the COVID-19 pandemic. 

Medical Devices 

FDA’s work to support access to devices for the COVID-19 response began in January 2020 –

before the public health emergency was declared in the U.S. and two months before the 

pandemic was declared worldwide – due to the immediate need for COVID-19 tests and testing 

supplies, collection kits, personal protective equipment (PPE), ventilators, and other devices. The

need for medical devices to respond to the COVID-19 pandemic has far exceeded what we 

experienced in any prior public health emergency. The first EUAs issued for the COVID-19 

6 https://www.fda.gov/news-events/press-announcements/covid-19-update-fdas-ongoing-commitment-transparencycovid-19-euas
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public health emergency were for medical devices, and the volume of EUA requests quickly 

surpassed (by two orders of magnitude) that of any prior public health emergency or other 

situation. To help combat the COVID-19 pandemic, FDA and the staff of the Center for Devices 

and Radiological Health (CDRH) have continued to go well beyond normal operating procedures 

to help ensure the availability of appropriately safe and effective COVID-19-related devices as 

quickly as possible. From early in the pandemic, CDRH has actively reached out to and engaged 

other government agencies, medical device developers and international regulatory agencies, 

among other stakeholders. CDRH continues to hold weekly virtual town halls with industry to 

address COVID-19 test development and validation, as well as additional webinars and town 

halls addressing other policies and questions including PPE, 3D-printed swabs and 

manufacturing disruptions during the public health emergency. CDRH staff have also interacted 

frequently with test developers and manufacturers through the Pre-Emergency Use Authorization 

(pre-EUA) process, including rolling reviews of information that helped to further expedite EUA 

of critical medical devices for patients and health care professionals on the front lines. Since 

January 2020, FDA has received more than 8,000 EUA requests and Pre-EUA submissions for 

devices (including more than 1,000 so far in fiscal year 2022). The emergency use requests 

included submissions for devices that CDRH had never received EUA requests for during prior 

public health emergencies. This included ventilators and novel devices such as extracorporeal 

blood purification devices, as well as novel indications for devices such as continuous renal 

replacement therapy devices. CDRH continues to receive nearly 120 EUA requests and preEUA submissions each month, the majority for in vitro diagnostic (IVD) tests, and has begun 

receiving conventional submissions from firms intending to transition their products beyond 

emergency use.

Since the start of the pandemic, FDA has issued EUAs or granted marketing authorization to 

nearly 2,300 medical devices for COVID-19-related uses. In addition, FDA rigorously monitors 

safety signals and medical device reports, using the information to publish 23 letters to 

healthcare providers and 14 safety communications. FDA completed other pivotal work activities 

such as addressing supply chain shortages and counterfeit products related to COVID-19.

Diagnostic tests are the first line of defense in an outbreak, and FDA plays an important role to 

ensure these tests work through the EUA review. The EUA process expedites access to 
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appropriately accurate diagnostic tests during emergencies, when, without such access,

information gaps and false results could adversely affect individual patient care and public health 

decision making. Through this process, molecular diagnostic tests are able to be developed, 

validated, authorized, and deployed within weeks rather than several months to over a year, as is 

typical for test development and traditional premarket submissions. The Agency employed its 

EUA authorities to facilitate availability of tests in six previous emergencies. Careful review of 

tests is critical because false test results can adversely impact the nation’s response. In public 

health emergencies, FDA is generally open to receiving and reviewing EUA requests for tests 

from any developer, including commercial kit manufacturers and laboratories, for tests that 

address the public health need. 

FDA sought to facilitate COVID-19 test evaluation and authorization through the development 

and availability of templates for EUA requests. The templates provide recommendations for test 

validation and a fill-in-the-blank form to streamline the paperwork and make it easier for 

developers to provide information in support of a request for an EUA. Since providing the first 

template in January 2020, FDA has been in daily contact with test developers to answer 

questions and help them through the EUA process. This has proved to be a helpful tool for 

many. FDA had as many as ten posted templates and continues to update, add, combine, and 

remove templates as the science evolves and as necessary to support developers of COVID-19 

tests. As of April 13, 2022, these templates have received over 618,543 hits from those visiting 

FDA’s website. FDA also supported test developers through establishment of a dedicated 

mailbox, 24-7 toll-free hotline that ran until July 2020, the posting of over 100 frequently asked 

questions on our website, and by hosting 86 virtual town halls for test developers. 

FDA has prioritized review of EUA requests for at-home tests since Spring 2020 – almost a year 

before other countries pursued expansive use of home tests – and has consistently actively 

engaged with test developers to support their development. To date, FDA has authorized 19 

distinct over-the-counter (OTC) COVID-19 tests, 11 of which were authorized in four weeks or 

less, with five authorized within a week. The Agency first discussed this prioritization in the 

Spring of 2020, during one of its weekly virtual Town Halls on COVID-19 tests, due to their 

potential impact on test accessibility and public health. To further encourage such test 

development, on July 29, 2020, FDA posted a template for at-home diagnostic tests. This 
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template includes recommendations for validating OTC tests for screening asymptomatic 

individuals with general performance expectations that are lower than for lab-based tests. The 

Agency recognizes the benefits of increased availability of OTC tests, and these 

recommendations have helped to increase OTC screening test availability, particularly rapid 

antigen tests. 

Throughout the pandemic, FDA has also monitored evolving circumstances and growing 

scientific knowledge and made adjustments when appropriate to help streamline and expedite the 

path to market for these and other tests as much as possible while assuring they are supported by 

sound science. In March 2021, FDA obtained results from a National Institutes of Health (NIH)-

sponsored study that supported further streamlining of FDA’s at-home test recommendations. 

