Ex. G: U.S. Food & Drug Administration to Simone Gold, April 8, 2021 — No. 2:21-cv-00702 (Dkt. 15-7)

Summary

A letter dated April 8, 2021 from the U.S. Food & Drug Administration to Simone Gold of America's Frontline Doctors, Re: Docket No. FDA-2020-P-2066, filed July 19, 2021 as Document 15-7 in Case 2:21-cv-00702-CLM. The letter states that FDA has not yet resolved the issues raised in a citizen petition received on October 13, 2020, which asks the Agency to exempt Plaquenil and equivalent hydroxychloroquine sulfate based drugs for COVID-19 prophylaxis from prescription-dispensing requirements under 21 U.S.C. § 353(b)(3) and 21 C.F.R. § 310.200(b). It says the petition raises complex issues requiring extensive review and analysis and calls itself an interim response under 21 CFR 10.30(e)(2). It is digitally signed by Carol J. Bennett, Deputy Director, Office of Regulatory Policy, Center for Drug Evaluation and Research.

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Case 2:21-cv-00702-CLM Document 15-7 Filed 07/19/21 Page 1 git G FILED
f i Bil U.S. FOOD & DRUG eget

. ADMINISTRATION N.D. OF ALABAMA

Simone Gold

America's Frontline Doctors c/o Free Speech Foundation
2934-1/2 Beverly Glen Circle #314

Los Angeles, CA 90077

Sent via email to: info@aflds.com

April, 8, 2021
Re: Docket No. FDA-2020-P-2066

Dear Ms. Gold:

I am writing to inform you that the Food and Drug Administration (FDA) has not yet resolved
the issues raised in your citizen petition received on October 13, 2020. Your petition requests
that the Agency exempt from prescription-dispensing requirements Plaquenil™ and equivalent
hydroxychloroquine sulfate based drugs for use in COVID-19 prophylaxis, pursuant to 21 U.S.C.
§ 353(b)(3) and 21 C.F.R. § 310.200(b),.

FDA has been unable to reach a decision on your petition because it raises complex issues
requiring extensive review and analysis by Agency officials. This interim response is provided
in accordance with FDA regulations on citizen petitions (21 CFR 10.30(e)(2)). We will respond
to your petition as soon as possible given the numerous demands on the Agency's resources.

Sincerely,

Digitally signed by Caro! Bennett -S
IN: c=US, o=U.S. Government, ou=HHS,

Ca rol Be n nett «SF Me ou=People, cn=Carol Bennett -S,

0:9:2342.19200300.100.1.1=2000004958
Date: 2021.04.08 10:22:59 -04'00'

Carol J. Bennett

Deputy Director

Office of Regulatory Policy

Center for Drug Evaluation and Research

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov


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