Controversial Alzheimer's drug approval ignites FDA reform debate – Axios

The FDA's conditional approval of a controversial Alzheimer's drug last year has sparked heightened scrutiny and an attempted overhaul of a popular regulatory pathway used to fast-track cancer drugs and certain other treatments.
Why it matters: Accelerated approval allows patients to access new drugs deemed to meet unfilled needs much faster than if the drug went through the regular approval process. But critics say that more needs to be done to prove these drugs actually work in the real world, which could have big implications for the pharmaceutical industry.
State of play: Last year, 14 of the 50 new drugs approved by the FDA — including Biogen's Alzheimer's drug, Aduhelm — went through the accelerated approval pathway.
The big picture: Although most experts and policymakers laud the pathway as a way to deliver lifesaving medicines to patients in a more timely manner, Aduhelm's approval has raised questions about whether the program is being misused.
Driving the news: The powerful House Energy and Commerce Committee is considering legislation sponsored by Chairman Frank Pallone that would reform that pathway as part of a larger medical innovation package.
In a letter replying to Wyden's concerns about accelerated approval, recently-confirmed FDA commissioner Robert Califf said that ensuring follow-up studies are done in a timely manner will be a "high priority."
What they're saying: In written testimony to the E&C committee last week, a PhRMA official said the accelerated approval pathway "is a critical tool for patients and regulators, and the biopharmaceutical industry continues to support the pathway in its current form."
The other side: Some critics are more cynical about the industry's support of the status quo.


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