She Didn’t Need To Be Commissioner: Janet Woodcock’s Transformative Legacy

She is as polarizing as she is powerful, but whether you think Janet Woodcock is drug development’s hero or public health’s enemy, there’s no denying she dramatically transformed the US FDA over her 35-year career.

Woodcock legacy portrait. (Source: Nielsen Hobbs; the Pink Sheet | Images from Alamy, FDA, Shutterstock)
Janet Woodcock's smile might not be enigmatic, but her legacy is complicated. • Source: Nielsen Hobbs; the Pink Sheet | Images from Alamy, FDA, Shutterstock

After a 35-year career, Janet Woodcock is expected to wind down her time at the US Food and Drug Administration in 2022 having never held the agency’s most senior role – commissioner – permanently. But that hasn’t stopped her from being one of the most powerful forces in modern drug regulation, and in fact may have been what kept her so influential for such a long period of time.

Unlike a commissioner, Woodcock’s period of leadership wasn’t limited to a few years, and her other FDA posts came with...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from US FDA

CAR-T REMS Removal Should Boost Access, But Long-Term Follow-Up, Black Box Remain

 

The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.

PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

 

Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.

BIO CEO On Industry And US FDA, Trump’s Vaccine Views And MFN Counter Proposals

 

John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.

New CDER Deputy Director Michael Davis Brings Psychedelic Drug Development Experience

 
• By 

Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.

More from Agency Leadership

BIO CEO On Industry And US FDA, Trump’s Vaccine Views And MFN Counter Proposals

 

John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.

Quotable: Top Experts On Policy Hot Topics

 

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

New CDER Deputy Director Michael Davis Brings Psychedelic Drug Development Experience

 
• By 

Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.