June 15, 2020
Gary L. Disbrow Ph.D. Deputy Assistant Secretary Director, Medical Countermeasure Programs Biomedical Advanced Research and Development Authority (BARDA) Office of Assistant Secretary for Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) 330 Independence Ave, S.W., Room 640G Washington, D.C. 20201
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. 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.
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. Under section 564(c)(2) of the Act, an EUA may be issued only if FDA concludes “that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that: (A) the product may be effective in diagnosing, treating, or preventing—(i) such disease or condition [….]; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product […].”
As explained in the attached memorandum, based on a review of new information and a reevaluation of information available at the time the EUA was issued, FDA now concludes that these criteria are no longer met. The bases for this decision include the following:
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FDA has concluded that, based on this new information and other information discussed in the attached memorandum, it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks. Accordingly, FDA revokes the EUA for emergency use of HCQ and CQ to treat COVID-19, pursuant to section 564(g)(2) of the Act. As of the date of this letter, the oral formulations of HCQ and CQ are no longer authorized by FDA to treat COVID-19.
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FDA REVOKES Emergency Use Authorization (EUA) for emergency use of oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ)
As explained in the attached memorandum, based on a review of new information and a reevaluation of information available at the time the EUA was issued, FDA now concludes that these criteria are no longer met. The bases for this decision include the following:
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