By Anne Kapnick
The Food and Drug Administration (FDA) is responsible for protecting public health by regulating the production, distribution, and consumption of food, cosmetics and drugs.[1] In the healthcare arena (the focus of this post), the FDA strives to ensure the safety, efficacy, and security of drugs, biological products, and medical devices.[2] The FDA also ensures that the “public get[s] the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”[3] This blog post provides an overview of the FDA’s emergency authorization powers, analyzes the extent of their usage in the COVID-19 pandemic, and concludes by flagging potential concerns regarding the FDA’s management of this vast power.
Under normal circumstances, the FDA medical product approval process is rigorous and requires a high level of scrutiny. However, in times of emergency, like a nationwide pandemic, the FDA has certain tools it can use to make important medical countermeasures available quicker. One such tool is the Emergency Use Authorization (EUA) authority. Under § 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA commissioner is allowed to temporarily authorize unapproved medical products or unapproved uses of approved medical products during certain types of emergencies—such expedited approval methods are known as an EUA. [4]
The FD&C Act §564 has three requirements for issuing an EUA: (1) the determination that an emergency exists by one of three specified cabinet members[5]; (2) the declaration of an emergency justifying the authorization of an EUA by the secretary of Health and Human Services (HHS)[6]; and (3) a finding by the FDA that specified statutory criteria have been met for the medical product in question. The third requirement, the FDA’s specified criteria, requires evaluating these products based on the best available evidence, weighing associated risks against potential benefits. For example, the FDA must conclude that it is reasonable to believe the product may be effective, that the known benefits outweigh the known risks, and that there is no adequate, approved, and available alternative.[7] Once an EUA is issued, it can be amended and may be revoked if the criteria for issuance are no longer met or if revocation is appropriate to protect public health or safety.[8] An EUA does not equate to FDA approval.
The FDA was quick to activate its emergency use powers for managing the COVID-19 pandemic.[9] On February 4, 2020, the HHS Secretary determined, pursuant to § 564, that COVID-19 is a public health emergency that “has a significant potential to affect national security or the health and security of United States citizens living abroad.”[10] On the basis of this determination, the Secretary subsequently declared that “circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 (February 4, 2020), personal respiratory protective devices (March 2, 2020), and other medical devices, including alternative products used as medical devices (March 24, 2020).”[11]
According to the FDA’s website, in response to the COVID-19 pandemic it has issued EUAs for an entire range of medical countermeasures including for: (1) in vitro diagnostic products, (2) personal protective equipment and related devices, (3) ventilators and other medical devices, and (4) drug and biological products. As of October 21, 2020, the FDA has 337 active COVID-19 related EUAs, comprised of:
- 284 active EUAs for in vitro diagnostic products (this includes diagnostic and serology/antibody tests);[12]
- 22 active EUAs for personal protective equipment and related devices;[13]
- 26 active EUAs for ventilators and other medical devices;[14] and
- 5 active EUAs for drug and biological products.[15]
In addition, there are at least 6 EUAs which have been revoked since the beginning of the pandemic.[16]
The scope and magnitude of the FDA’s use of its emergency authorization power during the COVID-19 pandemic is massive when compared with past emergencies. Based on data from the FDA’s website, the FDA issued only 38 EUAs during the Zika, Ebola, MERS, and Avian Flu emergencies combined. The below table summarizes the data:
| Emergency | Current EUAs | Terminated or Revoked EUAs | Total EUAs |
| Coronavirus Disease 2019 (COVID-19) | 337 (284 diagnostic) | 6 (3 diagnostic) | 344 |
| Zika Virus | 14 (14 diagnostic)[17] | 6 (6 diagnostic) | 20 |
| Ebola Virus | 10 (10 diagnostic)[18] | 3 (3 diagnostic)[19] | 13 |
| Middle East Respiratory Syndrome Coronavirus (MERS-CoV) | 2 (2 diagnostic)[20] | 0[21] | 2 |
| Avian Influenza (H7N9) | 3 (3 diagnostic) | 0 | 3 |
So far during the COVID-19 pandemic, the FDA has issued nearly 10x the number of EUAs issued in previous emergencies. As is evident from the above data, the vast majority (85%) of the EUAs issued during the COVID-19 pandemic concern diagnostic products. All of EUAs issued in prior emergencies were categorized as diagnostic products. This makes sense intuitively because the process for FDA approval of diagnostics is less rigorous than for therapeutics given the relative risks.
