fda officials said there wasnt enough evidence to approve biogen alzheimers drug aducanumab though some of its own senior officials said there was little evidence of benefit for patients the fda nonetheless greenlighted biogens aduhelm or aducanumabcreditandrew kellyreuterspublished july 19 2021updated oct 20 2021two months before the food and drug administrations deadline to decide whether to approve biogens controversial alzheimers drug aducanumab a council of senior agency officials resoundingly agreed that there wasnt enough evidence it workedthe council a group of 15 officials who review complex issues concluded that another clinical trial was necessary before approving the drug otherwise one council member noted approval could result in millions of patients taking aducanumab without any indication of actually receiving any benefit or worse cause harm according to minutes of the meeting obtained by the new york timesit is critical that the decision be made from a place of certainty the minutes saidthe session whose details have not been reported before represented at least the third time that proponents of approving aducanumab in the fda had received a clear message that the evidence did not convincingly show the drug could slow cognitive declineon june 7 the fda greenlighted the drug anyway a decision that has been met with scathing rebuke from many alzheimers experts and other scientists and calls for investigations into how the agency approved a treatment that has little evidence it helps patientshow and why the fda went ahead and approved the drug an intravenous infusion marketed as aduhelm that the company has since priced at 56000 a year has become the subject of intense scrutiny two congressional committees are investigating the approval and the price much is still unknown but an examination by the times has found that the process leading to approval took several unusual turns including a decision for the fda to work far more closely with biogen than is typical in a regulatory reviewallegations about the collaboration prompted the fda to conduct an internal inquiry after a consumer advocacy group called for an inspector generals investigation according to documents reviewed by the times the agency has not disclosed the inquirythough the decision was considered one of the agencys most consequential and controversial in years its leader dr janet woodcock the acting commissioner was not involved in the deliberations and left the final ruling to the head of the center responsible for drug applications the agency confirmedimagecredital dragobloombergin written responses to questions from the times the fda defended its decision to approve the drug the first for alzheimers in 18 yearsthe agency did not lower its standards the fda said adding and at no time considered doing sothe decision the agency said was informed by science medicine policy and judgment in accordance with applicable legal and regulatory standardsin written answers to questions biogen said biogen stands 100 percent behind aduhelm and the clinical data that supported its approvalfacing mounting pressure dr woodcock recently called for an inspector general to investigate the agencys approval process dr woodcock has