FDA Policy/General

Woodcock’s Priorities for FDA Under Califf

Appearing in a Milken Institute video interview with former FDA commissioner Margaret Hamburg, current acting commissioner Janet Woodcock said she hopes incoming commissioner Robert Califf will continue modernizing information technology in the agency as well as continuing to work to lower sodium in food and shepherding several user fee programs through Congress in 2022. She said that while the Covid-19 pandemic will continue to occupy the agency, those other priorities also need to be pursued.

Asked about the agency’s work during Covid, Woodcock said there were times when she felt like she was working as an intern again with the long hours and intense effort. “I think I have been able to effectively lead the staff in making plans and organizing people to carry them out,” she said. Agency staff members have been inundated, Woodcock said, with development programs and products and are “exhausted.”

Hamburg spent much of the interview on what Woodcock has learned about the need to change the conduct of clinical trials. Woodcock said it is hard to engage different communities in clinical research because research is not happening in the communities, but rather in medical centers. She said she is “hopeful, but not totally optimistic” that it is possible to make research and development more targeted.

In the future, Woodcock said, she expects that clinical trials will be changed to make better use of video technology, shift from product-centered to a patient-centered focus, use master protocols that consider the best outcomes for patients, engage community researchers, and engage people in research where they receive their ordinary care.

“Community care properly resourced and supported may be a more efficient way to conduct research,” Woodcock said.

Coming out of Covid a bit, she said the agency has exceeded the goals it set last spring for catching up on inspections. However, she added, “I’ve always felt FDA was critically under-resourced.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome