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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

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

Mar 26, 2021 | 11:54 PM GMT

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.

“There was a massive pipeline of treatments coming that we all would hope would be available to ourselves and our children someday,” Abernethy said.

At the same time that “the number of potential therapies is going up, indications are getting smaller,” she said, and they are increasingly based on new modalities that are more complex than those that filled pharmacy shelves in the past.

This convergence,

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