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---
title: FDA Revokes Emergency Authorization for Hydroxychloroquine
description: The U.S. FDA says that studies show little benefit of hydroxychloroquine for COVID-19 patients, and relatively high risks of using the drug.
canonical: https://time.com/5853826/fda-hydroxychloroquine/
author: Tara Law
article:opinion: false
article:content_tier: free
article:published_time: 2020-06-15T18:42:51.000Z
article:modified_time: 2026-08-04T07:52:05.212Z
article:section: Health
og:title: FDA Revokes Emergency Authorization for Hydroxychloroquine
og:description: The U.S. FDA says that studies show little benefit of hydroxychloroquine for COVID-19 patients, and relatively high risks of using the drug.
og:url: https://time.com/5853826/fda-hydroxychloroquine/
og:site_name: TIME
og:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt96cb6f5a370488f1/698a0f4d656a3f490bbda395/Hydroxychloroquine.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9
og:image:width: 5157
og:image:height: 2901
og:image:alt: US-HEALTH-VIRUS-MEDICINE
og:type: article
twitter:card: summary_large_image
twitter:title: FDA Revokes Emergency Authorization for Hydroxychloroquine
twitter:description: The U.S. FDA says that studies show little benefit of hydroxychloroquine for COVID-19 patients, and relatively high risks of using the drug.
twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt96cb6f5a370488f1/698a0f4d656a3f490bbda395/Hydroxychloroquine.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9
video:duration: 01:10
video:published: 2020-05-20
section: health
topics: hydroxychloroquine, coronavirus treatment, FDA guidance, clinical studies, drug safety, VA study, medical criticism
genre: press remarks, interview
tones: defensive, assertive, combative, confident
emotions: defiance (high), confidence (medium), suspicion (medium)
sentiment: negative
audience: general public, health-conscious readers, policy watchers, news consumers
people: Donald Trump
organizations: FDA, VA
products: hydroxychloroquine
content_suitability: health controversy [00:00-01:10]; death [00:05-00:29]; politics [00:05-01:10]
transcript_source: automatic transcription
transcript_reviewed: not applicable
---

![](https://static.time.com/v3/assets/bltea6093859af6183b/blt96cb6f5a370488f1/698a0f4d656a3f490bbda395/Hydroxychloroquine.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9)


# The FDA Revokes Emergency Use Authorization for Hydroxychloroquine, Citing New Evidence

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<!-- video src="https://cdn.jwplayer.com/manifests/oBDiXQ8h.m3u8" -->
## Video: President Trump Defends His Hydroxychloroquine Use Amid Concerns

[Watch (HLS stream): President Trump Defends His Hydroxychloroquine Use Amid Concerns](https://cdn.jwplayer.com/manifests/oBDiXQ8h.m3u8) (1:10)

![President Trump Defends His Hydroxychloroquine Use Amid Concerns](https://cdn.jwplayer.com/v2/media/oBDiXQ8h/poster.jpg?width=720)

_Published 2020-05-20. President Trump emphatically defended himself against criticism from medical experts that his announced use of a malaria drug against the coronavirus could spark wide misuse by Americans of the unproven treatment with potentially fatal side effects._
Description, summary, key points, chapters, key quotes, questions and transcript, where present, were produced automatically from the video or its captions and were not reviewed.

## Summary
President Trump defends his use of hydroxychloroquine against the coronavirus, pushing back on concerns from medical experts. He says a study showing harm was flawed, pointing to very sick patients who were old and had heart problems and diabetes. He cites studies from Italy, France and Spain and says the drug seems very safe, while calling a VA study a phony study.

## Key points
- The FDA has said hydroxychloroquine should not be used outside of a hospital setting. (00:00)
- Trump says he was not told that hydroxychloroquine should be restricted to hospitals and rejects that claim. (00:05)
- Trump claims a study that found harm gave the drug to extremely sick people who were ready to die. (00:05)
- Trump says the patients in that study were old and had bad hearts, diabetes and other problems. (00:05)
- Trump says the study that produced false information was given to very sick patients by people he says were not friends of the administration. (00:05)
- Trump says great studies came out of Italy on hydroxychloroquine and mentions studies from France and Spain. (00:34)
- Trump says hydroxychloroquine is worth it as a line of defense and that he will stay on it for a while longer. (00:55)
- Trump says the drug seems very safe but calls a VA study a phony study. (01:02)

## Chapters
- [00:00 to 00:29] Disputing claims about hospital-only use and study. Trump rejects the FDA hospital-only guidance and criticizes a study of very sick patients as flawed.
- [00:29 to 00:45] Citing international studies on the drug. Trump says false information was spread and points to studies from Italy on hydroxychloroquine.
- [00:45 to 01:10] Defending the treatment as a line of defense. Trump describes studies from several countries, calls the drug worth trying and says it seems safe, while dismissing a VA study.

## Key quotes
- [00:05] President Trump: "There was a false study done where they gave it to very sick people, extremely sick people."
- [00:05] President Trump: "People that were ready to die."
- [00:55] President Trump: "I think it's worth it as a line of defense and I'll stay on it for a little while longer."
- [01:02] President Trump: "But that study was a phony study put out by the VA."

