The Honorable Donald J. Trump
President of the United States
The White House
1600 Pennsylvania Avenue, Northwest
Washington, D.C. 20500

The Honorable Mike Pence
Vice President of the United States
1600 Pennsylvania Avenue, Northwest
Washington, D.C. 20500

Dr. Stephen M. Hahn
Commissioner of Food and Drugs
U.S. Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-002



Dear Mr. President, Mr. Vice President, and Dr. Hahn,

We need your help to resolve a very important and urgent problem that is preventing licensed physicians from prescribing Hydroxychloroquine (HCQ) for off-label uses.
 
Federal regulations allow health care professionals to lawfully prescribe or use FDA-approved drugs for both “on-label” and “off-label” uses. In other words, healthcare professionals may prescribe the use of drugs in ways that are not recommended or suggested on the FDA-approved labeling. See 59 Fed. Reg. 59, 820, 59, 821-22 (Nov. 18, 1994): “[O]nce a [drug] product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens of patient populations that are not included in approved labeling.”
 
On July 9, 2020, Dr. Deborah Birx stated to Drs. Simone Gold, Teryn Clark, and Richard Urso, and Tea Party Patriots Action Honorary Chairman Jenny Beth Martin that the FDA’s release of the Emergency Use Authorization (EUA) on HCQ allowed for physicians to prescribe HCQ in off-label uses for their patients, as they are permitted to do for all FDA-approved drugs. However, the FDA’s release of the EUA created a public perception that questioned both the effectiveness and safety of the use of HCQ, which in turn prompted many state medical and pharmacy boards to deny doctors the ability to prescribe this FDA approved drug for off-label uses. Thus, the government has inadvertently created a barrier between the doctor-patient relationship as it pertains to HCQ.
 
You do not need initials after your name to understand that if you restrict a life-saving medicine, more patients will die, and then if you un-restrict it, fewer patients will die.
 
On behalf of all of our families, friends, coworkers, and fellow citizens we demand that the American people have access to a safe, generic, widely-available drug that is routinely given to pregnant women, breastfeeding women, children, the elderly and the immune compromised since it was FDA-approved 65 years and billions of dosages ago. In order to clarify the public perception of HCQ and to restore the doctor-patient relationship, the FDA should immediately authorize an EUA stating that doctors are allowed to prescribe HCQ for outpatient use to treat or prevent COVID-19. Further, we demand that state and local administrative authorities do not impose any requirements on the prescription of Chloroquine (CQ), HCQ, azithromycin, or other drugs intended to treat or prevent coronavirus illness that do not apply equally to all approved medications that may be used off-label for any purpose.

Sincerely,

The Undersigned