President Trump’s hiring freeze on civilian employees will exacerbate the Center for Drugs Evaluation & Research’s existing difficulties in recruiting and retaining qualified individuals. CDER is currently 591 positions under the hiring ceiling, include 50 open positions within CDER management.
The federal hiring freeze implemented by the Trump Administration adds another challenge to the ongoing struggle by FDA’s Center for Drug Evaluation & Research to recruit and retain qualified individuals to fill both open executive leadership positions and vacancies within its drug review teams.
While CDER’s recruitment challenges are longstanding and well-publicized by the 21st Century Cures legislative discussion, the Jan. 23
The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.
Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
Pfizer still has not submitted a supplemental biologics license application for the youngest population even though people familiar say it has dominated that market. Moderna says it can “step up” supply.
Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.
