UNIV 3985 Lecture Notes - Lecture 4: Hydroxychloroquine
Document Summary
The fda drug approval process is complex, well-regulated, scientifically rigorous, and works well to ensure safe and effective use of medications in patients. It takes a long time to bring a drug from development to clinical use!! Emergent events (epidemics, pandemics) make using the usual fda drug approval process impractical. Fda has mechanisms in place for emergent use of non-approved investigational drugs. Prescribers can use fda-approved drugs in an off-label manner with proper discretion and consideration of risks vs. benefits. At this time, all use of medications to treat covid-19 infection is considered off-label and/or experimental. Results from a randomized, blinded, placebo-controlled trial would provide better scientific evidence of a drug"s effectiveness than results from a retrospective case- control trial. Under current laws related to fda-mediated drug approval, a licensed physician can legally prescribe hydroxychloroquine to a patient with covid-19 infection.
