Presented September 5th, 2018 at APSF Stoelting Conference 2018
SUMMARY
Point 1: The premarket evaluation of every drug is incomplete. It is only after substantial use in large populations post-marketing that we can have a complete understanding of the safety and efficacy in a diverse group of patients.
Point 2: The testing of all drugs marketed for human consumption must be complete and must reflect all of the clinical conditions under which the drug will be used.
Point 3: No system of governance, where secrecy is a defining characteristic, can be expected to provide consistent, rational answers to difficult questions. The insular nature of large government organizations may focus on protecting past missteps rather than improving future processes.
Point 4: The Agency has fifteen thousand employees and a budget of 5.4 billion dollars. However, many times the authority of the Agency fails to allow leadership to make substantial changes rapidly.
PRESENTATION MATERIALS
FDA and Generic Drug Labeling Updates – [PDF]
ABOUT THE SPEAKER(S)
Raeford Brown, MD
Rae Brown is a professor of Anesthesiology and Pediatrics at the University of Kentucky. While in Lexington he has served as Executive Vice Chair of the Department of Anesthesiology, and the Chief of Pediatric Anesthesiology and Pain Medicine at the Kentucky Children’s Hospital. At UK Medical Center, Dr Brown has served as Associate Chief of Staff responsible for Mortality Reduction, as well as The Medical Director of Perioperative Services.
Currently, Dr Brown serves as the Chair of the FDA Advisory Committee on Analgesic and Anesthetic Drug Products, Chair of the Section on Anesthesiology and Pain Medicine of the American Academy of Pediatrics, and as a consultant on opioid use in children for the Centers for Disease Control and Prevention.