- Leading climate activist released from Vietnam jail
- Ethiopians struggle with bitter pill of currency reform
- Sri Lanka votes in first poll since economic collapse
- Feminist author warns of abortion disaster if Trump wins US election
- US city of Flint still reeling from water crisis, 10 years on
- Arsenal's mean defence faces acid test to shut out Man City again
- Late surge lifts Thailand's Jeeno to LPGA Queen City lead
- DeChambeau says PGA's Ryder Cup decision 'just the start'
- Alcaraz defeated on Laver Cup debut
- Postecoglou embraces 'struggle' to make Spurs a success
- Nice hand 'ashamed' Saint-Etienne 8-0 Ligue 1 mauling
- Boeing CEO says ending strike 'a top priority'
- Stock markets mostly fall after Fed-fueled rally
- Harris slams Trump for hypocrisy on abortion as US starts voting
- Academy to host first overseas ceremony to honor young filmmakers
- No doctor necessary: US okays nasal spray flu vaccine for self-use
- Gurbaz, birthday boy Rashid lead Afghanistan to 177-run rout of South Africa
- Former delivery man Baldwin leads star names at PGA Championship
- Trump shooting: Secret Service admits complacency
- Can an ambitious Milei make Argentina an AI giant?
- Haiti, its suffering growing, in 'race against time': UN expert
- Ibrahim Aqil, the Hezbollah elite unit commander wanted by the US
- Chinese forward Cui signs NBA contract with Brooklyn Nets
- US Fed dissenter calls for 'measured' pace of rate cuts
- Guardiola tells players to lead change over workload as Kompany demands cap on games
- Norway limits wild salmon fishing as stocks hit new lows
- Top Hezbollah commander killed in Israeli strike on Beirut
- Rotterdam fatal knife attacker suspected of 'terrorist motive'
- First early votes cast in knife-edge US presidential election
- Top-ranked Swiatek out of Beijing due to 'personal matters'
- Hard-right Reform UK looks to the future after vote success
- Embiid agrees to NBA contract extension with 76ers
- Joshua aims to complete road to redemption in Dubois bout
- World champion Bagnaia sets pace with lap record at Misano
- Biden says 'working' to get people back to homes on Israel-Lebanon border
- Pope criticises Argentina's crackdown on protesters
- Court limits screenings of videos in France mass rape case
- Gurbaz century takes Afghanistan to 311-4 in 2nd ODI
- Central banks face 'difficult balancing act': IMF chief
- McLaren's Norris sets Singapore pace as struggling Verstappen 15th
- Guardiola tells players to lead change over workload fears
- Paris Olympics sports equipment moves to new homes
- 'Happy' Kinghorn relishing life at Toulouse
- Norris sets Singapore pace as Verstappen only 15th
- 8 dead in Israeli strike, source says Hezbollah commander killed
- Germany to bid to host women's Euro 2029
- Portugal brings deadly forest fires under control
- Postecoglou defends Solanke after slow start to Spurs career
- US nuclear plant Three Mile Island to reopen to power Microsoft
- Arteta urges Arsenal to take next step in Man City showdown
US congressional report slams FDA approval of Alzheimer's drug
The US Food and Drug Administration's approval process for a controversial drug used to treat Alzheimer's was "rife with irregularities," a congressional report said Thursday.
An 18-month investigation into the FDA's green-lighting of the drug, Aduhelm, also criticized its manufacturer, biotechnology company Biogen.
The Cambridge, Massachusetts-based Biogen set an "unjustifiably high price" for Aduhelm of $56,000 a year to "make history" with the first drug approved in decades to treat Alzheimer's, the report said.
Aduhelm received "accelerated approval" from the FDA in June despite the fact that an independent panel advising the US drug regulator had found insufficient evidence of its benefit and some experts had raised concerns about inconsistency in the drug's clinical data.
At least three of the 11-member independent committee that voted unanimously against recommending the drug to the FDA subsequently resigned.
According to the congressional investigators, the FDA "considered Aduhelm under the traditional approval pathway used for most drugs for nine months, before abruptly changing course and granting approval under the accelerated approval pathway after a three-week review period."
They found that FDA interactions with Biogen were "atypical" and included a failure to properly document contacts between agency staff and the drug maker.
The FDA and Biogen had also "inappropriately collaborated" on a joint briefing document for a key advisory committee.
"FDA's approval process was rife with irregularities," the report said.
As for Biogen, the report said the company "viewed Aduhelm as an unprecedented financial opportunity -- estimating a potential peak revenue of $18 billion per year."
It quoted a September 2020 presentation to the Biogen board as saying: "Our ambition is to make history" and to "establish Aduhelm as one of the top pharmaceutical launches of all time."
- 'Wake-up call' -
Carolyn Maloney, chairwoman of the House Oversight and Reform Committee, said she hoped the report's findings "are a wake-up call for FDA to reform its practices."
Frank Pallone, chairman of the House Energy and Commerce Committee, said the report "documents the atypical FDA review process and corporate greed that preceded FDA's controversial decision to grant accelerated approval to Aduhelm."
"While we all support the search for new cures and treatments to address devastating diseases like Alzheimer's, we must ensure that expediency does not take precedence over protocols," Pallone said. "Patient safety and drug efficacy must remain at the core of our nation's pharmaceutical regulatory review process."
In a statement, the FDA said it "remains committed to the integrity of our drug approval process, which includes ensuring that safe and effective new treatment options are available to the millions of people with Alzheimer's disease."
Biogen said it "stands by the integrity of the actions we have taken."
"Biogen has been committed to researching and developing treatments for Alzheimer's disease for more than a decade," the company said.
"We have been focused relentlessly on innovation to address this global health challenge, and have adapted to both successes and setbacks."
Y.Nakamura--AMWN