Sunday, 25 May 2025
America Age
  • Trending
  • World
  • Politics
  • Opinion
  • Business
    • Economy
    • Real Estate
    • Money
    • Crypto & NFTs
  • Tech
  • Lifestyle
    • Lifestyle
    • Food
    • Travel
    • Fashion / Beauty
    • Art & Books
    • Culture
  • Health
  • Sports
  • Entertainment
Font ResizerAa
America AgeAmerica Age
Search
  • Trending
  • World
  • Politics
  • Opinion
  • Business
    • Economy
    • Real Estate
    • Money
    • Crypto & NFTs
  • Tech
  • Lifestyle
    • Lifestyle
    • Food
    • Travel
    • Fashion / Beauty
    • Art & Books
    • Culture
  • Health
  • Sports
  • Entertainment
Have an existing account? Sign In
Follow US
© 2024 America Age. All Rights Reserved.
America Age > Blog > World > Probe: Alzheimer’s drug approval ‘rife with irregularities’
World

Probe: Alzheimer’s drug approval ‘rife with irregularities’

Enspirers | Editorial Board
Share
Probe: Alzheimer’s drug approval ‘rife with irregularities’
SHARE

WASHINGTON (AP) — The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.”

The 18-month investigation by two House committees detailed “atypical collaboration” between FDA regulators and a company it’s supposed to oversee — Aduhelm manufacturer Biogen. The probe also cited Biogen documents saying the company intended to “make history” when it set what investigators called an “unjustifiably high” initial price of $56,000 a year for the drug.

The criticism comes as the FDA is expected to decide whether to approve another new Alzheimer’s drug in January. Thursday’s report urged the agency to “take swift action” to ensure that any future Alzheimer’s approvals aren’t met with “the same doubts about the integrity of FDA’s review.”

The FDA and Biogen issued statements Thursday defending the Aduhelm approval process.

In 2021, the FDA overruled its own independent scientific advisers when it approved Aduhelm even though research studies failed to prove it really helped patients. Biogen had halted two studies after disappointing results suggested the drug wasn’t slowing Alzheimer’s inevitable worsening — only to later contend that a new analysis of one study showed higher doses offered an incremental benefit.

The FDA argued the drug’s ability to reduce a hallmark of Alzheimer’s, a buildup of plaque in the brain, suggested it was likely to slow the disease. Backlash was immediate as three FDA advisers resigned in protest and the agency’s then-acting chief called for an internal investigation. Eventually Medicare refused to pay for the drug — even after the yearly price was dropped to $28,000 — unless patients enrolled in clinical trials to prove if it indeed slowed cognitive decline.

Thursday’s report said FDA and Biogen engaged in an unusually high volume of phone calls, meetings and emails, some of them not properly documented. In addition, the regulators and company spent months working together to prepare a briefing document for FDA’s advisers that didn’t adequately represent substantial disagreement within the FDA about how to handle Aduhelm, the report said.

The investigators recommended that FDA take steps to restore trust in the approval process that include properly documenting interactions with drugmakers. They also urged manufacturers to take into account advice from patient groups and other outside experts on fair drug pricing.

In a statement Thursday, FDA said the Aduhelm decision “was based on our scientific evaluation of the data” and that the agency’s own internal review found its interactions with Biogen were appropriate. But it said it plans to update guidance on Alzheimer’s drug development and will review the investigation’s findings.

In its own statement, Biogen said: “Alzheimer’s is a highly complex disease and we have learned from the development and launch of Aduhelm” but that it “stands by the integrity of the actions we have taken.”

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

Share This Article
Twitter Email Copy Link Print
Previous Article California deputy killed by driver, suspect dies in shootout California deputy killed by driver, suspect dies in shootout
Next Article Steven Tyler Accused of Sexual Assault of a Minor in New Lawsuit Over a Decades-Old Claim Steven Tyler Accused of Sexual Assault of a Minor in New Lawsuit Over a Decades-Old Claim

Your Trusted Source for Accurate and Timely Updates!

Our commitment to accuracy, impartiality, and delivering breaking news as it happens has earned us the trust of a vast audience. Stay ahead with real-time updates on the latest events, trends.
FacebookLike
TwitterFollow
InstagramFollow
LinkedInFollow
MediumFollow
QuoraFollow
- Advertisement -
Ad image

Popular Posts

‘Every day you’re hopeless’: Haitians eye foreign help warily as gangs, cholera outbreak take toll

PORT OF SPAIN, Trinidad -- As Haiti continues to grapple with gang violence, inflation and…

By Enspirers | Editorial Board

John Mayer Announces Final Dead & Company Tour

Dead & Company‘s upcoming summer tour will be their final run.John Mayer, who has been…

By Enspirers | Editorial Board

Regulation Professor Warns New Types attempt to get round NAR settlement

In a brand new report, College of Buffalo contracts legislation professor Tanya Monestier particulars methods…

By Enspirers | Editorial Board

Six children in same Uganda family catch Ebola

The outbreak began in Mubende, central Uganda, over a month agoSix children in the same…

By Enspirers | Editorial Board

You Might Also Like

‘A heifer came into the bedroom’: Kevin survived the NSW floods – however his dairy farm won’t
World

‘A heifer came into the bedroom’: Kevin survived the NSW floods – however his dairy farm won’t

By Enspirers | Editorial Board
‘There was panic’: Northland procuring centre locked down after battle allegedly involving ‘rival groups’ and a machete
World

‘There was panic’: Northland procuring centre locked down after battle allegedly involving ‘rival groups’ and a machete

By Enspirers | Editorial Board
Irish pro-Palestine activists embrace ‘Paddystinian’ time period as badge of honour
World

Irish pro-Palestine activists embrace ‘Paddystinian’ time period as badge of honour

By Enspirers | Editorial Board
Littleproud says ‘I don’t care’ about doubtlessly shedding Nationals management as Canavan insists internet zero not settled
World

Littleproud says ‘I don’t care’ about doubtlessly shedding Nationals management as Canavan insists internet zero not settled

By Enspirers | Editorial Board
America Age
Facebook Twitter Youtube

About US


America Age: Your instant connection to breaking stories and live updates. Stay informed with our real-time coverage across politics, tech, entertainment, and more. Your reliable source for 24/7 news.

Company
  • About Us
  • Newsroom Policies & Standards
  • Diversity & Inclusion
  • Careers
  • Media & Community Relations
  • WP Creative Group
  • Accessibility Statement
Contact Us
  • Contact Us
  • Contact Customer Care
  • Advertise
  • Licensing & Syndication
  • Request a Correction
  • Contact the Newsroom
  • Send a News Tip
  • Report a Vulnerability
Terms of Use
  • Digital Products Terms of Sale
  • Terms of Service
  • Privacy Policy
  • Cookie Settings
  • Submissions & Discussion Policy
  • RSS Terms of Service
  • Ad Choices
© 2024 America Age. All Rights Reserved.
Welcome Back!

Sign in to your account

Lost your password?