2020 AUG 31 FDA has not responded to @HSGAC letter

FDA REMAINS SILENT WHY:

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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 of hydroxychloroquine (HCQ) and chloroquine (CQ) to treat COVID-19 patients. Additionally, on August 10″, the FDA denied the EUA for outpatient use of HCQ by Henry Ford Health System physicians.’^[1]fn01: 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 … Continue reading

On May 29″, 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]fn02: Stephen M. Hahn, Bringing a Cancer Doctor’s Perspective to FDA’s Response to the COVID-19 Pandemic, FDA Voices (May 2020), … Continue reading 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]fn03: Id.

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 28″ 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 of HCQ 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]fn04: State Action on Hydroxychloroquine and Chloroquine Access, LUPUS FOUND. OF AM., https://www.lupus.org/advocate/state-action-onhydroxychloroquine-and-chloroquine-access (last updated July 30, … Continue reading

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]fn05: Early Treatment with Hydroxychloroquine: A Country-Randomized Controlled Trial, HCQ TRIALS (Aug. 5, 2020), https://hcqtrial.com/ (last updated Aug. 13, 2020). However, the physicians are concerned that the FDA’s actions regarding [The Honorable Stephen Hahn August 18, 2020 Page 2] HCQ maybe 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:

1. 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.

2. 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.

3. 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.

4. 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,

cc:  The Honorable Alex M. Azar II U.S. Department of Health and Human Services

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