“Janet Woodcock is the “right person” for the role of US Food and Drug Administration commissioner, the agency’s outgoing No. 2 official told Medtech Insight on 1 April.”
“’I feel very strongly about Janet Woodcock being the right person. I felt comfortable leaving my role because of the fact that Janet Woodcock is there,’ said Amy Abernethy, who will be leaving her job as FDA principal deputy commissioner later in April. More than two months into the Biden administration, it’s still unclear who will be selected as the next agency commissioner. Woodcock has been filling the role on an acting basis since 20 January.”
“Abernethy at one time was considered to be the frontrunner for the commissioner job, but that never materialized, we explained in our No. 1 story from last month. She was recruited to the FDA from the private sector by former commissioner Scott Gottlieb in early 2019. He left the agency roughly a month later.”
“In our recent interview with Abernethy, she said it was obvious to her from the get-go that the FDA needed to modernize its technology systems. The agency was swamped with work, she said, because its various systems didn’t talk to each other.”
“’It was clear to me that if we were going to scale the work of the agency, if we were going to be able to work more efficiently and faster, if we were going to be able to really leverage modern data sources, we were going to need to change the way that we use data and technology at the agency,’ Abernethy said.”
“As part of its ongoing technology efforts, the FDA will develop a Data Modernization Action Plan, or DMAP, that will allow the agency to make better regulatory decisions based on data. Woodcock and Abernethy announced DMAP in an early March blog post, we reported in our No. 8 story. The duo is confident the project will, among other things, help the FDA detect problems with approved products and better understand how products affect different populations.”
“Woodcock and Abernethy said DMAP complements the agency’s Technology Modernization Action Plan. Launched in September 2019, TMAP was set up to help the agency modernize its technology infrastructure, develop technology products to support its mission and collaborate with stakeholders to drive technological progress…” Read the full article here.
Source: FDA’s Outgoing Abernethy: ‘I Feel Very Strongly About Janet Woodcock’ — April 2, 2021. Medtech Insight.