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Johnson, Lee, Cruz Call for Explanation into FDA’s Emergency Use Authorization Decisions

WASHINGTON — U.S. Sens. Ron Johnson (R-Wis.), chairman of the Senate Homeland Security and Governmental Affairs Committee, Mike Lee (R-Utah), and Ted Cruz (R-Texas) sent a letter Tuesday requesting information regarding the U.S. Food and Drug Administration’s (FDA) decisions regarding hydrochloroquine (HCQ) and chloroquine (CQ) to treat COVID patients.


The senators wrote 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 10th, the FDA denied the EUA for outpatient use of HCQ by Henry Ford Health System physicians. …


“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. However, the physicians are concerned that the FDA’s actions regarding 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.”