2022-15956. Revocation of Emergency Use of a Drug During the COVID-19 Pandemic; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Gilead Sciences, Inc. (Gilead) for VEKLURY (remdesivir). FDA revoked the Authorization on April 25, 2022, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) given the approval of a supplemental new drug application (NDA) for VEKLURY, which expanded the approved indication to cover the authorized population. The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.

DATES:

The Authorization is revoked as of April 25, 2022.

ADDRESSES:

Submit written requests for single copies of the Authorization and/or revocation 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. 4340, 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) as amended by the Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) 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. On May 1, 2020, FDA issued an Authorization (EUA 046) to Gilead for remdesivir, subject to the terms of the Authorization. Notice of the issuance of the Authorization was published in the Federal Register on September 11, 2020 (85 FR 56231), as required by section 564(h)(1) of the FD&C Act. Subsequent amendments to the Authorization on August 28, 2020, October 1, 2020, October 16, 2020, October 22, 2020, and January 21, 2022, were made available on FDA's website.

II. 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 April 25, 2022, FDA revoked the EUA for VEKLURY because the criteria for issuance were no longer met. Under section 564(c)(3) of the FD&C Act, an EUA may be issued only if FDA concludes there is no adequate, approved,^[1] and available alternative to the product for diagnosing, preventing, or treating the disease or condition. On April 25, 2022, FDA approved a supplemental NDA to NDA 214787 for VEKLURY, which expanded the approved indication to the following:

Veklury is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleotide analog RNA polymerase inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct SARS-CoV-2 viral testing, who are:

• Hospitalized, or
• Not Hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

FDA has concluded that VEKLURY approved under NDA 214787 is an adequate, approved, and available alternative to the VEKLURY available for emergency use for the treatment of COVID-19 for purposes of section 564(c)(3) of the FD&C Act. Accordingly, FDA revoked EUA 046 for emergency use of VEKLURY, pursuant to section 564(g)(2) of the FD&C Act.

III. Electronic Access

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

IV. 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 Gilead's VEKLURY (remdesivir). The revocation in its entirety follows and provides an explanation of the reasons for revocation, as required by section 564(h)(1) of the FD&C Act.

Dated: July 19, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.

Footnotes

1.  In the context of section 564, the term “approved” refers to a product that is approved, licensed, or cleared under section 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k), or 360(e)) or section 351 of the Public Health Service Act (42 U.S.C. 262). See section 564(a)(2) of the FD&C Act.