Source: US Senate Authors: Ron Johnson, Mike Lee, Ted Cruz

WASHINGTON, DC 20510

August 18, 2020

The Honorable Stephen Hahn Commissioner

U.S. Food and Drug Administration 10903

New Hampshire Avenue Silver Spring, MD 20993

Dear Commissioner Hahn:

We are examining the U.S. Food and Drug Administration’s (FDA) efforts to provide potential treatments to patients suffering from COVID-19. Specifically, we write to request information regarding the FDA’ s decision to issue and then subsequently revoke the

Emergency Use Authorization (EUA) to permit the use ofhydroxychloroquine (HCQ) and chloroquine (CQ) to treat COVID-19 patients. Additionally, on August 1oth, the FDA denied the EUA for outpatient use ofHCQ by Henry Ford Health System physicians.1

On May 29th, you emphasized the importance of utilizing every possible treatment option to best address the needs of individual patients-including off-label prescribing of HCQ and CQ to treat or prevent COVID-19.2 You stated that the FDA does not regulate the practice of medicine and that prescribing off-label medicines like HCQ and CQ to treat COVID-19 is based on an individual assessment for the patient.3

However, we have heard from licensed physicians that have had a far different experience with the FDA’s approach. The physicians are concerned about the FDA’s decision to revoke the March 28th EUA for HCQ and CQ for treatment of COVID-19. They have described the clear differences between inpatient and outpatient treatments and how this decision has affected their ability to treat patients in different settings. The physicians have warned that the FDA’s EUA revocation ofHCQ and CQ has led to misinformation and confusion across the country. Some states have restricted the ability of physicians to write and pharmacies to fill HCQ and CQ prescriptions under the longstanding and well­ established authority to prescribe FDA approved drugs off-label with a patient’s informed consent and according to their clinical judgement.4

The licensed physicians we have heard from have stressed the potential benefits of early outpatient treatment of HCQ for individuals infected with COVID-19. These physicians have pointed to the low mortality rates in other countries – like India, Turkey, South Korea, and Morocco- that are using HCQ widely on outpatient COVID-19 populations before the disease progresses to more lethal stages of the virus that require hospitalization.5 However, the physicians are concerned that the FDA’s actions regarding

1 Letter from Dr. Peter Stein, Dir., Office of New Drugs, U.S. Food & Drug Admin., to Dr. John McKinnon, Fellowship Research Coordinator, Dep’t of Med., Henry Ford Hosp. (Aug. 10 2020) (on file with Majority Staff, U.S. Senate Committee on Homeland Security and Governmental Affairs) .

2 Stephen M. Hahn, Bringing a Cancer Doctor’s Perspective to FDA ‘s Response to the COVID-19 Pandemic, FDA Voices (May 2020), https://www.fda.gov/news-events/fda-voices/bringing-cancer-doctors-perspective-fdas-resoonse-covid19-pandemi c.

3 Id.

4 State Action on Hydroxychloroquine and Chloroquine Access, LUPUS FOUND. OF At-.1., https://www.lupus.org/advocate/state-action-on­ hydroxychloroguine-and-chloroguine-access (last updated July 30, 2020). Following the  FDA’s  revocation  of the  EUA for  HCQ  and CQ on June 15, 2020, Arkansas and Kansas updated state guidance regarding HCQ and CQ use for COVID-19. Id. Both states cited the FDA’s revocation in their updated guidance, and Arkansas stated that based on the FDA’s June 15 revocation, HCQ and CQ should be avoided in both outpatient and hospitalized settings as a treatment for COVID -19. Id.

5 Early Treatment with Hydroxych loroquine: A CountryRandomized Controlled Trial, HCQ TRIALS (Aug. 5, 2020), https://hcqtrial.com/ (last updated Aug. 13, 2020) .

HCQ may be directly costing lives by limiting outpatient access to this potentially beneficial treatment. Physicians taking care of patients in our communities across the country must be free to make the best medical and treatment decisions for their patients, use their “off label” prescription rights, and have full access to FDA approved drugs.

To better understand the FDA’s decisions regarding HCQ and CQ, we respectfully request the following information:

  • Please provide any studies and data that informed the FDA’s apparent determination that giving HCQ or CQ to COVID-19 infected outpatients within seven days from the onset of symptoms, under a doctor’s supervision, will have no clinical effect and may be harmful to the patient.
  • Please provide any scientific studies, medical papers and data involving COVID-19 outpatients that have started HCQ or CQ under a doctor’s supervision and begun in the ambulatory care outpatient setting. This includes post-exposure outpatient treatment and/or pre-exposure prophylaxis. This should not include late stage studies involving patients started on HCQ while in hospital.
  • Please provide any public statements or records that FDA has issued to clarify that the FDA does not regulate the practice of medicine and that state governments may not regulate the sale or prohibit the sale of prescription drugs.
  • Please provide any potential treatments for COVID-19 that have been utilized internationally, whether those treatments are authorized or approved by the FDA, and what steps the FDA has taken to ensure that these treatments are available in the U.S.

Please provide this material as soon as possible but no later than 5:00 p.m. on August 25, 2020.

If you have any questions about this request, please ask your staff to contact Shani Rosenstock and Josh McLeod of Senator Johnson’s staff at (202) 224-4751. Thank you for your attention to this urgent matter and your continued leadership.

Sincerely,

Ron Johnson, United States Senator

Mike Lee, United States Senator

Ted Cruz, United States Senator




Related: Sen. Johnson seeks action on hydroxychloroquine use

Ron Johnson sends doctors’ note to Trump urging action on hydroxychloroquine

Death toll mounts as FDA denies HCQ for outpatient therapy

New Jersey lawmaker bangs the drum for hydroxychloroquine

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