TESTIMONY

OF

ROBERT M. CALIFF, MD

COMMISSIONER OF FOOD AND DRUGS

FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

BEFORE THE

SUBCOMMITTEE ON HEALTH 

AND 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

COMMITTEE ON ENERGY AND COMMERCE 

U.S. HOUSE OF REPRESENTATIVES

THE FEDERAL RESPONSE TO COVID-19 

FEBRUARY 08, 2023 

RELEASE ONLY UPON DELIVERY
Introduction

Chairs McMorris Rodgers, Griffith, and Guthrie, Ranking Members Pallone, Castor, and Eshoo, 

and distinguished members of the Committee, thank you for the opportunity to testify before you 

to discuss the Food and Drug Administration’s (FDA’s or the Agency’s) coronavirus disease 

2019 (COVID-19) response and our preparedness efforts moving forward. 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 facilitate the development, 

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

products to address current and future threats. 

The COVID-19 pandemic underscores the need to continue to optimize our preparedness and 

response capabilities. The Agency’s continued preparedness for, and capabilities to respond to, 

public health emergencies and disease threats such as COVID-19, mpox, respiratory syncytial 

virus and pandemic influenza have been strengthened by Congress’ support of our work. We 

look forward to continuing work with you this Congress to ensure future readiness.

COVID-19 response efforts

This testimony is just a snapshot of the Agency’s extensive work to address this pandemic. 

From the beginning of this public health emergency (PHE), FDA has taken a leadership role in 

the all-of-government response and continues 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, disruptions, and 

contaminated or fraudulent products; and helping to mitigate or prevent such impacts. 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 medical countermeasures to 

fight this virus.

Data show the current vaccines remain highly effective at preventing serious clinical outcomes 

associated with SARS-CoV-2 infection, including hospitalization and death. Staying up to date 

on COVID-19 vaccinations is the best thing Americans can do right now, in addition to other 

precautions, to help protect themselves and their families.
Biologics, Including Vaccines: FDA’s Center for Biologics Evaluation and Research (CBER) 

continues to facilitate the development and availability of vaccines and other biological products 

to combat the COVID-19 pandemic expeditiously and safely. Through our transparent scientific 

evaluation, FDA has issued Emergency Use Authorizations (EUAs) for four monovalent

COVID-19 vaccines: the Pfizer-BioNTech COVID-19 Vaccine for use in individuals six months 

of age and older; the Moderna COVID-19 Vaccine for use in individuals six months of age and 

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

and the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and 

older. FDA has also approved Comirnaty (known as Pfizer-BioNTech COVID-19 Vaccine under 

the EUA) for use in individuals 12 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. 

Additionally, FDA has authorized two COVID-19 vaccines that have a bivalent composition 

(original and Omicron BA.4/BA.5) as a booster dose: Pfizer-BioNTech COVID-19 Vaccine, 

Bivalent; and Moderna COVID-19 Vaccine, Bivalent. Pfizer-BioNTech COVID-19 Vaccine, 

Bivalent was also authorized as a third dose in the 3-dose primary series in individuals six 

months through four years of age. On January 26, 2023, FDA held a meeting of its Vaccines and 

Related Biological Products Advisory Committee (VRBPAC) to consider whether and how the 

composition for primary doses of the currently available COVID-19 vaccines should be modified 

and how and whether the composition and schedule for booster doses should be adjusted moving 

forward. By a unanimous vote, the committee recommended harmonizing the vaccine strain 

composition of primary series and booster doses used in the United States to a single

composition, e.g., the composition for all vaccines administered currently would be a bivalent 

vaccine (Original plus Omicron BA.4/BA.5.).

We have relied on 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. As part of each EUA, manufacturers and vaccination 

providers are required to report certain information, including serious adverse events, even if it is 

unclear whether the vaccine was the cause, including those 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). Vaccine safety is a top priority for the federal government, and we take 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 COVID-19 

vaccines using state-of the art technologies. 

Drug Products: FDA’s Center for Drug Evaluation and Research (CDER) continues its 

successful work to facilitate the development and availability of diverse therapeutics for use by 

patients, physicians, and health systems. 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 to facilitate the development of safe and effective 

products to treat patients with COVID-19. As of January 22, 2023, there are more than 720 drug 

development programs in the planning stages and the Agency has reviewed more than 440 trials 

of potential therapies for COVID-19.1 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 rapidly expands 

our understanding of the effect of different categories of potential treatments. As of January 22, 

2023, FDA has approved three drugs to treat COVID-19 and there are currently fourteen EUAs 

for COVID-19 therapies. 