Based on these data, on March 16, 2021, FDA issued an EUA that provides a streamlined path to 

authorize tests with at least 80 percent sensitivity in symptomatic individuals, with sensitivity 

falling in a range as low as 70 percent in certain circumstances, for developers to offer their test 

for OTC serial screening without additional data collection. Multiple tests were authorized under 

this approach within weeks.

FDA authorized the first at-home test on November 17, 2020. At-home tests, also referred to as 

self-tests, are those that can be performed by a lay user at home, or in other settings, with a selfcollected sample. As of June 1, 2022, the 19 authorized OTC at-home tests have a combined

manufacturing capacity of hundreds of millions of tests per month based on data provided to 

FDA by the manufacturers, and we understand many have scaled beyond their initial estimated 

capacity with additional government support.

FDA further streamlined the process for manufacturers developing over-the-counter at-home 

tests on October 25, 2021, by facilitating at-home single-use testing for symptomatic individuals 

for tests currently authorized only for serial testing. Developers of certain tests may request 

authorization to add single-use testing for symptomatic individuals without submitting additional 

data. This change would allow tests authorized for single use to be sold in singles, meaning more 

individual tests for sale potentially at a lower price.

On November 15, 2021, FDA published an update to its Policy for Coronavirus Disease-2019 

Tests During the Public Health Emergency that describes our review priorities based on the 
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current needs of the pandemic. In that update, FDA stated that going forward, the Agency

generally intends to focus its review on EUA requests for the following types of tests: 

• At-home and point-of-care (POC) diagnostic tests that can be manufactured in high 

volumes;

• Certain high-volume, lab-based molecular diagnostic tests (and home collection kits for 

use with such tests) that expand testing capacity or accessibility such as through pooling 

of specimens to increase throughput, testing specimens collected at home and shipped to 

the lab, screening asymptomatic individuals or detecting multiple different respiratory 

viruses at once;

• Certain lab-based and POC high volume antibody tests that can measure the amount of 

antibodies (fully quantitative antibody tests) or the amount of neutralizing antibodies; and 

• Tests for which the request is from, or supported by, a U.S. government stakeholder, such 

as the Biomedical Advanced Research and Development Authority or NIH’s Rapid 

Acceleration of Diagnostics (RADx) initiative. 

These priorities help developers focus their prospective efforts where they are most needed and 

reduce inefficient use of developer and FDA time on tests with less public health impact. 

Ultimately, we anticipate we will receive EUA requests only for those tests identified in the 

guidance for which the public health need is greatest, and we will be able to focus our attention 

on the review of such tests.

FDA also partnered with the NIH to establish the Independent Test Assessment Program 

(ITAP),

7 which streamlines validation and authorization of at-home antigen tests with potential 

for large-scale manufacturing. This program is an extension of the NIH RADx program which 

has already supported development of several authorized tests, including the first OTC COVID19 test. ITAP also supports studies on OTC tests and works with companies to provide complete, 

high-quality submissions for FDA review. The first two successful candidates to come through 

7 https://www.hhs.gov/about/news/2021/10/25/new-hhs-actions-add-biden-administration-efforts-increase-accesseasy-use-over-counter-covid-19-tests.html
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this process were authorized by FDA in the last week of 2021, which was weeks, if not months, 

ahead of schedule. FDA has authorized five OTC, at-home COVID-19 tests that participated in 

this program through this accelerated pathway – one manufactured by SD Biosensor and 

distributed by Roche, one manufactured by Siemens, a third manufactured by Maxim 

Biomedical, a fourth manufactured by Osang, LLC, and a fifth manufactured by Xiamen Boson 

Biotech Co., Ltd.8 We are already seeing shorter review times for such EUA requests due to our 

partnership with ITAP in establishing the evaluation program that provides high quality data. 

The average FDA review time for a test evaluated under ITAP is just over a week, and can be as 

short as one day, after receipt of a complete data package.

Going forward, FDA continues to take steps to increase access to reliable, accurate rapid antigen 

tests. This includes continuing to prioritize review of EUA requests for at-home antigen tests and 

increasing staffing on the antigen test review team as resources permit. FDA is actively working 

to increase the pipeline of at-home tests by engaging with companies to obtain data that can be 

used to support their EUA, working with developers with authorized POC tests to expand their 

authorization for at-home use, continuing support of ITAP and engagement with RADx and 

international regulators, and conducting targeted outreach to manufacturers of home tests in nonU.S. markets. 

To date, FDA has engaged with over 1,000 developers and authorized more than 475 tests and 

sample collection devices that provide a wide array of test options. In addition to at-home 

diagnostic tests, these include other types of molecular and antigen tests, as well as serology 

tests; POC tests, home collection tests, multi-analyte tests that can detect both COVID-19 and 

flu; tests using various sample types, including saliva tests; and tests for pooling, screening, and 

serial testing.9 Most recently, FDA issued an EUA for the first COVID-19 diagnostic test that 

detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.10

8 https://www.nibib.nih.gov/covid-19/radx-tech-program/ITAP 9 https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medicaldevices/in-vitro-diagnostics-euas 10 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid19-diagnostic-test-using-breath-samples
20

As noted in Figure 3 below, as part of this effort, FDA has authorized 302 molecular tests and 

sample collection devices, 84 antibody and other immune response tests, and 49 antigen tests. 