Given the unique nature of the virus that causes COVID-19, experts agree that rapid detection and widespread testing capabilities are necessary to control the spread of the pandemic. Because testing is such an integral countermeasure for controlling this virus, the FDA has focused extensively on “accelerat[ing] the availability of novel coronavirus (COVID-19) tests developed by laboratories and commercial manufacturers for the duration of the public health emergency.”[22] However, the sheer scale of the FDA’s emergency use powers should give us pause—especially when most of these tests are manufactured by profit-seeking corporations who have the financial incentive to push products out ahead of their competitors through the EUA process, before full reliability can be established.
Take, for example, Chembio Diagnostic Systems, Inc.’s DPP COVID-19 IgM/IgG System, which received emergency authorization on April 14, 2020 to detect IgM and IgG antibodies against SARS-CoV-2 (the virus which causes COVID-19) in blood specimens.[23] Chembio’s antigen diagnostic test sat on the market for three months before the FDA revoked its EUA on the grounds that “its performance may be both inconsistent and lower than that described in the request for Authorization.”[24] Chembio was one of the first companies to receive an EUA for an antibody test during the COVID-19 pandemic. The FDA noted that after analyzing subsequent data disclosure from the company and independent researchers, there were performance concerns about the accuracy of the test because it generated a higher than expected rate of false results.[25] The revocation letter further notes that “the risk to public health from the false test results makes EUA revocation appropriate to protect the public health or safety.”[26] Chembio Diagnostics Inc. is a public company. Its stock price rose from $4.70 on March 2, to a year-to-date peak of $15.54 on April 24 (following its EUA approval), before dropping to $3.89 on June 17 following the FDA’s revocation.[27] The stock price reflects the real value the EUA had in the market.
There are, of course, safeguards in the FDA emergency use process for in vitro diagnostic products. The FDA issued guidance outlining its policies for EUA diagnostic tests in February, and has revised this policy three times.[28] These policies help serve as a regulatory roadmap for manufacturers and assist in streamlining the EUA process.[29] One interesting case study is the FDA’s changed guidance on antibody testing. Before issuing the revised guidance, the FDA had released a letter warning to healthcare providers noting the limitations of antibody testing and why those tests results should not be used as the sole basis to diagnose COVID-19. As part of the revised policies, the FDA “provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.”[30] The FDA noted that as the pandemic progressed, the FDA had improved it understanding of the performance and expectations required for COVID-19 serology (antibody) tests, and that while a higher level of flexibility may have been appropriate in March, they now had sufficient understanding of antibody test performance and could set higher and more definitive standards.[31] At the time the FDA issued its revised guidance, 12 antibody tests had been authorized under individual EUAs.[32] The FDA subsequently revoked 2 (or 17%) of those tests on the grounds that they were now considered ineffective under the new guidelines.[33]
At the beginning of this pandemic, the FDA was faced with an urgent need to diagnose and treat individuals in order to prevent the spread of COVID-19. Section 564 of the FD&C Act provides the FDA with much needed flexibility in order to promote timely access to critical medical products. The impetus of the EUA power is that in extraordinary circumstances, we cannot always afford to wait for all the evidence to emerge. The FDA has also demonstrated that it is willing to adapt as it learns new information, but there are future questions and implications to explore once this pandemic is controlled. Most importantly, will the FDA’s extensive use and revision of emergency authorizations erode or undermine trust in FDA processes in the future? How rigorous should the continued review process be following an EUA, and who should bear that burden—the FDA, the company, or independent researchers? Are the current controls sufficient to safeguard consumer welfare and confidence? Does the consumer have enough information to make an informed decision about their testing options? Do we fully understand the risk of inaccurate diagnostic devices on public health? And finally, should there be greater hurdles for emergency authorization of diagnostic devices?
