BioCentury
ARTICLE | Politics, Policy & Law

Abernethy tackled ‘the blooming obvious’ at FDA by improving tech and data

Amy Abernethy says “country would be well-served” if Janet Woodcock is named commissioner

March 26, 2021 11:54 PM UTC

When Amy Abernethy joined FDA as principal deputy commissioner, “there were two things that were just blooming obvious,” she told BioCentury as she prepared to wind up a two-year stint at the agency.

The first was a swelling wave of applications, including for cell and gene therapies to treat rare diseases, that threatened to swamp FDA’s reviewers. It was equally clear that the agency couldn’t hire its way out of the problem. ...