Medical Devices: FDA’s Center for Devices and Radiological Health (CDRH) has also worked 

to meet the unprecedented demand for medical devices including tests, personal protective 

equipment (PPE), and ventilators, while continuing to fulfill the Center’s mission to protect 

public health and facilitate medical device innovation. 

CDRH staff also utilized vital EUA authorities and interacts frequently with test developers and 

other device manufacturers through the pre-EUA process, including through rolling reviews to 

further expedite emergency use authorization of critical medical devices. This interaction

included working closely with these developers and adapting CDRH’s policies to addressing 

public health needs, as those needs changed. These efforts resulted in increased testing capacity 

and broadened public access to rapid tests, including those purchased over-the-counter (OTC), as

1 https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap 
well as assuring access to other critical devices. CDRH prioritized at-home tests since the 

beginning of the pandemic, authorizing 30 OTC at-home tests, resulting in hundreds of millions 

of additional OTC tests available monthly to American consumers. Since January 2020, FDA has 

engaged with over 1,000 developers and authorized over 443 tests. 

CDRH continues to issue EUAs as appropriate for other types of devices and has taken various 

actions to help facilitate the availability of critical devices and supplies for health care providers 

and patients. To date, we have issued EUAs or provided traditional marketing authorizations to 

over 2,800 medical devices for COVID-19, which is 15 times more EUAs than all other previous 

emergencies combined. In total, CDRH has reviewed 510(k)s for and cleared over 1,900 devices 

that can be used for COVID-19 and certain similar diseases, including future pandemics. CDRH

also issued 28 guidance documents (as well as 21 revisions) outlining policies to help expand the 

availability of medical devices needed in response to COVID-19. 

As we look to transition from the COVID-19 PHE to normal operations, FDA has worked on 

guidances2 for transitioning devices that fall within enforcement policies issued during the 

COVID-19 PHE or that received EUAs to help facilitate a clear and predictable path to market 

for interested developers. FDA intends to facilitate continued access to devices for patients and 

health care providers during the transition and while marketing submissions are under review.

Human and Animal Food: As a key part of FDA’s mission, a safe and accessible food supply is 

critical to the health and well-being of families across the United States. As such, FDA has 

worked with federal, state, local, and industry partners to help ensure a safe and adequate food 

supply for humans and animals. We have seen that the broad supply chain imbalances impacting 

so many products are also impacting food, including infant formula, for which COVID-19 had 

caused supply chain tensions well in advance of the February 2022 recall of certain Abbott infant 

formulas. To help mitigate the shortage, FDA worked to facilitate the importation of millions of

cans of infant formula. Overall, food production and manufacturing in the United States has been 

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

for products impacted in part by pandemic-related issues. 

2 https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrhproposed-guidances-fiscal-year-2023-fy2023 
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 this tool, FDA conducted targeted outreach to the food 

industry to offer additional resources and technical assistance in addressing challenges, including 

monitoring and supporting the infant formula supply chain. 

Imports, Inspections, Compliance and Protecting the Medical Supply Chain: Throughout the 

pandemic, import investigators have been on site protecting the medical supply chain at our ports 

of entry, courier facilities, and the international mail facilities (IMFs), with uninterrupted support 

from the Office of Regulatory Affairs (ORA) laboratories. Through continued vigilance, FDA 

has helped prevent pharmaceuticals and other medical products that do not meet import 

requirements from entering the country. Since March 2020, with the cooperation of and in 

coordination with U.S. Customs and Border Protection, FDA has refused and destroyed more 

than 148,904 drug products, totaling over 28,521,139 capsules, tablets, and other dosage forms 

of violative drugs shipped via international mail. FDA has maintained pre-pandemic levels of 

screening for products offered for import and refused approximately 202,746 medical product 

lines 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 misbranded, unapproved, counterfeit, or otherwise violative. 

Throughout the pandemic ORA continued to conduct mission critical foreign and domestic 

inspection and investigations including those in support of EUAs for critical medical 

countermeasures (MCMs) as well as to ensure the quality and availability of medical products.