We have also authorized 34 tests for serial screening programs (27 antigen and seven molecular). 

The volume and variety of authorized tests is a testament to FDA’s support of innovative test 

design and our commitment to public health. FDA will continue to adapt to address public 

health needs and increase access to tests for consumers, including at-home diagnostic tests, 

adopting an approach that is grounded in sound science.

Figure 3

In addition to these efforts, FDA has been actively monitoring for the possible emergence of 

SARS-CoV-2 variants since early in the pandemic and has worked with test developers when a 

new variant (or mutation) emerges that could impact test performance. FDA also works with test 

developers, who are required to monitor their authorized test for the impact of viral 

mutations. As FDA’s or the developer’s analysis identifies tests whose performance could be 

impacted by SARS-CoV-2 viral mutations, these tests are added to FDA’s SARS-CoV-2 Viral 

Mutations: Impact on COVID-19 Tests webpage.

11 This includes posting the latest information 

11 https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutationsimpact-covid-19-tests
21

on the omicron variant and testing implications as they become available. FDA also works with 

other agencies and divisions in HHS, such as NIH, as we monitor tests for potential effects of 

genetic variation on test performance on an ongoing basis. 

FDA has authorized a wide variety of other medical devices for use in combating the pandemic, 

including a wide range of PPE, ventilators, and other therapeutic devices. As of May 31, 2022, 

FDA authorized 274 PPE devices, including 56 surgical masks, 205 filtering facepiece 

respirators (FFRs), and issued 13 EUAs for face shields and other barriers intended to protect the 

user from bodily fluids, liquid splashes, or potentially infectious materials. See Figure 4. In 

addition to issuing EUAs, CDRH has reviewed 510(k)s for and cleared over 1,400 devices that 

can be used for COVID-19 and certain similar diseases, including in future pandemics, with over

500 devices in fiscal year 2022 to date.

Figure 4

Since early 2020, FDA has adopted agile, interactive, and innovative approaches to review EUA 

requests for all types of devices. For example, FDA developed the umbrella EUA approach to 

efficiently authorize multiple devices of the same type falling within the scope of authorization 

and meeting the statutory criteria for issuance. The Agency has also issued 28 guidance 

documents outlining policies to help expand the availability of medical devices needed in 

response to COVID-19. For example, to help quickly increase availability of tests in the early 
22

stages of the pandemic, FDA outlined a policy for developers of certain tests who offered their 

tests, upon validation and notification to FDA, while Agency review of the EUA request was 

pending. Additionally, FDA outlined flexible approaches for manufacturers of certain cleared 

and approved devices (e.g., remote monitoring systems, ventilators, infusion pumps) regarding 

certain limited modifications made to devices without submitting a premarket submission.

Further, FDA made several improvements to our EUA review processes to make the most 

efficient use of our resources, including a front-end triage process to identify devices that would 

have the greatest impact on the public health. These improvements incorporate the latest 

information on device availability and shortages, prioritizing novel or critical devices not yet 

available on the market or those that would address significant device shortages. 

For medical devices, review times have increased over time as the number of EUA requests and 

Pre-EUA submissions for medical devices have increased to unprecedented levels. This is 

demonstrated in the tables we have provided with review times for IVD EUA requests over time, 

and submission volume for IVD EUA requests over time (see Figures 5 & 6 below). At the 

beginning of the pandemic, FDA was authorizing tests and other devices in as little as 1 or 2 

days upon receipt of complete data packages. Congress has provided critical, one-time funding 

that FDA has used to leverage contractors from outside organizations, to provide technical 

expertise to supplement our review staff in the review of EUA requests and other marketing 

submissions. These personnel are authorized to work alongside full-time employees, integrated 

into our internal review teams to help with the massive workload for tests, ventilators, PPE, and 

other devices, but the workload has continued to greatly exceed capacity even with the additional 

support. 
23

Figure 5

Figure 6

0

20

40

60

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120

Average FDA Review Time (Days)

Average FDA Review Time for Authorized COVID19 Tests

Molecular Serology Antigen Combined Average

0

500

1000

1500

2000

2500

3000

3500

Feb-20

Mar-20

Apr-20

May-20

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Aug-20

Sep-20

Oct-20

Nov-20

Dec-20

Jan-21

Feb-21

Mar-21

Apr-21

May-21

Jun-21

Jul-21

Aug-21

Sep-21

EUA Requests Received

Month

IVD EUA Request Volume

Molecular Serology Antigen Total
24

FDA has significantly improved IVD EUA review times. The average total time to decision

(TTD) for Original IVD EUAs received in CY 2021 is 54 days, with 91 percent of the 2021 

submissions closed.

Given the magnitude of the COVID-19 public health emergency, FDA recognizes that continued 

flexibility, while still providing necessary oversight, will be appropriate to facilitate an orderly 

and transparent transition back to the eventual resumption of normal operations. In December 

2021, FDA issued draft guidance for public comment to help manufacturers begin to plan a 

return to normal operations, including a proposed phased-in transition period and 

recommendations relating to submitting marketing submissions. As proposed, FDA would 

announce the Advance Notice of Termination (ANT) in the Federal Register, which would give 

manufacturers 180 days to come into compliance with regulatory requirements and submit a 

conventional marketing submission (e.g., 510(k) or PMA). Provided that the submission is 

accepted by FDA by this time (180 days after the ANT), FDA does not intend to object to these 

devices to continue to be distributed and used while the submission is pending review. FDA is 

working to address stakeholder feedback and timely finalize this guidance and a companion 

guidance for devices that fall within COVID-19-related enforcement policies. The transition plan 

for device EUAs and other actions FDA is undertaking are intended to provide transparency to 

our stakeholders and to avoid market disruptions and shortages as the Agency and broader device 

ecosystem transition back to normal operations.

