Government watchdog recommends tweaks to FDA accelerated approval program
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening conditions for which there is no alternative treatment. The approval then is contingent upon a confirmatory trial. But the FDA has had difficulty enforcing its post-marketing requirements.
Federal watchdog cites concerns with FDA’s accelerated approval process
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency procedures.
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate (HPC; Makena), which was approved in 2011 to reduce the risk of recurrent preterm birth; and the Duchenne muscular dystrophy treatment eteplirsen (Exondys 51).
Federal watchdog raises some concerns about the FDA’s accelerated approval program
The Office of Inspector General reviewed the FDA’s use of accelerated approval for 24 drugs, ultimately finding issues with the process for three of them.
OIG Recommends Changes in FDA Accelerated Approval After Flagging Concerns With Aduhelm, Other Drugs
The OIG recommended that the FDA define factors that would trigger an application's review by an agency council, which the agency disagreed with.
Watchdog flags flaws in FDA's fast-track drug approvals
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional investigations revealed at least 40. Some meeting summaries were also found to be incomplete, according to Bloomberg .
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pharmaphorum4d
Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go
Here we go again. With Aduhelm largely sidelined, Biogen and Eisai are hoping for a better fortunes with their next Alzheimer's disease therapy lecanemab, which is now fully filed with the FDA.
STAT3d
Pharmalittle: We’re reading about FTC criticizing PBMs, an NIH policy on access to medicines, and more
The FDC released a second highly critical report of PBMs, which may provide further impetus for legislative action to curb ...
BioSpace3d
Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
pharmaphorum7d
Aduhelm and an expensive failure to launch
From the beginning, the approval of its Aduhelm (aducanumab) treatment was met with controversy – over the interactions with the FDA, and the advisor committee’s vote against the treatment ...