FDA’s Woodcock Moving Away from Drugs

Longtime Director of the Center for Drug Evaluation and Research CDER, Janet Woodcock, will be changing roles at the US Food & Drug Administration (FDA) and moving away from drug regulating. It is still unclear what her new role will entail.

Rob Califf, the new FDA commissioner recently announced in a staff memo that Janet Woodcock, longtime CDER director, would be moving to a role as “a strategic thought partner, with decision-making authorities” at several offices within FDA, not including the Office of New Drugs or the Office of Generic Drugs.

This move, away from drug regulating comes after a long career at the FDA where Woodcock has held a number of senior leadership positions, including terms as the Director of Center for Drug Evaluation and Research (CDER) from 1994 to 2004 and 2007 to 2021. In 2020 PharmaBoardroom interview, Woodcock reflected on her long career at the agency: “My focus has been on ensuring that we do the very best for the public. We are public servants, so we have to efficiently and effectively deliver on a mission.”

Woodcock is known for modernising the CDER and the FDA, introducing initiatives to improve the timeliness and transparency of FDA procedures, and the safety, quality and effectiveness of drugs.  She has also moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed since the beginning of the pandemic, where she leads the drive for work on COVID-targeted mAbs and antivirals.

The agency has not revealed more details, but in his statement, Califf said: “Let me be clear that this organizational adjustment is to maximize Janet’s leadership experience to help support these important components of the FDA, including a cross-cutting focus on enterprise excellence.”

It is yet unknown what Woodcock’s new role will involve, but judging from the blog post she and Meredith Chuk, director of FDA’s Enterprise Transformation Operation, posted about the agency’s infrastructure modernization plans shortly after the staff memo, it may be related to infrastructure.