FDA recognizes that medical devices, particularly tests, will continue to play an important role in 

the next phase of the pandemic response. The Agency is continuing to monitor its policies, the 

marketplace, and national needs, and will continue to adapt as the circumstances of the evolving 

pandemic warrant. 

Human and Animal Food (Center for Food Safety and Applied Nutrition, Center for 

Veterinary Medicine, and the Office of Food Policy and Response)

Throughout the pandemic, FDA has worked with federal, state, and local partners, as well as 

industry, to help ensure a safe and adequate food supply for both humans and animals.
25

While there is no evidence to show that SARS-CoV-2 is likely to be transmitted by food, some 

components of the food system are experiencing challenges and supply chain imbalances. We 

saw this at the outset of the pandemic with the dramatic shift in where people were eating, and 

most recently, we are seeing that the broad supply chain issues impacting so many commodities 

are also impacting food. Overall, food production and manufacturing in the U.S. has been 

remarkably resilient, but we continue to monitor the food supply and apply mitigation strategies 

for products for which availability has been impacted in part by pandemic-related issues.

In response to the pandemic, FDA’s Foods Program developed 21 Forward, a food supply chain 

data management tool, to help identify where risks for interruptions in the continuity of the food 

supply may be greatest. As part of 21 Forward, FDA conducted targeted outreach to the food 

industry to offer additional resources and technical assistance in addressing challenges. As 

highlighted in the U.S. Department of Agriculture’s (USDA’s) Agri-Food Supply Chain 

Assessment report, developed in response to Executive Order 14017 on America’s Supply 

Chains with input from FDA, a dynamic, interconnected, supply chain monitoring platform and 

robust data sets are necessary to be most effective in monitoring food supply chains, managing 

risks, and identifying and quickly addressing supply chain disruptions to reduce impacts on 

consumers.

FDA also recognizes that food supply chain stability and workers’ safety are two sides of the 

same coin. Thus, a stable and robust food supply depends on the safety and health of the 

nation’s food and agricultural workforce. Along with our federal, state, and local partners, we 

have provided best practices for food and agricultural workers, industry, and consumers on how 

to stay safe, and help ensure the continuity of operations in the food and agriculture critical 

infrastructure sector during the pandemic.

In collaboration with HHS, CDC, Health Resources and Services Administration (HRSA) and 

U.S. Department of Agriculture (USDA), data from 21 Forward on the estimated numbers and 

distribution of food and agricultural workers have been made available to assist states with their 

vaccine distribution efforts to workers in the food and agriculture sectors, including migratory 

and seasonal agricultural workers. In addition, FDA has worked with its Federal partners to 

provide both COVID-19 and flu vaccination encouragement messages for the food industry.
26

FDA’s Coordinated Outbreak Response and Evaluation team has been working throughout the 

pandemic looking for signs of foodborne illness outbreaks and initiating responses as needed. 

FDA’s Center for Veterinary Medicine (CVM) is monitoring the animal food supply and 

initiating needed foodborne illness and natural disaster responses. In terms of inspectional work, 

FDA’s Office of Regulatory Affairs (ORA) investigators continued to conduct mission-critical 

inspections domestically and abroad, including inspections and investigations in response to 

foodborne outbreaks, throughout the pandemic. FDA resumed standard operations for domestic 

surveillance inspections in July 2021, and since March 2022 has been conducting prioritized 

foreign inspectional work, including surveillance and other inspections. FDA continues to 

screen every line of every imported food shipment entering the U.S. utilizing our Predictive 

Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT) tool. We 

continually adjust the algorithm in PREDICT to place increased scrutiny on shipments from 

facilities where foreign surveillance inspections have been postponed. FDA has made greater 

use of our Foreign Supplier Verification Program (FSVP) regulation to review importer records 

for information showing that foreign suppliers are using processes and procedures consistent 

with FDA Food Safety Modernization Act (FSMA) requirements. The shift to remote FSVP 

inspections, along with other tools utilized by the foods program, was critical to ensuring the 

safety of human and animal food from foreign suppliers during the COVID-19 pandemic. Since 

March 2020, FDA has conducted approximately 3,423 FSVP inspections. Additionally, FDA 

continues to identify human and animal foods that are unsafe, misbranded, or may cause a 

serious health concern for the public at the border with over 15,324 lines being refused 

admission since March 2020.

In July 2020, FDA announced the New Era of Smarter Food Safety Blueprint outlining the 

Agency’s plans over the next decade to create a more digital, traceable, and safer food system. 

The Agency has learned from its response to the pandemic that there is an accelerated need for 

certain goals in this blueprint, especially those involving supply chain continuity and resilience, 

modernized inspectional approaches, strengthening food safety infrastructures with regulatory 

partners, and the safety of foods ordered by consumers online. The number of consumers 

ordering food online has been steadily increasing over the years, but it has skyrocketed during 

the COVID-19 pandemic. Last year, FDA hosted a virtual Summit on E-Commerce, to help the 

Agency improve its understanding of how human and animal foods are sold through e-commerce 
27

models and to identify courses of action for addressing potential food safety vulnerabilities, 

including those that may arise in the “last mile” of delivery.

