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FDA withdraws emergency use authorization for hydroxychloroquine

By | Rachel Brooks

Staff | Telegraph Local 

See | The New African Living Standard

Generic drug testing at the FDA in 2016, Public Domain License.

The FDA withdraws the emergency use of hydroxychloroquine in the treatment of COVID-19. This was reported by NPR News at 2:30pm ET on June 15. The US Food and Drug Administration had previously instituted a special emergency use of hydroxychloroquine for the treatment of coronavirus. Yet, the FDA has now issued an official letter revoking that emergency status believing that hydroxychloroquine is not effective in the treatment of COVID-19. 

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The letter was addressed to Gary L. Disbrow, Ph.D. who works as a Deputy Secretary/ Director of Medical Countermeasure Programs with the Biomedical Advanced Research and Development Authority,  U.S. Department of Health and Human Services. It was written by RADM Denise M. Hinton the Chief Scientist at the Food and Drug Administration. The letter included an introductory statement addressing Dr. Disbrow’s request that the emergency status of hydroxychloroquine as a viable COVID-19 drug be removed. It then included a memorandum explaining the basis for this revocation. 

“Dear Dr. Disbrow: This letter is in response to your request, dated today, that the Food and Drug Administration (FDA) revoke the Emergency Use Authorization (EUA) for emergency use of oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) to be distributed from the Strategic National Stockpile (SNS) issued on March 28, 2020,” begins the letter that was dated for June 15. 

“Like BARDA’s earlier request to FDA to issue the EUA, BARDA’s request to revoke the EUA is part of a collaborative, USGinteragency effort to rapidly respond to this continuously evolving public health emergency. 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 [Coronavirus Disease 2019] and that the drug’s potential benefits for such use do not outweigh its known and potential risks,” proceeds the letter, which then goes on to highlight legal code regarding the revocation. 

“The authorization of a product for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act, be revised or revoked when the criteria under section 564(b)(1) of the Act no longer exist, the criteria under section 564(c) of the Act for issuance of such authorization are no longer met, or other circumstances make such revision or revocation appropriate to protect the public health or safety. FDA has determined that the criteria under section 564(c) of the Act for issuance of the EUA referenced above are no longer met…,” continues the letter, which then goes on to include the memorandum of findings. 

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The entire text of the letter is available at FDA.gov. 

Reuters reports that despite the FDA’s decision to revoke the emergency status of the antimalarial drugs as COVID-19 treatment viable, U.S. President Trump continues to promote its coronavirus use. Trump stated publicly on Monday that “other countries” had achieved success with the drug. Mr. Trump has not yet commented via his Twitter regarding the revocation.  

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