Sklamberg Talks Legacy of Retiring FDA Commissioner Janet Woodcock

Life Sciences & Healthcare Regulatory partner Howard Sklamberg was recently featured in several articles speaking about the upcoming retirement of the U.S. Food and Drug Administration’s Commissioner Janet Woodcock and the lasting imprint she will leave on the agency when she leaves.

“I would say it is not an exaggeration to say she is one of the most consequential public health figures over the last 30 years,” Sklamberg told Regulatory Focus, adding that Woodcock “moved the agency forward” on real world evidence.

Sklamberg told Endpoints News that Woodcock’s “expertise and impact ranged from designing the modern drug approval process, reorganizing drug compliance and oversight, making countless critical drug approval decisions, establishing and overseeing the many programs that have accelerated patient access to important therapies, and more recently improving FDA’s food program.”

In Pink Sheet, Sklamberg said that Woodcock started thinking of succession planning more than a decade ago. However, there is still a concern about the institutional memory that will leave with her.

“What you miss is there are people who can do what she did. But it's hard to find somebody who is as proficient an issue spotter as she is in so many different areas,” Sklamberg said. “And the other thing is somebody who combines all the skills and all that knowledge, with a master ability to manage and get things done. ...Those are often very different skill sets.”

Read the Regulatory Focus article: “This Week at FDA: Woodcock’s irreplaceable legacy and an averted shutdown.”

Read the Enpoints News article: “FDA's Janet Woodcock to retire in early 2024” (subscription required).

Read the Pink Sheet article: “With Woodcock’s Retirement, US FDA Loses A Renaissance Woman” (subscription required).