Imports, Inspections, Compliance and Protecting the Medical Supply Chain 

Similar to their work protecting the food supply, import investigators have been on site 

protecting the medical supply chain at our ports of entry, courier facilities, and the international 

mail facilities (IMFs) throughout the pandemic, with uninterrupted support from ORA 

laboratories. Through continued vigilance, FDA has prevented unsafe and unproven 

pharmaceuticals and other medical products from entering the country. Since March 2020, with 

the cooperation of and in coordination with the U.S. Customs and Border Protection (CBP), FDA 

has refused and destroyed more than 119,000 products, totaling over 21,232,063 capsules, 

tablets, and other dosage forms of violative drugs shipped via international mail.

Since March 2020, FDA has maintained the same level of screening for products offered for 

import as pre-pandemic and refused approximately 160,464 lines violative medical products

offered for import. FDA has focused examinations on COVID-19 relief supplies to ensure that 

reviews of compliant products are expedited while maintaining our commitment to refusing 

medical products that appear to be unsafe, misbranded, unapproved, counterfeit, or may cause 

serious illness or injury to the public. Import investigators have evaluated donations of 

shipments destined for the Federal Emergency Management Agency (FEMA) and have been

instrumental in expediting the importation of vaccines and related shipments and other COVID19 necessities starting with the first vaccines (Pfizer Belgium) shipped into the United States in 

December 2020. 

Despite generally pausing domestic and foreign surveillance inspections in March 2020 to 

safeguard the health and well-being of our staff, as well as employees at facilities we inspect, our 

investigators continued to conduct mission critical inspections both domestically and abroad and 

to do other prioritized domestic inspectional work when possible, to ensure FDA-regulated 

industries were meeting applicable FDA requirements. FDA developed a rating system to assist 

in determining when and where it was safest to conduct prioritized domestic inspections until we 

resumed standard inspectional operations for domestic surveillance inspections in July 2021. 
28

On May 5, 2021, FDA issued a report titled, “Resiliency Roadmap for FDA Inspectional 

Oversight,” 12 outlining the Agency’s inspectional activities during the COVID-19 pandemic and 

its detailed plan to move toward a more consistent state of operations, including FDA’s priorities 

related to this work going forward. The report was updated on November 22, 2021.13

The report described our oversight work during the pandemic and outlined the inspectional 

activities that the Agency had postponed due to travel restrictions or inability to ensure the safety 

of our workforce or the workforces within the industries the Agency regulates. The report also 

outlined the number of mission-critical inspections FDA completed during that time, such as 

inspections of facilities for which there was a drug shortage, inspections needed for the approval 

of novel drugs or drugs related to the potential treatment of COVID-19, support of pre-market 

and pre-license applications, and response to foodborne disease outbreaks or other food safety 

risks such as food contaminated with pathogens. 

Additionally, the Resiliency Roadmap outlines FDA’s continued, successful use of alternative 

tools and approaches where inspections are not feasible, including remote assessments (e.g. 

requests to regulated establishments to remotely view records as well as remote interactive 

evaluations that include remote livestreaming video of operations), teleconferences, or screen 

sharing, and leveraging information from trusted regulatory partners. For example, ORA made 

over 2,100 requests to human and animal drug and biological product manufacturers to remotely 

view records, to support on-time regulatory decision actions. Our review of records requested 

under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act supported more than 350 

approval recommendations for new or abbreviated drug applications, as well as support for 

authorization decisions for EUA requests, potentially allowing new products to come to market 

and provide access to lower cost generic drugs to patients more quickly than may have otherwise 

been possible. 

Notably, FDA’s bioresearch monitoring program staff have conducted more than 200 remote 

assessments that were directly used in application decisions.14 The new tool was incentivized for 

12 https://www.fda.gov/media/148197/download 13 https://www.fda.gov/media/154293/download 14 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/remote-interactive-evaluationsdrug-manufacturing-and-bioresearch-monitoring-facilities-during-covid
29

and supported by industry and continues to provide the Agency with valuable information to 

assist with risk-based targeting for inspections. FDA recognizes that remote approaches do not 

replace inspections, and that there are situations where only an inspection is appropriate, based 

on risk and history of compliance with FDA regulations. 

The Resiliency Roadmap further outlined the ongoing steps the Agency is taking to resume 

standard operational levels of inspection activities, including how it intended to prioritize 

domestic and foreign inspections that could not be performed during the pandemic. FDA began 

to transition back to standard operations for domestic surveillance inspections and other 

prioritized operational work on July 1, 2021, and exceeded the goals that were detailed in the 

May Resiliency Roadmap. We also exceeded our performance goal related to following up on

previous inspections classified as official action indicated (OAI). 

Since October 1, 2021, FDA has been performing domestic inspections at normal operational 

levels and recently began to conduct foreign facility inspections, including surveillance and other 

inspectional work, as well. As FDA works through the inventory of postponed surveillance 

inspections, the Agency is prioritizing higher-risk establishments. For example, a sterile 

manufacturing site that has not been previously inspected and is making narrow therapeutic 

index drugs would likely be deemed a higher risk than a site that had a well-known inspectional 

and compliance history that is making solid oral dosage form drugs. This means that postponed 

inspections will be prioritized based on risk and conducted over a longer period of time, 

ultimately increasing the amount of time between inspections of certain lower-risk facilities in 

order to focus on products that present the greatest risk to public health. 

