WASHINGTON — It’s the end of an era for the Food and Drug Administration’s longtime drug chief, but she’s drawn the battle plans for the agency’s next chapter.
Janet Woodcock joined the FDA’s biologics division in 1986 but soon moved to the drug side, where over nearly three decades, she oversaw hundreds of reviews, new and evolving classes of therapies and several clashes with Congress and patient advocates. In recent years, she also warded off attacks on the agency’s decisionmaking during the Covid-19 pandemic, particularly when the agency veteran took the acting commissioner role during President Biden’s long search for a permanent leader, and took charge of a vast reorganization plan sparked by the baby formula crisis.
Some of those efforts still hang in the balance as she departs this week. Critics argue that under her oversight, the drug division worked too closely with pharmaceutical companies to give broad approvals to new medicines like Biogen’s Aduhelm or so-called accelerated approval to controversial therapies like Sarepta’s Duchenne muscular dystrophy medicine Exondys 51, which is still in the midst of post-marketing studies to prove its effectiveness.