US Senator Joe Manchin calls for a new FDA Commissioner to replace current (acting) one who “has repeatedly ignored public health concerns and shown a dereliction of duty” over opioids and aducanumab

Key Demo­c­rat Manchin Bash­es FDA Leader on Alzheimer’s Approval (Bloomberg):

Sen­a­tor Joe Manchin, a mod­er­ate Demo­c­rat con­sid­ered a cru­cial vote with­in the party’s slim Sen­ate major­i­ty, said Janet Wood­cock, the tem­po­rary head of the Food and Drug Admin­is­tra­tion, should be quick­ly replaced with a per­ma­nent leader.

Manchin blast­ed an FDA deci­sion to approve the con­tro­ver­sial Alzheimer’s ther­a­py Aduhelm despite con­flict­ing evi­dence that the Bio­gen Inc. drug works and an over­whelm­ing­ly neg­a­tive vote against the ther­a­py by agency advis­ers. The FDA rul­ing led three mem­bers of that pan­el to quit in protest…

Manchin urged U.S. Pres­i­dent Joe Biden to nom­i­nate “accept­able per­ma­nent lead­er­ship to ensure Amer­i­cans are pro­tect­ed from harm­ful drugs and that sci­en­tif­ic rec­om­men­da­tions are con­sid­ered when approv­ing new med­ica­tions.” … Manchin wrote Biden a let­ter ear­li­er this year rip­ping into the agency for its “long track record approv­ing dan­ger­ous opi­oids with­out con­sid­er­ing pub­lic health.” On Thurs­day, he wrote that Wood­cock, who has been at the FDA for more than 30 years,“ has been there for all of it.”

Senator Manchin’s Letter to President Biden regarding the FDA:

Read the let­ter HERE (opens PDF)

I write today con­cern­ing the lack of per­ma­nent lead­er­ship at the Food and Drug Admin­is­tra­tion (FDA), and the con­tin­ued tenure of Dr. Janet Wood­cock as inter­im com­mis­sion­er. Just last week, the FDA grant­ed approval for Aduhelm (adu­canum­ab), a treat­ment for Alzheimer’s, despite its advi­so­ry pan­el vot­ing near­ly unan­i­mous­ly against its approval, with no pan­el mem­ber vot­ing in favor of approval…

In 2020, over 90,000 Amer­i­cans died from drug relat­ed over­dos­es, which is the high­est year of over­dose deaths ever record­ed, with over half of those like­ly involv­ing an opi­oid or syn­thet­ic opi­oid. This epi­dem­ic is head­ed in the wrong direc­tion. The FDA has played a crit­i­cal role in this over­dose epi­dem­ic by over­see­ing con­tin­u­ous approvals of stronger and more addic­tive opi­oids since the ini­tial approval of Oxy­Con­tin in 1995 – and Dr. Wood­cock has been there for all of it. Dr. Wood­cock has repeat­ed­ly ignored pub­lic health con­cerns and shown a dere­lic­tion of duty by not work­ing to end this epi­dem­ic. It is bla­tant­ly clear that we must do more to address the drug epi­dem­ic that is impact­ing every American…

Almost five months into your Admin­is­tra­tion, we still lack accept­able per­ma­nent lead­er­ship, mak­ing this one of the longest delays in almost 100 years for a new Pres­i­dent to nom­i­nate a com­mis­sion­er. While indus­try has ben­e­fit­ed from the sta­tus quo over the last 35 years of Dr. Woodcock’s tenure at the FDA, the peo­ple, patients and fam­i­lies suf­fer­ing from the opi­oid epi­dem­ic have not. We need urgency as the world emerges from the COVID-19 pan­dem­ic. You need to nom­i­nate a com­mis­sion­er suit­ed to address our pub­lic health chal­lenges imme­di­ate­ly, to set your agen­da at this cru­cial agency for your first year, and give the Sen­ate time to con­sid­er your nominee.

News in Context:

• First, do no harm? Six rea­sons to approach anti-amy­loid drug Aduhelm cau­tious­ly, if at all
• Grow­ing back­lash against the FDA approval of unproven Alzheimer’s treat­ment Aduhelm, by Biogen
• A crit­i­cal appraisal of amy­loid-B-tar­get­ing ther­a­pies for Alzheimer disease