Spirits of FDA Past: Reality or Apparitions?

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ARTICLE SUMMARY:

The speculation about possible roles in the new administration’s FDA for David Kessler and Joshua Sharfstein conjures up images of a bygone era characterized by frosty relations between industry and regulators, raising concerns about reversing the progress that has since been achieved.

One of the results of the pandemic is that many of us are suffering from sleep deprivation and its various accompanying side effects, which include bad dreams and insomnia. For longtime device executives who have been through the regulatory wars, the current discussions about possible nominees to key health positions in the Biden Administration are making this situation worse by causing nightmares and keeping them awake at night worrying about a return to the days of yore. I’m talking, of course, about the appointment of David Kessler, MD, as co-chair of the COVID-19 advisory board, and speculation that Joshua Sharfstein, MD, is one of the leading candidates to head the FDA. Those suffering from particularly fevered visions have already conjured up a scenario whereby current Acting FDA Commissioner and agency stalwart Janet Woodcock eventually returns to the senior ranks with Kessler returning to his role as commissioner.

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