FDA Commissioner Scott Gottlieb Steps Down After Almost Two Years. Gottlieb Took Critical Steps to Advance Alzheimer’s Drug Development During His Tenure.

March 5, 2019 –UsAgainstAlzheimer’s (UsA2) thanks U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb for his service at the agency, following the announcement that he will be stepping down next month. UsA2 commends Commissioner Gottlieb for his leadership of the FDA and for the strides made during his tenure to prioritize the development of new treatments for Alzheimer’s Disease.

“UsAgainstAlzheimer’s thanks Commissioner Gottlieb for his service to the FDA and for the Agency’s support of those living with Alzheimer’s disease and their families. In particular, we applaud the release of the FDA’s industry guidance, Early Alzheimer’s Disease: Developing Drugs for Treatment, which reflects the Agency’s commitment to the patient community and to addressing Alzheimer’s Disease,” said UsAgainstAlzheimer’s Chairman George Vradenburg. “Commissioner Gottlieb and the FDA’s responsiveness to the patient community will prove instrumental in paving the way for new treatments that millions of families so desperately await.”

Under the FDA’s new guidance, the FDA formally rejected its previous approach to approving new medicines for Alzheimer’s, which required that a drug prove a benefit to both cognition and function. Instead, the FDA recognized the potentially clinically meaningful nature of either changes in cognition or function and will allow a drug to be approved if it improves either cognition or function. This important industry guidance is indicative of the FDA’s support of patient preference under Commissioner Gottlieb’s leadership.

“It is imperative that President Trump quickly nominate a new FDA Commissioner to ensure that the momentum built by Commissioner Gottlieb and Congress is sustained. The work being done to develop treatments and accelerate a cure for Alzheimer’s must seamlessly continue,” added Vradenburg. “Whomever the nominee is, he or she must be dedicated to advancing new and existing treatments for Alzheimer’s. UsA2 looks forward to continuing its work with the FDA to improve the Alzheimer’s drug development process and expedite new therapies for this dreadful disease.”

###