The Agency launched a multi-year modernization effort in July 2021 to further transform our 

data enterprise platforms and cross-program interoperability infrastructure to better support 

innovation related to its regulatory oversight role. This includes adopting technology to support 

regulatory assessments to improve our remote receipt, review, and analysis of industry data and 

records, and improve remote interactions with industry entities to be easier, more efficient, more 

consistent, and more secure. This modernization effort includes a review of inspectional 

approaches using next-generation assessment technologies and improvements. FDA established 

an Agency-wide Inspectional Affairs Council (FIAC) that provides coordination of inspection 
30

approaches and assessment processes. The Agency intends to share more information on these 

efforts as this work progresses. FDA will continue to leverage and maximize every available 

tool and resource to meet its regulatory oversight responsibilities, while achieving optimal public 

health outcomes.

Compliance and Enforcement 

FDA exercises its regulatory authority by, among other things, issuing warning letters and 

pursuing civil and criminal enforcement actions against firms and individuals who do not comply 

with regulatory requirements, including those distributing unapproved products with false or 

misleading claims that the products prevent, treat, mitigate, diagnose, or cure COVID-19. In 

March 2020, FDA launched Operation Quack Hack, which leverages the Agency’s expertise and 

advanced analytics to protect consumers from fraudulent medical products, including unproven 

treatments, illegitimate test kits, and substandard or counterfeit respirators. FDA has sent 

hundreds of abuse complaints to domain name registrars and internet marketplaces. The Agency 

also has sent 285 warning letters to sellers of unproven products claiming to treat, prevent, or 

cure COVID-19. Working with the Department of Justice (DOJ), FDA has sought and obtained 

preliminary and permanent injunctions that require defendants to halt the sale of unproven 

products claiming to treat or prevent COVID-19, including one product, “Miracle Mineral 

Solution,” that, when used as directed, is equivalent to industrial bleach. In addition, since the 

start of the COVID-19 pandemic, FDA has issued 22 warning letters to owners and/or operators 

of illicit internet pharmacy websites that offer unapproved and misbranded drugs purporting to 

treat COVID-19 for sale to U.S. consumers.

In addition, ORA’s Office of Criminal Investigations (OCI), working with other federal and local 

law enforcement agencies, has conducted criminal investigations involving unproven COVID19-related products. In one such example, OCI investigated a physician who attempted to profit 

from the pandemic by marketing and selling an unproven COVID-19 treatment. The physician 

marketed and sold treatment kits—which included hydroxychloroquine—as a cure for COVID19. In May 2022, the physician was sentenced to 30 days’ imprisonment and one year of home 

confinement after pleading guilty to, among other things, trying to smuggle hydroxychloroquine 

into the United States to sell in his COVID-19 “treatment kits.” In another case, OCI 

investigated an individual who attempted to import approximately 1,000 unlawful COVID-19 
31

test kits from China, which were intercepted at a FedEx facility in Memphis, Tennessee. As a 

result of OCI’s investigation, the individual was fined and sentenced to 36 months of probation 

in October 2021 after pleading to a felony smuggling charge. OCI also has conducted criminal 

investigations to bring to justice those who tamper with COVID-19 vaccines. For example, OCI 

investigated a hospital pharmacist who tampered with COVID-19 vaccine doses at a Wisconsin 

hospital where he worked. On two successive nights, the pharmacist purposefully removed a 

box of COVID-19 vaccine vials from the hospital’s refrigeration unit intending to render the 

vaccines inert and no longer effective. Before the full extent of his conduct was discovered, 57 

people received doses of the vaccine from these vials. In January 2021, the pharmacist pleaded 

guilty to two counts of attempting to tamper with consumer products with reckless disregard for 

the risk that another person will be placed in danger of death or bodily injury. He has been 

sentenced to three years imprisonment, followed by three years of supervised release, and he 

must pay approximately $83,800 in restitution to the hospital.

In addition, FDA investigators remain on the front lines at ports of entry, quickly examining, 

reviewing, and sampling import entries, and refusing admission of violative products where 

appropriate. We protect the supply chain in two equally critical ways: first, we help ensure safe 

products are coming in; and second, we help prevent illegal, dangerous, and fraudulent products 

from getting into the country. These efforts include partnering with U.S. Customs and Border 

Protection (CBP) in establishing satellite laboratories at selected International Mail Facilities 

(IMFs) with scientists using state-of-the-art screening tools to rapidly identify unapproved, 

counterfeit and illicit products.

In March 2020, OCI, with the help of domestic law enforcement partners and foreign 

counterparts in the United Kingdom, led the investigation of fraudulent COVID-19 “treatment 

kits” that were falsely declared as “water treatment.” Import examination of these shipments 

found misbranded “kits” intended to treat COVID-19. As a result of this investigation, a British 

national was sentenced to 10 months of confinement after pleading guilty to shipping mislabeled 

and unapproved products. In May 2020, FDA worked with CBP to intercept several shipments 

of counterfeit facemasks, with the result that they were refused and destroyed before entering 

U.S. commerce.
32

FDA also has taken steps to address hand sanitizer products that pose safety concerns, such as 

products that do not meet the required ethanol or isopropanol levels or that contain or may 

contain toxic ingredients like methanol or 1-propanol. FDA has tested several hundred products 

using field-based and laboratory-based tools and found more than a hundred violative products. 

FDA also has taken steps to help ensure that these dangerous or subpotent products do not enter 

domestic commerce, including coordinating with CBP to identify such products, and we have 

listed products made by more than 70 manufacturers on import alert. FDA also placed all 

alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products 

from entering the U.S. that appear to be in violation until the Agency is able to review the 

products. That action marked the first time the FDA has issued a countrywide import alert for 

any category of drug product. 

