Assistant HHS secretary for health has led policy development for several offices since his 2018 confirmation and also has industry and clinical experience.
Adm. Brett Giroir, currently Health and Human Services assistant secretary for health, will become acting US Food and Drug Administration Commissioner, ending the tenure of Norman Sharpless, and giving the agency an experienced political official as its temporary chief.
Giroir became the acting head of the FDA in conjunction with the nomination of Stephen Hahn to be the permanent...
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Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.
The new CDER director focused on plans to improve morale during an Aug. 8 townhall, but staff comments indicate that may be a challenge.
New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.
Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.
A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
After the abrupt departure of CBER’s director, it seems FDA, and Vinay Prasad in particular, would likely have been well served by hearing from an advisory committee before requesting the suspension in sales of Sarepta’s DMD gene therapy Elevidys.