[1] See What We Do, U.S. Food and Drug Administration, https://www.fda.gov/about-fda/what-we-do (last visited Oct. 21, 2020).
[2] Id.
[3] Id.
[4] See Emergency Use Authorization, U.S. Food and Drug Administration, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization (last visited Oct. 21, 2020).
[5] This determination can be made by the secretaries of the Department of Homeland Security, the Department of Defense, or the Department of Health and Human Services. See Food, Drug, and Cosmetics Act § 564(b), 21 U.S.C. § 360bbb–3(b).
[6] Note that the §564 declaration of emergency is different from a determination of public health emergency under PHS Act §319 and a declaration of a public health emergency under the PREP Act.
[7] See Food, Drug, and Cosmetics Act § 564(c), 21 U.S.C § 360bbb–3(c).
[8] Id.
[9] The first U.S. cases of nontravel–related COVID-19 were confirmed on February 26 and 28, 2020. See CDC Confirms Possible Instance of Community Spread of COVID-19 in U.S., Centers for Disease Control and Prevention (Feb. 26, 2020), https://www.cdc.gov/mmwr/volumes/69/wr/mm6922e1.htm.
[10] See Emergency Use Authorization, U.S. Food and Drug Administration, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization (last visited Oct. 21, 2020).
[11] https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices
[12] See Emergency Use Authorization, U.S. Food and Drug Administration, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization (last visited Oct. 21, 2020).
[13] Id.
[14] Id.
[15] Id.
[16] See Emergency Use Authorization–Archived Information, U.S. Food and Drug5 Administration, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information#covid19 (last visited Oct. 21, 2020).
[17] See Emergency Use Authorization, U.S. Food and Drug Administration, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization (last visited Oct. 21, 2020).
[18]Id.
[19] See Emergency Use Authorization–Archived Information, U.S. Food and Drug Administration, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information#covid19 (last visited Oct. 21, 2020).
[20] See Emergency Use Authorization, U.S. Food and Drug Administration, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization (last visited Oct. 21, 2020).
[21] While 2 EUAs expired, they have been reissued, and thus have current counterparts. See Emergency Use Authorization–Archived Information, U.S. Food and Drug Administration, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information#covid19 (last visited Oct. 21, 2020).
[22] See Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised), U.S. Food and Drug Administration (May 11, 2020), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised.
[23] Id.
[24] Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Antibodies Against SARS-CoV-2, the Virus That Causes Coronavirus Disease 2019 (COVID-19), U.S. Food and Drug Administration (July 14, 2020), https://www.federalregister.gov/documents/2020/07/14/2020-15138/revocation-of-authorization-of-emergency-use-of-an-in-vitro-diagnostic-device-for-detection-of.
[25] See id.
[26] Id.
[27] Chembio Diagnostics, Inc. (CEMI), yahoo! Finance, https://finance.yahoo.com/quote/CEMI/.
[28] See Emergency Use Authorization, U.S. Food and Drug Administration, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization (last visited Oct. 21, 2020).
[29] See Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised), U.S. Food and Drug Administration (May 11, 2020), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised.
[30] Anand Shah and Jeff Shuren, Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy, U.S. Food and Drug Administration (May 4, 2020), https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-and-accuracy.
[31] See id.
[32] See id.
[33] See Emergency Use Authorization–Archived Information, U.S. Food and Drug Administration, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information#covid19 (last visited Oct. 21, 2020).
This post was originally published on the COVID-19 and the Law blog.
Annie Kapnick graduated from Harvard Law School in May 2021.
