One day after the FDA’s new director of the Center for Drug Evaluation and Research (CDER), Richard Pazdur, M.D., informed colleagues of his sudden and unexpected retirement, one of his lieutenants was moved out of her position.
Theresa Michele, M.D., the director of the Office of Nonprescription Drugs for a decade, has been transferred to another agency role, Fierce Pharma has learned. Michele has been assigned to a new leadership post at the FDA as the agency's Office of Nonprescription Drugs undergoes a restructuring as part of an initiative to make medicines more affordable.
Michele informed colleagues on Wednesday of the change, Stat News first reported, telling them that she would assume a post in the FDA’s medical devices center and that the change would take effect Thursday.
The move continues the leadership churn at the FDA. The agency has been in flux for 10 months since the confirmation of Department of Health and Human Services Secretary Robert F. Kennedy, Jr.
On Wednesday, the FDA announced vaccine critic Tracy Beth Høeg, M.D., Ph.D., would become the acting director of CDER. Høeg, who is the fifth official this year to head up CDER, helped lead the administration's investigation into COVID vaccinations.
Earlier this year, Peter Marks, M.D., Ph.D., resigned after nine years as director of the FDA’s Center for Biologics Evaluation and Research. In April, Marks said his departure was linked to his advocacy for vaccines.
As for the change of leadership at the Office of Nonprescription Drugs, the FDA signaled its intent three months ago to make more prescription drugs available over the counter.
“What we want people to do is focus on the benefit that we can provide to society by that switch,” George Tidmarsh, M.D., Ph.D., former CDER director, said at an industry conference at the time. “I encourage industry to really focus, in the broadest way, on the benefit of the switch. Not just the specifics of that, but the impact broadly in the health-care system.”
In December of last year, the FDA adjusted its guidelines for manufacturers in an effort to enable more OTC drugs to be developed and to expand consumer access.