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Drug Development

Missed Opportunities on Emergency Remdesivir Use

Educational Objective
To understand the missed opportunities that occurred with the Federal Governments EUA for Remdesivir usage

1 Credit CME

JAMA

Published Online: June 24, 2020

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Article Information and Disclosures

Ameet Sarpatwari, PhD, JD¹;

Anna Kaltenboeck, MA²;

Aaron S. Kesselheim, MD, JD, MPH¹

Author Affiliations

¹Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
²Drug Pricing Lab, Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center, New York, New York

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Emergency Use Authorization of Remdesivir

Michael G. Ison, MD, MS; Cameron Wolfe, MBBS, MPH; Helen W. Boucher, MD
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A Proposed Lottery System to Allocate Scarce COVID-19 Medications

Douglas B. White, MD, MAS; Derek C. Angus, MD, MPH
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Need for Transparency and Reliable Evidence in Emergency Use Authorizations for COVID-19 Therapies

Mike Z. Zhai, BA; Carolyn T. Lye, BA; Aaron S. Kesselheim, MD, JD, MPH
Original Investigation

Effect of Remdesivir vs Standard Care on Clinical Status of Patients With Moderate COVID-19

Christoph D. Spinner, MD; Robert L. Gottlieb, MD, PhD; Gerard J. Criner, MD; José Ramón Arribas López, MD; Anna Maria Cattelan, MD; Alex Soriano Viladomiu, MD; Onyema Ogbuagu, MD; Prashant Malhotra, MD; Kathleen M. Mullane, DO; Antonella Castagna, MD; Louis Yi Ann Chai, MD; Meta Roestenberg, MD; Owen Tak Yin Tsang, MD; Enos Bernasconi, MD; Paul Le Turnier, MD; Shan-Chwen Chang, MD; Devi SenGupta, MD; Robert H. Hyland, DPhil; Anu O. Osinusi, MD; Huyen Cao, MD; Christiana Blair, MS; Hongyuan Wang, PhD; Anuj Gaggar, MD, PhD; Diana M. Brainard, MD; Mark J. McPhail, MD; Sanjay Bhagani, MD; Mi Young Ahn, MD; Arun J. Sanyal, MD; Gregory Huhn, MD; Francisco M. Marty, MD; for the GS-US-540-5774 Investigators
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Emergency Use Authorizations During the COVID-19 Pandemic—Lessons From Hydroxychloroquine for Upcoming Vaccine Approval

Kyle Thomson, JD, MPH; Herschel Nachlis, PhD

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On May 1, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for remdesivir for the treatment of hospitalized adults and children with severe coronavirus disease 2019 (COVID-19). An EUA permits the use of an unapproved drug, biologic, or medical device and may be issued by the FDA when the secretary of Health and Human Services has declared a public health emergency “that has a significant potential to affect national security or the health and security of United States citizens living abroad.”¹ As seen with the FDA’s recent revocation of the EUA for hydroxychloroquine, the agency has wide discretion to revoke or revise EUAs when appropriate for public health (the FDA does not have comparable authority to act so quickly with respect to drugs that have been approved).

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Article Information

Corresponding Author: Ameet Sarpatwari, PhD, JD, Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, 1620 Tremont St, Ste 3030, Boston, MA 02120 (asarpatwari@bwh.harvard.edu).

Published Online: June 24, 2020. doi:10.1001/jama.2020.11932

Conflict of Interest Disclosures: Ms Kaltenboeck reported receiving personal fees from AstraZeneca and SVB Leerink, a grant from Kaiser Permanente outside the submitted work, and serving on the Advisory Committee for the ICER report on drug price increases without supporting clinical evidence. No other disclosures were reported.

Funding/Support: Dr Sarpatwari and Dr Kesselheim’s work was supported by Arnold Ventures and the Harvard-MIT Center for Regulatory Science. Ms Kaltenboeck’s work was supported by Arnold Ventures.

Role of the Funder/Sponsor: Arnold Ventures and the Harvard-MIT Center for Regulatory Science had no role in the preparation, review, or approval of the manuscript or decision to submit the manuscript for publication.

Additional Contributions: We thank Jerry Avorn, MD (PORTAL), and Patricia J. Zettler, JD (The Ohio State University Moritz College of Law), for their comments on an earlier draft.

References

Federal Food, Drug, and Cosmetic Act, §360bbb-3: Authorization for medical products for use in emergencies, 21 USC §360bbb–3 (2011).

Ison MG , Wolfe C , Boucher HW . Emergency use authorization of remdesivir: the need for a transparent distribution process. JAMA. 2020;323(23):2365-2366. doi:10.1001/jama.2020.8863 PubMed Google Scholar

Beigel JH , Tomashek KM , Dodd LE , et al; ACTT-1 Study Group Members. Remdesivir for the treatment of Covid-19—preliminary report. N Engl J Med. Published online May 22, 2020. doi:10.1056/NEJMoa2007764 PubMed Google Scholar

Wang Y , Zhang D , Du G , et al. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2020;395(10236):1569-1578. doi:10.1016/S0140-6736(20)31022-9 PubMed Google Scholar Crossref

Langreth R. Gilead falls as drug has only small benefit in large trial. Bloomberg News. Updated June 1, 2020. Accessed June 18, 2020. https://www.bloomberg.com/news/articles/2020-06-01/gilead-drug-has-only-modest-benefit-in-large-trial-shares-fall

Institute for Clinical and Economic Review. Alternative pricing models for remdesivir and other potential treatment for COVID-19. Updated May 1, 2020. Accessed June 18, 2020. https://icer-review.org/wp-content/uploads/2020/05/ICER-COVID_Initial_Abstract_05012020-3.pdf

Sarpatwari A , Curfman G . Mitigating health risks of prescription drugs: lessons from FDA oversight of opioid products. JAMA. 2019;321(7):651-653. doi:10.1001/jama.2019.0236 PubMed Google Scholar Crossref

White DB , Angus DC . A proposed lottery system to allocate scarce COVID-19 medications: promoting fairness and generating knowledge. JAMA. Published online June 24, 2020. doi:10.1001/jama.2020.11464 Google Scholar

Garg S , Kim L , Whitaker M , et al. Hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease 2019—COVID-NET, 14 States, March 1–30, 2020. MMWR Morb Mortal Wkly Rep. 2020;69(15):458-464. doi:10.15585/mmwr.mm6915e3 PubMed Google Scholar Crossref

Eastman RT , Roth JS , Brimacombe KR , et al. Remdesivir: a review of its discovery and development leading to Emergency Use Authorization for treatment of COVID-19. ACS Cent Sci. 2020;6(5):672-683. doi:10.1021/acscentsci.0c00489 PubMed Google Scholar Crossref

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.