Missed Opportunities in the FDA’s Emergency Use Authorization of Remdesivir | Law and Medicine | JN Learning | AMA Ed Hub [Skip to Content]
[Skip to Content Landing]

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

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).

Sign in to take quiz and track your certificates

Buy This Activity

JN Learning™ is the home for CME and MOC from the JAMA Network. Search by specialty or US state and earn AMA PRA Category 1 CME Credit™ from articles, audio, Clinical Challenges and more. Learn more about CME/MOC

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
1.
Federal Food, Drug, and Cosmetic Act, §360bbb-3: Authorization for medical products for use in emergencies, 21 USC §360bbb–3 (2011).
2.
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 PubMedGoogle Scholar
3.
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 PubMedGoogle Scholar
4.
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 PubMedGoogle ScholarCrossref
5.
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
6.
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
7.
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 PubMedGoogle ScholarCrossref
8.
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.2020.11464Google Scholar
9.
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.mm6915e3PubMedGoogle ScholarCrossref
10.
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 PubMedGoogle ScholarCrossref
If you are not a JN Learning subscriber, you can either:
Subscribe to JN Learning for one year
Buy this activity
jn-learning_Modal_Multimedia_LoginSubscribe_Purchase
Close
If you are not a JN Learning subscriber, you can either:
Subscribe to JN Learning for one year
Buy this activity
jn-learning_Modal_Multimedia_LoginSubscribe_Purchase
Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close

Name Your Search

Save Search
Close
With a personal account, you can:
  • Track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
jn-learning_Modal_SaveSearch_NoAccess_Purchase
Close

Lookup An Activity

or

Close

My Saved Searches

You currently have no searches saved.

Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close