Agents of Bioshield: the Fda, Emergency Use Authorizations, and Public Trust

• Publication year: 2021

Agents of Bioshield: The FDA, Emergency Use Authorizations, and Public Trust

Kirstiana Perryman
University of Georgia School of Law, kap58000@uga.edu

Agents of Bioshield: The FDA, Emergency Use Authorizations, and Public Trust

Cover Page Footnote
J.D. Candidate, 2022, University of Georgia School of Law; B.S., 2015, Emory University. This Note is dedicated to my family and roommates, whose support made completing this Note possible.

AGENTS OF BIOSHIELD: THE FDA, EMERGENCY USE AUTHORIZATIONS, AND PUBLIC TRUST

Kirstiana Perryman^*

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The SARS-CoV-2 pandemic spurred the U.S. Food & Drug Administration (FDA) to utilize the Emergency Use Authorization (EUA) procedure more than ever before. The pandemic pushed the relatively obscure procedure into public consciousness, making it a frequent topic of discussion and debate. The EUA procedure permits the FDA Commissioner to authorize the introduction of drugs, devices, or biological products into interstate commerce for use in an actual or potential emergency. To issue an authorization, the FDA Commissioner must determine that it is "reasonable to believe," based on the "totality of the evidence," that the product "may be effective." This standard creates a lower evidentiary burden than the traditional pathways to market for drugs and vaccines in the United States, allowing the FDA to respond quickly and effectively during public health emergencies (PHEs).

While the flexibility provided by the EUA procedure can and has saved lives, aspects of the procedure can also exacerbate public mistrust in the safety, rigor, and objectivity of FDA review and authorization. Focusing solely on drugs and vaccine EUAs, this Note builds off of existing scholarship to propose three modifications to the EUA procedure: (1) the EUA procedure should mandate that the FDA create and disseminate guidance as soon as practicable after the declaration of a PHE; (2) Congress should modify the evidentiary standard for vaccine EUAs; (3) the EUA procedure should mandate that the FDA cite, in the authorization letter, the evidence it relies upon when deciding to issue an EUA and publicly release any data and studies that underlie its decision. These modifications could yield pragmatic and positive reform without unduly sacrificing the speed and centralized authority the FDA needs to respond effectively to a PHE.

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Table of Contents

I. Introduction....................................................................343

II. Overview of Emergency Use Authorizations...........345

A. THE ENABLING ACTS.................................................345
B. FDA APPROVAL AND LICENSING................................347
C. EMERGENCY USE AUTHORIZATION............................350
D. COMPARISON............................................................353

III. EUAs in Practice..........................................................356

A. ANTHRAX..................................................................356
B. H1N1........................................................................358
C. SARS-COV-2..............................................................360

1. Chloroquine and Hydroxychloroquine.............360
2. Remdesivir........................................................363
3. Convalescent Plasma........................................364
4. Vaccines.............................................................366

IV. Analysis and Possibilities for Reform......................373

A. GUIDANCE................................................................383
B. EUA EVIDENTIARY REQUIREMENTS...........................385
C. TRANSPARENCY........................................................387

V. Conclusion......................................................................388

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I. Introduction

The 2019 coronavirus (COVID-19) pandemic¹ put the U.S. Food and Drug Administration's (FDA) Emergency Use Authorization (EUA) power to the test. During the coronavirus pandemic, the FDA issued more EUAs than ever before,² causing EUAs to become a frequent topic of public discussion and debate.³ The pandemic both highlighted the immense benefits of the EUA power and revealed some of its flaws. The EUA process provides the FDA the essential

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ability to respond quickly to a public health emergency,⁴ but aspects of the process can undermine public trust, confuse health authorities, stymie important data collection efforts, and potentially put individuals at unnecessary risk. These flaws are unlikely to dissipate when the COVID-19 pandemic ends because scientists predict that we will face more outbreaks like COVID-19 in the coming years.⁵

This Note proposes three modifications that would improve the EUA power while retaining its effective elements. First, the EUA procedure should mandate that the FDA create and disseminate guidance as soon as practicable after the declaration of a public health emergency (PHE). Second, Congress should modify the evidentiary standard for vaccine EUAs.⁶ Third, the EUA procedure should mandate that the FDA specifically cite which evidence it relies upon when deciding to issue an EUA and publicly release any data underlying its decision.

