Senators Demand Answers on Hydroxychloroquine from the FDA

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Senator Ron Johnson (R-Wis.), Chairman of the Homeland Security and Governmental Affairs Committee, along with Sen. Mike Lee (R-Utah) and Sen. Ted Cruz (R-Texas), in a letter to Food and Drug Administration (FDA) Commissioner Stephen Hahn, write that “the FDA’s actions regarding [hydroxychloroquine] HCQ may be directly costing lives by limiting outpatient access to this potentially beneficial treatment.”

On May 29, Dr. Hahn stated: “Prescribing a product for uses not specifically included in the official labeling is common in the practice of medicine. In oncology and mental health, many patients are treated this way.”

He notes that with COVID-19 “health care professionals are looking for every possible treatment option for their patients,” and that patients and their doctors “must ultimately decide what treatment is likely to be best for the individual patient.”

Dr. Hahn recognizes that “hydroxychloroquine and chloroquine have received particular attention. Both are FDA-approved to treat or prevent malaria, and hydroxychloroquine is also approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis. They have been prescribed for years to help patients with these debilitating, or even deadly, diseases and have a well-established safety profile for these conditions.”

Despite these statements, the senators write that FDA’s actions on HCQ have “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.”

The senators ask the FDA to provide the Committee, by Aug 25, with all information pertaining to FDA decisions that discourage the outpatient use of HCQ for early treatment or prophylaxis of COVID-19, and also “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.”

“The licensed physicians we have heard from… 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.”

The senators conclude: “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.”

AAPS has represented physicians of all specialties in all states since 1943. The AAPS motto is omnia pro aegroto, meaning everything for the patient.