Authorizations and Revocation of Emergency Use of Drugs During the COVID-19 Pandemic; Availability

AGENCY:

Food and Drug Administration, Health and Human Services (HHS).

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the issuance of four Emergency Use Authorizations (EUAs) (the Authorizations) for drugs for use during the COVID-19 pandemic. FDA issued four Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by the Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA), Fresenius Medical Care, Gilead Sciences, Inc., and Fresenius Kabi USA, LLC. The Authorizations contain, among other things, conditions on the emergency use of the authorized drugs. The Authorizations follow the February 4, 2020, determination by the Secretary of HHS that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus is now named SARS-CoV-2, which causes the illness COVID-19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. FDA is also announcing the subsequent revocation of the Authorization issued to BARDA for oral formulations of chloroquine phosphate and hydroxychloroquine sulfate. FDA revoked this authorization on June 15, 2020. The Authorizations, and the revocation, which include an explanation of the reasons for issuance or revocation, are reprinted in this document.

DATES:

The Authorization for BARDA was effective as of March 28, 2020, and the revocation of this Authorization is effective as of June 15, 2020; the Authorization for Fresenius Medical Care is effective as of April 30, 2020; the Authorization for Gilead Sciences, Inc. is effective as of May 1, 2020; the Authorization for Fresenius Kabi USA, LLC is effective as of May 8, 2020.

ADDRESSES:

Submit written requests for single copies of the EUAs to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a Fax number to which the Authorizations may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the Authorizations.

FOR FURTHER INFORMATION CONTACT:

Michael Mair, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-0002, 301-796-8510 (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives.

II. Criteria for EUA Authorization

Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces, including personnel operating under the authority of title 10 or title 50, United States Code, of attack with (i) a biological, chemical, radiological, or nuclear agent or agents; or (ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to U.S. military forces; (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or (4) the identification of a material threat by the Secretary of Homeland Security pursuant to section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or the health and security of U.S. citizens living abroad.

Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the Federal Register a notice of each authorization, and each termination or revocation of an authorization, and an explanation of the reasons for the action. Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use when the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use. Products appropriate for emergency use may include products and uses that are not approved, cleared, or licensed under sections 505, 510(k), 512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b, and 360e) or section 351 of the PHS Act (42 U.S.C. 262), or conditionally approved under section 571 of the FD&C Act (21 U.S.C. 360ccc). FDA may issue an EUA only if, after consultation with the HHS Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances), FDA concludes: (1) That an agent referred to in a declaration of emergency or threat can cause a serious or life-threatening disease or condition; (2) that, based on the totality of scientific evidence available to FDA, 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; or (ii) a serious or life-threatening disease or condition caused by a product authorized under section 564, approved or cleared under the FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, treating, or preventing such a disease or condition caused by such an agent; 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, taking into consideration the material threat posed by the agent or agents identified in a declaration under section 564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition; (4) in the case of a determination described in section 564(b)(1)(B)(ii), that the request for emergency use is made by the Secretary of Defense; and (5) that such other criteria as may be prescribed by regulation are satisfied.

No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act.

III. The Authorizations

The Authorizations follow the February 4, 2020, determination by the Secretary of HHS that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus is now named SARS-CoV-2, which causes the illness COVID-19. Notice of the Secretary's determination was provided in the Federal Register on February 7, 2020 (85 FR 7316). On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. Notice of the Secretary's declaration was provided in the Federal Register on April 1, 2020 (85 FR 18250). Having concluded that the criteria for issuance of the Authorizations under section 564(c) of the FD&C Act are met, FDA has issued four authorizations for the emergency use of drugs during the COVID-19 pandemic. On March 28, 2020, FDA issued an EUA to BARDA for oral formulations of chloroquine phosphate and hydroxychloroquine sulfate, subject to the terms of the Authorization. On April 30, 2020, FDA issued an EUA to Fresenius Medical Care for multiFiltrate PRO System and multiBic/multiPlus Solutions, subject to the terms of the Authorization. On May 1, 2020, FDA issued an EUA to Gilead Sciences, Inc. for remdesivir, subject to the terms of the Authorization. On May 8, 2020, FDA issued an EUA to Fresenius Kabi USA, LLC for Fresenius Propoven 2% Emulsion, subject to the terms of the Authorization. The Authorizations in their entirety (not including the authorized versions of the fact sheets and other written materials) follow, below section VI Electronic Access, and provide an explanation of the reasons for issuance, as required by section 564(h)(1) of the FD&C Act.

IV. EUA Criteria for Issuance No Longer Met

Under section 564(g)(2) of the FD&C Act, the Secretary of HHS may revoke an EUA if, among other things, the criteria for issuance are no longer met. On June 15, 2020, FDA revoked the EUA for BARDA for oral formulations of chloroquine phosphate and hydroxychloroquine sulfate because the criteria for issuance were no longer met. Under section 564(c)(2) of the FD&C 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: (1) The product may be effective in diagnosing, treating, or preventing such disease or condition and (2) 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. Based on a review of new information and a reevaluation of information available at the time the EUA was issued, FDA now concludes it is no longer reasonable to believe that (1) oral formulations of chloroquine phosphate and hydroxychloroquine sulfate may be effective in treating COVID-19 for the uses authorized in the EUA, or (2) the known and potential benefits of these products outweigh their known and potential risks for those uses. Accordingly, FDA revokes the EUA for emergency use of chloroquine phosphate and hydroxychloroquine sulfate to treat COVID-19, pursuant to section 564(g)(2) of the FD&C Act.

V. The Revocation

Having concluded that the criteria for revocation of the Authorization under section 564(g) of the FD&C Act are met, FDA has revoked the EUA for BARDA's oral formulations of chloroquine phosphate and hydroxychloroquine sulfate. The revocation in its entirety follows, below section VI. Electronic Access, and provides an explanation of the reasons for revocation, as required by section 564(h)(1) of the FD&C Act.

VI. Electronic Access

An electronic version of this document and the full text of the Authorizations and revocation are available on the internet at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.