In addition to the use of compliance and enforcement tools, FDA also used targeted 

communication to alert the public and address misinformation about the efficacy of products 

purported to treat COVID.

Medical Product Supply Chain 

FDA monitors and responds to worldwide demand and supply chain disruptions for medical 

products caused by the COVID-19 pandemic.15 We work closely with manufacturers, within our 

current resources and authorities, to help ensure they continue to notify the Agency of any 

permanent discontinuance or interruption of drug (human and animal), biological product, and 

device manufacturing in a timely manner, and we are working to better position the Agency and 

our health care system to assure a strong domestic supply chain in future emergencies. 

This is especially important as the COVID-19 pandemic has exposed major vulnerabilities in the 

supply chain that FDA continues to face as it works to help ensure access to the treatments and 

devices that patients and healthcare providers need.

15 https://www.whitehouse.gov/wp-content/uploads/2021/06/100-day-supply-chain-review-report.pdf
33

In addition to our usual communications with drug manufacturers, we work closely with 

healthcare and pharmacy systems, hospitals, providers, and others on the frontlines of COVID19 patient care to identify problems with access to critical care drugs used to treat COVID-19.

FDA understands the significant impact shortages can have on patient care, and we are using our 

authorities to help prevent and alleviate disruptions. When we identify a shortage, we react 

swiftly to help mitigate the impact to U.S. patients and health care professionals, and quickly 

share that information with the public. Restoring and increasing the supply of approved drugs 

has been the Agency’s priority. In addition, where necessary, FDA has issued temporary policies 

during the COVID-19 emergency to respond to reports from hospitals of increased demand and 

interruptions in supply, some of which have not resulted in a drug shortage but caused concern 

about continuing access to drugs to support hospitalized patients with COVID-19. We issued 

temporary policies for outsourcing facilities registered with FDA and pharmacists in statelicensed pharmacies or federal facilities, regarding the compounding of certain drugs used for 

hospitalized patients with COVID-19. The Agency has published guidances to help applicants 

and manufacturers provide FDA with timely and informative notifications about changes in the 

production of certain human drugs, including biological products, and certain animal drugs. We 

urged the timely submission of these notifications, which may assist in our efforts to prevent or 

mitigate shortages of such products. In addition, section 503B(a)(2)(A) of the FD&C Act permits 

outsourcing facilities to use bulk drug substances to compound drug products that appear on the 

drug shortage list in effect under section 506E of the FD&C Act at the time of compounding, 

distribution, and dispensing, when all conditions of section 503B are met.

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act), signed into law on 

March 27, 2020, included authorities intended to enhance FDA’s ability to identify, prevent, and 

mitigate possible drug shortages by, among other things, enhancing FDA’s visibility into drug 

supply chains. The CARES Act expanded the requirement for manufacturers of certain drugs to 

provide information on permanent discontinuances and interruptions in manufacturing that may 

lead to a meaningful disruption in supply to FDA, and required FDA to prioritize and expedite, 

as appropriate, the review of certain applications and inspections that could help mitigate or 

prevent a shortage of a drug covered by section 506C(a) of the FD&C Act.
34

Our experience with COVID-19 only reemphasized that a strong domestic supply chain depends 

on a resilient supply chain for medical devices. Even before the pandemic hit the U.S., there 

were disruptions in the medical device supply chain due to higher demand for devices in other 

nations where COVID-19 was already prevalent and shutdowns in locations from which supplies 

were sourced. As a result, FDA began shortage mitigation activities for medical devices in 

January 2020 before the public health emergency was declared in the U.S., and two months 

before a pandemic was declared worldwide. At that time, the Agency did not have any dedicated 

funding or explicit authority regarding prevention or mitigation of medical device or animal drug 

shortages. The Agency lacked dedicated staff necessary to mitigate supply chain disruptions 

and/or shortages. Nevertheless, the Agency took several actions to rapidly respond to medical 

device supply chain needs, including reassigning over 130 staff to perform shortages work across 

CDRH and contacting over 1,000 manufacturing facilities in 12 countries in just a few weeks’ 

time to get as much information as possible about critical devices. However, because the Agency 

lacked any explicit shortages authority at this time, only about one-third of facilities that were 

contacted responded even in part to CDRH requests because response was voluntary. This lack 

of explicit authority, staff and supply chain information significantly hampered our efforts to 

mitigate and prevent shortages at the outset of the pandemic. 

The CARES Act gave FDA, for the first time, authority related to device shortages (see section 

506J of the FD&C Act). The enactment of the CARES Act at the height of the initial pandemic 

response gave some authority to help prevent or mitigate medical device shortages during the 

public health emergency.16 Throughout COVID, FDA has dealt with hundreds of thousands of 

device units that have been in shortage. FDA used the information it received from its CARES 

Act authorities to prevent or mitigate shortages including diagnostic testing supplies such as 

swabs and viral transport media; blood collection tubes; PPE (respirators, surgical masks, gowns, 

16 Specifically, section 506J of the FD&C Act requires manufacturers to notify FDA of a permanent discontinuance in or 

interruptions in the manufacture of certain devices that are likely to lead to a meaningful disruption in supply of that device in the 

United States during, or in advance of, a public health emergency. Section 506J also requires FDA to maintain a publicly 

available list of devices the Agency has determined to be in shortage, as well as devices that have been discontinued. The Agency 

is also directed to, as it deems appropriate, prioritize and expedite inspections and review of premarket submissions to help

alleviate the supply chain constraint.
35

gloves); ventilators; pediatric trach tubes; dialysis products; infusion pumps and accessories; 

saline flush syringes, sharps containers, needles and syringes.

