Alzheimer’s drug approval debacle deepens FDA scrutiny

Adam Cancryn and Sarah Owermohle, Politico: June 11, 2021

BIDEN’s FDA DILEMMA DEEPENS — Capitol Hill opposition to acting FDA Commissioner Janet Woodcock’s candidacy for the permanent job is hardening in the wake of the agency’s approval of a new Alzheimer’s drug known as aducanumab, your hosts report with Lauren Gardner.

The decision has outraged health experts, who point to the thin evidence for the drug’s effectiveness and its whopping $56,000-a-year price tag; already, three members of the FDA’s expert advisory panel have resigned in protest. And it has furthered suspicions among some Democrats that Woodcock remains too close to the industry that, as FDA’s acting head, she’s supposed to regulate.

On Thursday, Sen. Catherine Cortez Masto (D-Nev.) declared that she didn’t trust Woodcock’s judgment and wouldn’t back her to run the FDA permanently. Fellow Democratic Sen. Ed Markey of Massachusetts said he had “deep reservations” about her, and Sen. Elizabeth Warren of Massachusetts said she’d want to “see who else” is in the running before supporting Woodcock.

A handful of others — chief among them swing-vote Sen. Joe Manchin (D-W.Va.) — had previously harbored concerns over Woodcock’s track record on regulating opioids.


The administration has also found few viable alternative candidates. While Obama-era FDA official Michelle McMurry-Heath was vetted for the job, her current role as head of drug industry group BIO presents its own issues.

Still, tapping Woodcock now risks antagonizing a growing contingent of Senate Democrats at a time when Biden is trying to marshal support for his ambitious first-year agenda. “They don’t need Democrats to vote,” National Center for Health Research President Diana Zuckerman said, “they just need Democrats not to be really angry.”

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