Janet Woodcock Retiring in Early 2024
After 37 years at FDA, second-in-command and principal deputy commissioner Janet Woodcock is retiring early next year. In confirming her departure, FDA commissioner Robert Califf called her a legend for making an “indelible mark on so many of us, and on public health.” Califf said that while no one can fill Woodcock’s shoes, he will announce news about her successor in the near future. Asked about any future plans, Woodcock told FDA Webview: “I have some things I want to do but not a future ‘job.’”
Woodcock spent over two decades as CDER director until the Covid-19 pandemic saw her move to the government’s “Operation Warp Speed” response in early 2020. In this capacity, she supported the development, evaluation, and availability of treatments such as monoclonal antibodies and antiviral drugs for patients with Covid-19.
Woodcock may be best remembered for her efforts over almost 20 years to boost manufacturing technology and quality. Dating back to 2002, Woodcock advocated for the agency’s initiative entitled GMPs for the 21st Century (see earlier story), and after over a decade of disappointments, the effort transitioned into a “culture of quality” under a CDER reorganization in 2013 (see story).
Woodcock’s ending career is also tainted with controversy. In 2016, she overrode a review (see story) on a Sarepta NDA for the Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen). At the time, Woodcock’s interference sparked internal dissent when Office of Drug Evaluation 1 director Ellis Unger challenged her override and brought an appeal before the FDA Scientific Dispute Process Review Board chair and then-acting chief scientist Luciana Borio, who sided with Unger in his argument that the NDA’s data had not met the standard for accelerated approval. The board subsequently asked Califf then in his first term as the agency’s head, to review the scientific merits of the case, and he ruled in favor of Woodcock and the drug's approval.
Unger’s appeal noted he was particularly troubled that the approval could lower the standard for all rare disease drugs. He questioned whether any increase in a surrogate endpoint could be used to support approval for other drugs. “Perhaps granting accelerated approval to drugs that show a mere scintilla of an effect on a surrogate endpoint represents a stroke of brilliance — one that will stimulate investment in the development of drugs for these disorders,” he told Califf.
In a move reminiscent of Woodcock’s interference, CBER director Peter Marks earlier this year overrode his Center’s review team in granting the accelerated approval of Sarepta Therapeutics’ DMD gene therapy Elevidys (see story).