Acting FDA Chief ruled out as permanent nominee

pharmafile | August 20, 2021 | News story | Medical Communications  

The administration for US President, Joe Biden, has ruled out nominating Janet Woodcock as permanent head of the FDA, it has been reported.

Woodcock, who has served as acting commissioner since Biden took office, has faced firm opposition on Capitol Hill from lawmakers including Democratic Senator Joe Manchin, a key swing vote in the evenly divided chamber, who criticised the agency over the accelerated approval this year of an Alzheimer’s drug, Aduhelm.

Biogen’s Aduhelm has been the focal point of much controversy in recent months, as many believe there was not enough evidence provided by the company that proved its efficacy. In March 2019, late-stage international trials of aducanumab, involving about 3,000 patients, were halted when analysis showed the drug, given as a monthly infusion, was not better at slowing the deterioration of memory and thinking problems than placebo.

The White House hasn’t publicly ruled out Woodcock, but officials have privately concluded that she won’t be the nominee.

White House spokesman, Chris Meagher, declined to comment specifically on Woodcock’s future, but said to Bloomberg: “We have strong acting leadership in place that is playing an important role in our COVID-19 response and beyond, and look forward to sharing a nominee with the requisite expertise and leadership for this job.”

Biden’s administration this week announced that it would begin offering COVID-19 booster shots on September 20, an announcement that was signed by Woodcock but which the administration claims is subject to FDA approval.

Biden has also publicly expressed hope that the FDA will soon approve the Moderna and Pfizer vaccines, which have been used widely domestically. He is urging approval because he believes it will ease vaccine hesitancy in the US and also give businesses firmer moral and legal footing to require vaccinations of staff, officials familiar with the matter said.

Kat Jenkins 

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