Part II of this Note contrasts traditional FDA approval procedures for drugs and vaccines with the EUA procedure.⁷ Part

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III presents an overview of chemical, biological, radiological, or nuclear (CBRN) emergencies during which the FDA has issued EUAs for drugs or vaccines. Part IV first analyzes the benefits and pitfalls of the EUA procedure as applied to drugs and vaccines and then suggests possibilities for reform. Finally, Part V briefly concludes.

II. Overview of Emergency Use Authorizations

This Part describes the EUA procedure through comparison with the traditional pathways for obtaining FDA approval or licensing. This comparison elucidates the unique aspects of the EUA procedure, highlights its potential benefits, and indicates its potential weaknesses.

A. THE ENABLING ACTS

The Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA) grant the FDA the power to approve, license, or authorize drugs and biologics.⁸ Section 505(a) of the FDCA requires that the FDA approve drugs prior to their introduction into interstate commerce, stating that "[n]o person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed . . . is effective with respect to such drug."⁹ Similarly, Section 351 of the PHSA requires that the FDA issue a biologics license prior to a biologic's "introduction into interstate commerce."¹⁰ The statute states that "[n]o person shall introduce or deliver for introduction into interstate commerce any biological product unless . . . a

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biologies license . . . is in effect for the biological product."¹¹ These two statutory sections provide the "traditional new drug approval process[es]," or the "general pathways to market," for drugs and biologics.¹² By contrast, the EUA procedure is a newer and faster pathway to market for drugs and biologics with vastly different requirements.¹³ Section 564 of the FDCA empowers the FDA to issue EUAs for both drugs and biologics, stating that "the Secretary [of Health and Human Services] may authorize the introduction into interstate commerce . . . of a drug, device, or biological product intended for use in an actual or potential emergency (referred to in this section as an 'emergency use')."¹⁴

The most obvious difference between the EUA procedure and the traditional pathways to market is clear from the language of the statutes: the EUA procedure is solely an emergency response,¹⁵ while the traditional pathways have no emergency requirement.¹⁶ An emergency situation drastically alters the FDA's priorities, requiring fast and decisive action.¹⁷ The differences between the processes for obtaining FDA approval or licensing and the process for obtaining an EUA further demonstrate this change in priorities.

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B. FDA APPROVAL AND LICENSING

Under the traditional pathways for approval or licensing, drug developers must first submit an Investigational New Drug (IND) application to the FDA.¹⁸ An IND application requests authorization from the FDA to begin clinical research testing of a drug on humans.¹⁹ The IND must include animal study and toxicity data, manufacturing information, clinical protocols, any data from prior human research, and information about the developer.²⁰ The FDA approves the IND, delays the IND, or prohibits further investigation of the drug or vaccine.²¹ After IND approval, the developer can begin clinical trials.²² Clinical trials usually proceed in four phases, and the FDA requires completion of Phase 3 trials—which typically involve a significantly larger number of study participants than the previous phases—before a developer can apply for approval.²³ Developers typically take several years to complete Phase 1 through Phase 3.²⁴

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After a drug developer has completed Phase 3 clinical trials, the developer can submit a New Drug Application (NDA).²⁵ The NDA includes data gathered through the clinical trials and pre-clinical animal studies.²⁶ The Center for Drug Evaluation and Research (CDER), a division of the FDA, then reviews the NDA.²⁷ To obtain approval for a new drug, a developer must show evidence of safety and effectiveness based on "substantial evidence" derived from well-controlled clinical trials.²⁸ If a developer demonstrates that the drug is "safe and effective for [its] particular intended use, indication, and patient population"²⁹ and that the benefits of the drug outweigh the risks, the FDA will approve the drug.³⁰

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To obtain a biologics license, vaccine developers must submit a Biologics License Application (BLA), which also includes data from pre-clinical trials and clinical trials.³¹ The Center for Biologics Evaluations and Research (CBER), a division of the FDA...