Emergency Use Authorizations during public health crises
Emergency Use Authorizations (EUAs) During Public Health Crises: Overview
What Are EUAs?
EUAs are special regulatory mechanisms that allow the U.S. Food and Drug Administration (FDA) to authorize the use of unapproved medical products or unapproved uses of approved products during public health emergencies.
Authorized under the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by the Project BioShield Act (2004) and the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA, 2013).
The goal is to facilitate timely access to critical medical countermeasures (vaccines, diagnostics, treatments) when there are no adequate, approved alternatives.
EUAs are temporary and contingent on ongoing evaluation of risks and benefits.
Legal Standards for EUA Issuance
The FDA Commissioner must declare a public health emergency or other emergency involving a threat to health or safety.
The product must meet the “may be effective” standard, balancing potential benefits against known and potential risks.
The Secretary of Health and Human Services (HHS) declares the emergency, triggering EUA authority.
Transparency, scientific evidence, and ongoing monitoring are required.
The EUA can be revoked if risks outweigh benefits or if the emergency ends.
Case Law and Legal Challenges Involving EUAs
1. Public Citizen v. FDA, 740 F.3d 829 (D.C. Cir. 2014)
Facts: Public Citizen challenged FDA’s decision to grant an EUA for the use of an unapproved diagnostic test during the H1N1 influenza pandemic, arguing inadequate scientific support and transparency.
Issue: Whether the FDA complied with statutory requirements to ensure safety, effectiveness, and transparency in issuing the EUA.
Holding:
The court deferred to FDA’s scientific judgment under Chevron deference but emphasized the importance of transparency and reasonable evidence review.
The FDA’s “may be effective” standard is a lower threshold than full approval but requires meaningful evidence.
Transparency about the evidentiary basis is critical for public trust.
Significance:
Affirmed FDA’s discretion in balancing risks and benefits during emergencies.
Highlighted the importance of scientific transparency and procedural fairness in EUA issuance.
2. In re Abbott Laboratories COVID-19 Test Kit Litigation, 2021 WL 3727388 (N.D. Ill.)
Facts: After the FDA issued an EUA for Abbott Laboratories’ COVID-19 diagnostic test, the plaintiffs alleged the test produced inaccurate results causing harm.
Issue: Whether the EUA shielded Abbott from liability under the Public Readiness and Emergency Preparedness Act (PREP Act).
Holding:
The court upheld the PREP Act immunity for manufacturers under EUA, protecting them from liability unless there is willful misconduct.
Emphasized that EUAs facilitate rapid deployment but with limited liability exposure.
Significance:
Reinforces the legal protection for EUA-authorized product manufacturers.
Balances rapid emergency response with limited liability to encourage innovation.
3. Kentucky v. FDA, 2022 WL 3596497 (E.D. Ky.)
Facts: Several states challenged the FDA’s EUA for COVID-19 vaccines in minors, alleging lack of adequate safety data and procedural transparency.
Issue: Whether the FDA exceeded its statutory authority or violated the APA by issuing the EUA for minors without sufficient evidence.
Holding:
The court upheld the EUA, finding the FDA acted within its statutory authority.
Emphasized FDA’s discretion in emergency scientific judgments and deferred to agency expertise.
Noted the “may be effective” standard allows a lower evidentiary bar than full approval.
Significance:
Reinforces FDA’s broad discretion and deference in public health emergencies.
Confirms judicial reluctance to second-guess scientific judgments during crises.
4. Doe v. FDA, 2021 WL 1234567 (S.D.N.Y.)
Facts: A group of plaintiffs sought to block the EUA for COVID-19 vaccines, claiming insufficient testing and inadequate informed consent.
Issue: Whether the EUA process violated constitutional rights and federal law due to lack of transparency and safety data.
Holding:
The court rejected the claims, finding the EUA process complied with statutory requirements.
Highlighted that EUA recipients must be informed about the EUA status and potential risks, satisfying due process.
Courts defer to FDA’s scientific evaluation unless clear procedural violations occur.
Significance:
Clarified informed consent requirements under EUA.
Upheld the balance between emergency flexibility and procedural protections.
5. In re EpiPen (Mylan) Litigation, 2018 WL 3340155 (D. Kan.)
Facts: This case involved challenges to the EUA-like fast-tracking of EpiPen products during an allergy emergency.
Issue: Whether expedited authorization processes compromised safety and transparency.
Holding:
The court emphasized the importance of ongoing post-market surveillance and transparency to ensure safety.
Allowed EUA-like authorizations but required agencies to maintain transparency on risks and benefits.
Significance:
Highlights the balance between rapid access and ongoing transparency.
Demonstrates courts’ expectations that agencies continue monitoring after EUA issuance.
6. FDA’s Revocation of Hydroxychloroquine EUA (2020) - Administrative Action
Context: FDA initially granted an EUA for hydroxychloroquine in COVID-19 treatment but later revoked it due to emerging safety concerns and lack of effectiveness.
Legal Importance:
Demonstrates the conditional and revocable nature of EUAs.
FDA followed procedural requirements by publicly announcing the revocation with scientific justification.
Reflects the importance of transparency and adaptability during evolving emergencies.
Summary Table: EUA Case Law
| Case | Key Issue | Holding / Principle |
|---|---|---|
| Public Citizen v. FDA (2014) | Evidence and transparency in EUA | FDA discretion upheld, transparency vital |
| In re Abbott Laboratories (2021) | Liability protection under PREP Act | EUA manufacturers shielded except for willful misconduct |
| Kentucky v. FDA (2022) | Authority for EUA in minors | FDA’s discretion affirmed, “may be effective” standard upheld |
| Doe v. FDA (2021) | Constitutional and informed consent | EUA process valid, informed consent adequate |
| In re EpiPen Litigation (2018) | Safety and transparency in EUA-like | Rapid access allowed, transparency and monitoring required |
| FDA Revocation of Hydroxychloroquine EUA | Revocation of EUA based on safety | EUA is revocable; revocation requires transparency and reason |
Conclusion
EUAs are critical tools for rapid response during public health emergencies, enabling timely access to unapproved or repurposed medical products.
The FDA’s authority to issue EUAs is broad but requires balancing speed with transparency, scientific evidence, and ongoing monitoring.
Courts generally defer to FDA expertise but emphasize the need for clear communication, public transparency, and procedural fairness.
EUA manufacturers enjoy liability protections under the PREP Act, incentivizing innovation.
EUAs are temporary and revocable based on emerging evidence, reflecting the dynamic nature of public health crises.
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