The Food and Drug Administration’s stunning decision earlier this month to approve a controversial, first-of-its kind Alzheimer’s treatment called Aduhelm from Biogen took many in the biotech community by surprise. But the political implications for the FDA and the future of its senior leadership, as well the agency’s relationship with the industry it oversees, are still far from clear as President Joe Biden has yet to decide who to nominate as a permanent FDA commissioner.
Congress has had a strange relationship with the FDA in the past few months between the Aduhelm (known generically as aducanumab) approval, hearings over the FDA’s proposed budget, and kudos from lawmakers over the agency’s rapid turnaround on granting emergency authorizations for COVID vaccines.
But the approval of the Alzheimer’s drug, which occurred despite overwhelming opposition by the FDA’s own outside group of independent advisers, may have thrown a wrench into the prospects of Janet Woodcock taking the permanent position. Woodcock is a longtime agency veteran who is currently serving as the acting FDA commissioner and had been rumored to be the frontrunner for the official post.
But her decades-long FDA tenure has seen its fair share of controversial drug approvals over the recommendations of outside advisers, as well as accelerated clearances for treatments that haven’t shown much of a clinical benefit. For instance, the opioid treatment Zohydro, the rare disease drug Exondys 51 and now, Biogen’s Aduhelm, were all met with skepticism by independent experts. And while Woodcock has distanced herself from the Aduhelm decision, declining to send out her own signed release, her critics say those past examples show a pattern.
In a letter to President Biden on June 17, West Virginia Sen. Joe Manchin, a moderate Democrat and one of the most powerful politicians shaping Biden’s agenda in a 50-50 split Senate, outlined a series of grievances against Woodcock and urged the president to choose someone else to fill the permanent role
“While the approval of a drug provides hope for the millions of Alzheimer’s
patients and their families, many scientists have second-guessed the scientific benefit of this approval,” wrote Manchin in his letter to Biden, noting that the Aduhelm approval led to three experts resigning from the FDA advisory committee in protest of the decision. Manchin has also previously criticized Woodcock for not being critical enough of new opioid drugs, which he believes contributed to the painkiller addiction crisis.
But the pressure is mounting on Biden to make up his mind on a permanent FDA head. Particularly because of the ongoing COVID pandemic and the Aduhelm approval, which has raised deep questions about what the agency’s relationship with the pharmaceutical industry should be and how it should decide drugs get approved. For instance, the FDA judges a drug based on safety and efficacy. But as long as a treatment is proven safe, even if it’s not proven effective (and can’t be proven effective for years), is that enough reason to approve a new medicine for a deadly disease?
That’s a question the Senate will have to ponder once Biden names his nominee. But with a razor-thin margin in the Senate and Manchin’s staunch disapproval, a Woodcock nomination would likely have to attract bipartisan support to make it through the Senate.
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