## Questions this video answers
- What did the FDA say about using hydroxychloroquine? [00:00]
- Why does Trump say the study showing harm is flawed? [00:05]
- Which countries' studies does Trump cite as showing benefit? [00:34]
- Why does Trump say he is using hydroxychloroquine? [00:55]
- How does Trump characterize the safety of the drug? [01:02]

## Content suitability
- health controversy [00:00-01:10]: Discussion of an unproven COVID-19 treatment and disputed safety claims about the drug.
- death [00:05-00:29]: References to very sick patients who were ready to die.
- politics [00:05-01:10]: Political figure disputing medical findings and accusing officials of bias.


![Tara Law](https://static.time.com/v3/assets/bltea6093859af6183b/blt2d9ed2f15fe37660/698a1292929fad68eabf6978/Tara_law.jpeg?branch=production&width=1200&quality=75&auto=webp&crop=1:1)

by 

[Tara Law](https://time.com/author/tara-law/)


![Tara Law](https://static.time.com/v3/assets/bltea6093859af6183b/blt2d9ed2f15fe37660/698a1292929fad68eabf6978/Tara_law.jpeg?branch=production&width=96&quality=75&auto=webp)

## Tara Law


Jun 15, 2020 6:42 PM UTC

![US-HEALTH-VIRUS-MEDICINE](https://static.time.com/v3/assets/bltea6093859af6183b/blt96cb6f5a370488f1/698a0f4d656a3f490bbda395/Hydroxychloroquine.jpg?branch=production&width=1200&quality=75&auto=webp&crop=3:2)

A pharmacy tech pours out pills of Hydroxychloroquine at Rock Canyon Pharmacy in Provo, Utah, on May 20, 2020\. - US President Donald Trump announced May 18 he has been taking hydroxychloroquine for almost two weeks as a preventative measure against COVID-19\. (Photo by GEORGE FREY / AFP) (Photo by GEORGE FREY/AFP via Getty Images)

A pharmacy tech pours out pills of Hydroxychloroquine at Rock Canyon Pharmacy in Provo, Utah, on May 20, 2020\. - US President Donald Trump announced May 18 he has been taking hydroxychloroquine for almost two weeks as a preventative measure against COVID-19\. (Photo by GEORGE FREY / AFP) (Photo by GEORGE FREY/AFP via Getty Images) George Frey—AFP/Getty Images

![Tara Law](https://static.time.com/v3/assets/bltea6093859af6183b/blt2d9ed2f15fe37660/698a1292929fad68eabf6978/Tara_law.jpeg?branch=production&width=1200&quality=75&auto=webp&crop=1:1)

by 

[Tara Law](https://time.com/author/tara-law/)


![Tara Law](https://static.time.com/v3/assets/bltea6093859af6183b/blt2d9ed2f15fe37660/698a1292929fad68eabf6978/Tara_law.jpeg?branch=production&width=96&quality=75&auto=webp)

## Tara Law


Jun 15, 2020 6:42 PM UTC

The U.S. Food and Drug Administration (FDA) announced today that it is revoking the emergency use authorization for hydroxychloroquine and chloroquine, citing a lack of evidence that these drugs are effective for COVID-19.

Early on in the pandemic, doctors scrambling to find a way to treat the disease [widely prescribed](https://time.com/5808894/hydroxychloroquine-coronavirus/) hydroxychloroquine to their sickest patients, based on thin evidence from a handful of relatively weak studies. However, recent research has made it increasingly clear that the drug is [likely](https://www.statnews.com/2020/06/05/hydroxychloroquine-had-no-benefit-for-hospitalized-covid-19-patients-possibly-closing-door-to-use-of-drug/) [ineffective](https://time.com/5833945/hydroxychloroquine-coronavirus-study/) against the disease, and that it carries a risk of significant side effects, including heart problems.

The chief scientist for the FDA, Denise M. Hinton, announced the decision [in a letter](https://www.fda.gov/media/138945/download) to the Biomedical Advanced Research and Development Authority (BARDA) on Monday. “Today’s request to revoke is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat COVID-19,” she wrote, adding that it is “no longer reasonable” to believe that the drug combination’s benefits outweigh the potential side effects.

Hydroxychloroquine is a slightly different version of chloroquine, a drug discovered to fight malaria decades ago. Scientists developed hydroxychloroquine as a replacement for malaria treatment, with fewer side effects; today, in the U.S. it’s mainly prescribed to treat the inflammation related to autoimmune disorders like rheumatoid arthritis and lupus.


As the U.S. pandemic surged in March, President Donald Trump championed hydroxychloroquine as a potential COVID-19 treatment, calling it a possible “[game-changer](https://www.youtube.com/watch?v=ScdYrN3BWTM).” Trump [encouraged others](https://time.com/5808894/hydroxychloroquine-coronavirus/) to take the drug, and later claimed to have undergone a [two-week regimen](https://www.nbcnews.com/politics/donald-trump/trump-says-he-s-no-longer-taking-hydroxychloroquine-n1214301) of hydroxychloroquine himself in an effort to ward off the disease. Medical experts [widely criticized](https://www.nytimes.com/2020/05/18/us/politics/trump-hydroxychloroquine-covid-coronavirus.html) President Trump for promoting a potentially dangerous drug before its benefits were proven, and warned of the possible risks of the public self-medicating.

The FDA said in a [statement](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and) on Monday that the FDA regularly reviews drugs under an emergency use authorization, and has reviewed new information, including a large clinical trial of hospitalized patients that showed that the drug didn’t appear to help people get better faster, or reduce the risk of mortality.

“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate. This action was taken following a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” Dr. Patrizia Cavazzoni, the acting director of the FDA’s Center for Drug Evaluation, said in the statement.

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