Acting Food and Drug Administration head Janet Woodcock is a leading contender for nomination as permanent commissioner of the agency but faces opposition from Democrats for her ties to the major drug companies responsible for developing highly addictive opioid painkillers.
President Biden has not named his pick to head the agency yet, but Woodcock is a strong candidate and career health regulator. Two key Senate Democrats, Maggie Hassan of New Hampshire and Joe Manchin of West Virginia, have privately signaled resistance to her potential nomination, sources familiar with the discussions told Politico. Her record of helping bring opioids to market has rankled the senators who represent states with some of the highest rates of opioid abuse and overdose.
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Woodcock, 72, first joined the FDA in 1986, where she has held several leadership positions in divisions of the agency concentrated on development of biologics such as vaccines and blood disorder treatments, as well as the review and approval of new pharmaceuticals. She oversaw the approval processes of many prescription opioids, including Purdue Pharma’s drug OxyContin, while she served as director of the FDA’s Center for Drug Evaluation and Research from 1994 to 2005. Her opponents from anti-opioid advocacy groups have argued that Woodcock played an important role in spurring the opioid crisis, which led to more than 70,000 overdose deaths in 2019 alone.
Dozens of patient advocacy groups have thrown their support behind Woodcock, telling Biden earlier this year that her history of overseeing the approval and distribution of innovative new prescription drugs makes her the most qualified choice for the nomination. More than 80 patient groups, such as the Alliance for Aging Research and the Lupus Foundation of America, urged Biden last month to keep her on as commissioner, arguing that her partnership with pharmaceutical companies to approve more specialty drugs for serious illnesses such as cancer has “helped modernize pharmaceutical manufacturing.”
Yet, the endorsement from patient advocacy organizations has not quelled Democratic concerns that Woodcock is too friendly with Big Pharma. Pharmaceutical companies provide significant financial backing for those organizations, having donated more than $116 million to patient advocacy groups in a single year, a 2018 Kaiser Health News analysis concluded.
“The rallying around Ms. Woodcock’s nomination that we’ve seen from Big Pharma should give everyone real pause,” Hassan said to Politico.
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A staffer familiar with talks among Democrats from opioid crisis hot spots said Woodcock is “the most culpable bureaucrat that exists,” suggesting that a confirmation could end up relying heavily on Republicans.