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

levels and in April 2022 began to conduct foreign facility inspections, including surveillance and 

other inspectional work. As FDA works through the inventory of postponed surveillance 

inspections, the Agency is prioritizing higher-risk establishments. The ORA inspectorate also 

continues to partner with foreign regulators to conduct inspections and share information to 

increase global access to medical products. 
FDA’s Public Health Emergency Preparedness and Response Mission

The Administration’s National Biodefense Strategy and Implementation Plan on Countering 

Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security 

describes in detail a set of transformative capabilities the U.S. government aims to build to 

defend against future pandemics and biological threats. These include the capability to develop 

and safely deploy medical countermeasures against novel pathogens much more rapidly than is 

possible today. These capabilities will require additional resources and scientific breakthroughs. 

FDA is playing a key role in this effort, to ensure that medical countermeasures can be rapidly 

and rigorously validated to ensure their safety and efficacy for pandemic response. 

The COVID-19 pandemic underscores the importance of a swift and agile response coordinated 

across all levels of government and in collaboration with the private sector. Through effective 

communication, dexterity, and innovation, we were able to mitigate the impact of the pandemic 

and prevent innumerable illnesses and deaths. Preparation for future PHEs depends on utilizing

the many strategies that led to a successful response as well as the establishment and refinement 

of authorities and flexibilities that allow the Agency to identify and mitigate risks while 

promoting innovation. This includes continuing to proactively leverage existing relationships 

with entities outside of FDA in emergency response situations. For example, FDA leveraged an 

ongoing partnership with U.S. veterinary diagnostic laboratories to strengthen COVID-19 testing 

at the height of the COVID-19 pandemic. In ordinary times, this partnership, the Veterinary 

Laboratory Investigation and Response Network (Vet-LIRN), helps the U.S. animal health 

infrastructure rapidly respond to animal health incidents, but during the critical need for COVID19 testing, it successfully increased capacity to accurately test both human and animal samples 

for COVID-19. FDA’s capacity to drive future PHE responses depends on maintaining and 

further building collaborations with regulatory, academic, and industry partners even in the 

absence of a crisis. 

Facilitating Access to Safe and Effective Medical Products

As FDA prepares to combat future pandemics, assuring access to safe and effective medical 

products continues to be of utmost importance. Several areas can provide support in this mission. 
Drug Product Supply Chain

The COVID-19 pandemic served as a reminder that the drug supply chain is extremely 

vulnerable to supply disruptions and surges in demand. Prior to this pandemic, most shortages 

were due to manufacturing issues that disrupted supply, for which manufacturers of drugs and 

active pharmaceutical ingredients (API) are required to notify FDA. This notification 

requirement provides FDA more time to mitigate or prevent a shortage, and the Agency used this 

authority often during the pandemic to prevent supply disruptions. However, during the 

pandemic we also saw unprecedented demand for drugs for which the Agency cannot require 

notifications. 

Looking to future preparedness, and in accordance with the National Strategy for Resilient 

Public Health Supply Chain, it is critical for the U.S. government to have visibility into the endto-end supply chain data access. We believe there are several areas where Congress could build 

on our current authorities to improve our visibility into the supply chain, strengthen our ability to 

oversee the drug supply chain, and ensure continued access to critical drug products. As noted, 

the ability to require drug manufacturers and distributors to report surges in demand to FDA

could help the Agency prevent or mitigate shortages, including their severity and impact on 

patients. Additional improvements in the drug supply chain include:

• Requiring labeling of bulk drug substances to include the original manufacturer and labeling 

of finished drug products to include additional supply chain information to help identify 

sources of APIs, thereby providing greater insight into the supply chain; and

• Enhancing information that manufacturers must report, including the suppliers they relied on 

to manufacture the listed drug and the extent of such reliance, to provide more complete 

supply chain insight. Having this information would allow the Agency to work more 

proactively to diversify the supply chain and reduce the risk of shortages.

Finally, as more manufacturers enter the vaccine and biotherapeutics industries and as we face 

future pandemics, a robust response by ORA’s inspectorate will depend on operational readiness 

and surge capacity. For example, FDA could achieve more effective and efficient oversight 

through enhanced authorities for conducting remote regulatory assessments. This could include 
explicitly extending the ability to request records or other information, in advance of or in lieu of 

inspections, to all FDA-regulated products, as well as authorizing mandatory remote interactive 

evaluations. Congress recognized these authorities were key to future preparedness in the fiscal 

year (FY) 2023 Omnibus by expanding FDA’s authority to request records and other 

information, in advance of or in lieu of an inspection, to devices and to sites or facilities subject 

to bioresearch monitoring inspections. However, the Agency could achieve even greater 

regulatory compliance if this records request authority were expressly extended to all FDAregulated products. Critical investments in this space also include increasing the inspectorate’s 

workforce capacity for oversight of medical products and funding training and continuing 

education of the inspectorate’s workforce. 