Specifically, FDA uses the information it receives from the CARES Act to:

• Expedite review of devices and changes to devices;

• Allow/expedite importation;

• Grant enforcement discretion, including outlining flexible approaches for manufacturers 

of certain cleared and approved devices (e.g., remote monitoring systems, ventilators, 

infusion pumps) regarding certain limited modifications made to devices without 

submitting a premarket submission;

• Provide clinical impact assessments to the Assistant Secretary for Preparedness and 

Response (ASPR) and the White House supply chain coordinator to support informed 

decision making regarding shortages;

• Authorize EUAs;

• Communicate with healthcare providers about devices in shortage;

• Inform conservation strategies; and

• Provide assessments that allow for informed decision making on medical device 

shortages across the United States Government.

FDA is using this information to develop shortage assessments that inform potential 

mitigations. This work has helped to protect patients and health care providers 

around the nation from critical shortages of devices.

In addition to the implementation of the new device shortages authorities, FDA has conducted 

horizon scanning to assess demand for devices needed to respond to the pandemic, including 

PPE, ventilators, diagnostic supplies, infusion pumps, and non-contact infrared thermometers; 

and established a rapid response team, working with field personnel to address fraudulent 

imports. The Agency has likewise worked to prevent and mitigate shortages of testing supplies

and other critical medical devices. For example, FDA collaborated with U.S. Cotton, one of the 

world’s largest manufacturers of cotton swabs, to develop and produce a polyester-based swab 

for testing. FDA also collaborated with laboratories and clinical investigators validating 

potential alternative sources of control materials, transport media, and swabs. As individual 

developers validated these alternative components, FDA requested their permission to share their 
36

findings publicly so that others could benefit, and we posted these alternatives on our website. In 

this way, FDA has been serving as a clearinghouse for scientific information that the entire 

community can leverage to mitigate shortages and increase testing capacity. FDA continues to 

post this information on a rolling basis on an FAQ website so that labs have access to the latest 

information regarding alternative controls, transport media, extraction, instruments, and swabs. 

FDA has also worked across the medical device ecosystem to address systemic challenges to our 

supply chain due to sterilization issues and resin shortages. The impacts of supply chain 

disruptions caused by a natural disaster (Texas Winter Storms) have significantly impacted our 

most vulnerable populations. Most recently, devices used to compound total parental nutrition 

for critically ill neonates were impacted by the lack of availability of resins. FDA has worked 

with manufacturers and suppliers to help mitigate this disruption.

FDA continues to work to implement and operationalize the new device shortage authority, as 

well as utilize one time funding from COVID supplementals and $5 million in the first annual

appropriations it received in FY 2022 to stand up a new state-of-the-art Resilient Supply chain 

Program (RSCP). Medical device shortages not only put patients in harm’s way but also 

jeopardize our health care workers on the front lines, during public health emergencies like the 

COVID-19 pandemic and every day in our health care system. Moreover, device shortages 

disproportionately affect at-risk populations and exacerbate health disparities. For these reasons, 

FDA continues to do all it can within its current authorities and resources to mitigate shortages 

and supply chain interruptions for COVID-19 and within the U.S. health care system generally, 

and why the Agency has requested additional authorities and funding in FY 2023 to improve our 

device supply chain readiness going forward 

Congress has acknowledged the importance of FDA’s work on shortages in our health care 

system and we want to continue working with this Committee and others to make sure FDA has 

the resources and authorities needed to ensure U.S. patients and health care providers have the 

medical products they need each day. To ensure the U.S. is properly prepared now and in the 

future, we must take action to secure our medical device supply chain, including related 

materials, parts, and components. FDA recognizes that this will take resources and expanded 

authority. The pandemic has demonstrated that by the time a public health emergency is 
37

declared, it is often too late to effectively prevent or mitigate device shortages. Moreover, there 

are situations that occur frequently that do not rise to the level of a public health emergency –

such as cybersecurity attacks, natural disasters, recalls and spot shortages that may impact one 

region of the country or one particular hospital system, but for which device shortages could 

significantly impact patient care. After the COVID-19 emergency ends, these authorities remain 

tied to a public health emergency – that is, during or in advance of a public health emergency. 

This limits FDA’s ability to identify supply chain vulnerabilities and work with the industry to 

respond to early signs of supply constraints or a potential shortage situation. One need only look 

at the ongoing resin supply chain issue, noted above, to see the wide-spread impacts that have 

lasted for over a year and resulted in shortages of multiple devices to include pediatric trach 

tubes, blood collection tubes, diagnostic tests, and catheters. Most recently, a critical device 

component was impacted by this shortage which resulted in an inability to delivery total parental 

nutrition for neonates 17 Unfortunately, FDA will be very limited in our ability to proactively 

identify and address device shortages after the COVID-19 emergency ends while its device 

shortages authorities remain tied to a public health emergency – that is, during or in advance of a 

public health emergency. 

Conclusion

FDA continues to advance its mission to protect and promote public health by helping to ensure 

the safety of human and animal food, and the safety and effectiveness of medical products. We 

take our public health mandate very seriously and will continue to work each day to help end this 

pandemic. We continue to communicate with the American public and make regulatory 

decisions based on data and sound science. I look forward to continuing to work with the 

Committee on these efforts and thank you again for the opportunity to testify today.

17 https://www.childrenshospitals.org/content/public-policy/letter/critical-shortages-fda-letter