Medical Device Supply Chain and Safety

Shortages: In the COVID-19 pandemic, CDRH has worked with manufacturers, health care 

providers, suppliers and our U.S. government partners to mitigate over 350 reported medical 

device shortages, which equates to thousands of medical devices. Using the new device 

shortages authority we received through the CARES Act, we were able to facilitate device 

availability for patients across the United States. This is a vital authority, as our most vulnerable 

populations are those most often impacted the greatest by critical device shortages. 

Based on our experience with this pandemic, as well as with shortages and supply chain 

disruptions that occur outside a PHE, we believe the public health would benefit from removing 

the temporal limitation in statute that only requires manufacturers to notify FDA about 

interruptions or discontinuances in the manufacture of certain devices during or in advance of a 

PHE. The FY2023 Consolidated Appropriations Act (FY23 Omnibus) added voluntary 

notifications from manufacturers about certain device discontinuances or disruptions, but an 

effective device supply chain program requires a more comprehensive and consistent flow of 

information between manufacturers and FDA, similar to what is required for drug products. 

Without this, the Agency remains limited in its ability to collect information that can mitigate or 

prevent medical device shortages, protecting U.S. patients and health care providers. 

Critical shortages occur in many situations that are outside of or unrelated to PHEs, including 

natural or human-made disasters, recalls, geopolitical conflict and production shutdowns, and 
cybersecurity incidents, among other triggering events for which device shortages can still 

significantly impact patient care. Furthermore, by the time there is an emergency, it is often too 

late to mitigate or prevent shortages. For example, supply chain disruptions began even before 

COVID-19 cases were identified in the United States, as other nations had outbreaks and needed 

PPE, testing supplies, and other equipment in excess of supply. 

Another important aspect of supply chain preparedness are risk management plans. The ability to 

require a risk management plan for critical devices would help ensure manufacturers have plans 

in place to ensure resiliency and mitigate future supply chain disruptions. COVID-19 showed us 

that manufacturers are not always prepared for situations where their ability to manufacture 

product may be disrupted or may be insufficient to meet increases in demand, especially where 

they are dependent on one source for a critical raw material or component that was in shortage. 

Risk management planning that occurs even outside of an emergency will result in greater 

resiliency in the critical device supply chain. 

In Vitro Diagnostics: The past few years have also highlighted the critical need for a modernized 

regulatory framework that applies to all in vitro diagnostics. The COVID-19 pandemic 

underscored the importance of both test access and test accuracy. Beyond COVID-19, tests are 

used for many different purposes and are based on many different types of technologies, and they 

are becoming increasingly important to our entire health care system. According to CDC, 70 

percent of health care decisions are based on clinical lab test results.3 Some of those tests are the 

sole determinant of a patient’s treatment. A modern oversight framework that is specifically 

tailored to assuring tests work is critical to position ourselves for the future – whether it is to 

prepare for the next pandemic or to realize the full potential of diagnostic innovation. 

Such a system can balance innovation with assurance of accuracy and reliability for tests. For 

example, a technology certification approach could provide assurances for most tests without 

individual FDA review of the tests. These assurances are critical. We have seen many examples 

of tests that do not work – from COVID-19 tests marketed during the pandemic, to tests that are 

the sole determinant of which treatment a cancer patient receives. In particular, we are concerned 

3 https://www.cdc.gov/csels/dls/strengthening-clinical-labs.html#print 
that there may be inaccurate laboratory developed tests, or LDTs, in use today.4

 This puts patient 

health at risk, undermines our health care system, and hinders the country’s ability to effectively 

address PHEs. 

We look forward to continuing our work with Congress and stakeholders to create a modern 

framework for all tests and to strengthen supply chain authorities. In the meantime, we intend to 

move forward using our current regulatory authorities to offer providers and patients confidence 

in the diagnostic tests that they use.

Overseeing Products Critical to Public Health and Fostering Medical Countermeasure

Development

We have also seen that during a PHE or a supply disruption that other critical products can have 

immense impact on families, as we saw in the infant formula shortage. Preventing food shortages

is critical to public health and we are grateful that Congress included a provision in the FY23 

Omnibus to require manufacturers of infant formulas and certain medical foods to notify FDA of 

potential shortages. Looking forward, parallel authority to require notifications of anticipated 

interruptions in the supply chain of additional categories of foods designated by FDA during a 

declared PHE could help prevent future shortages in the food supply. 

Further, enhancing FDA’s regulatory capabilities and readiness to respond to emerging 

pathogens, ensure blood safety and availability, and expeditiously review new vaccines, existing 

vaccines and other medical products, is vital to the Agency’s continued success in PHE

preparation and response. Our staff have had to be pulled off other work and have been working 

relentlessly on pandemic issues for the past three years, leading to a significant backlog and 

fatigue. During COVID-19 we have seen that FDA staff need to be prepared to continue to 

address the current pandemic needs while also preparing for potential future pandemics and 

staying on top of our daily work to ensure blood safety and availability and regulate vaccines and 

other medical products. Through the creation of a specialized program within CBER to defend 

against emerging pathogens, the Agency would be well positioned to respond to identified 

4 For example, see: Case studies of 20 LDTs that may have caused patient harm (http://wayback.archiveit.org/7993/20171114205911/https:/www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm472773.htm) and FDA’s 

analysis of 125 EUA requests for COVID-19 tests from labs that found 66 percent were not designed or validated appropriately

(https://www.nejm.org/doi/full/10.1056/NEJMp2023830). 
threats of concern and focus experienced resources to work quickly on MCM development to 

address these concerns. In consultation with HHS partners, the program could: provide 

recommendations and guidance to developers of vaccines and other medical products and 

relevant federal partners; use real-world data or real-world evidence to study the safety and 

effectiveness of products for addressing biological incidents and identify which products may be 

best suited for specific pathogens or for use in different populations; and facilitate product 

development including advances in manufacturing. It could also support scientific research 

within CBER that contributes to development and review of biological products to counter 

biological incidents and emerging pathogens.

FDA’s ability to monitor the safety of vaccines would also benefit greatly by a coordinated 

federal public health data reporting authority. Through the Biologics Effectiveness and Safety 

(BEST) Initiative, part of the FDA Sentinel Initiative, FDA can analyze information occurring in 

millions of health insurance claim submissions or electronic health records (EHR) recorded in 

large data systems. FDA’s contractors assist with this program and analyze the data itself behind 

their firewall as part of data privacy protections. While the BEST Initiative has been essential 

for our work and provided us with a robust picture of safety data, our ability to analyze claims 

information is limited by the fact that some vaccinations are not recorded in health insurance 

claims data. Further, when insurance claims databases or EHRs detect an adverse event, FDA 

often needs to quickly verify information or access additional information to evaluate the adverse 

events of interest. When we request records to verify adverse events detected by the BEST 

Initiative databases it has taken FDA around 8-12 weeks in some cases to receive voluntary 

access to these records. Additionally, coordinated federal public health data reporting authority 

would help the Agency to more swiftly identify adverse event patterns and trends associated with 

the use of vaccines or other MCMs, and swiftly be able to communicate with health care 

providers and patients about safety signals. 

Finally, across all these areas, FDA’s partnerships with state, local, and U.S. territorial 

governments continue to play an important role in the protection of public health, particularly as 

FDA partners with them in the regulation of products, helping to ensure the safety and integrity 

of supply chains, and assisting in enforcement against products that are being unlawfully sold. 

Allowing for disclosure of non-public information to these agencies with complementary 
functions related to FDA-regulated products could achieve faster and more effective action to 

protect the public health during national public health emergencies, other state/local disaster 

declarations, outbreaks or other public health events, and for routine regulatory oversight. 

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 in the 

COVID-19 pandemic. The Agency is continuing to monitor its policies, the marketplace, and 

national needs, and will continue to adapt as the circumstances of the pandemic evolve. We take 

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

pandemic and prepare for the next one. We look forward to continuing to work with the 

Committee on the Agency’s public health emergency preparedness and response mission and 

strengthening FDA’s authorities to continue building a resilient supply chain for critical medical 

products, foods, and medical countermeasures. Thank you again for the opportunity to testify.