Don't expect an accelerated review of the FDA's accelerated approval pathway.
As it goes with the federal government, the Office of the Inspector General said Wednesday it will review the FDA's accelerated approval pathway following a bevy of concerns regarding the agency's controversial green light for Biogen's Alzheimer's disease drug Aduhelm.
Aduhelm was approved by the FDA through the accelerated pathway based on data that suggested the therapy can alter a biomaker that is known to be involved in the devastating neurological disease. The drug has yet to show in clinical testing that it actually improves symptoms of Alzheimer's disease in patients.
The accelerated review pathway allows the FDA to approve drugs for serious conditions that fill an unmet medical need based on data for a surrogate endpoint, which means some sort of marker that is thought to predict a clinical benefit.
The decision has caused a chorus of criticism and fierce debate. On one hand, Alzheimer's patients, their caregivers and physicians wanted a shot—even if the drug is unproven—at halting decline before it's too late. But other doctors are refusing to prescribe the therapy and some have said the FDA's actions have eroded confidence in the regulatory authority.
Other companies have rushed to revive Alzheimer's drugs that have not performed especially well in clinical trials now that the FDA has signaled it's open to approving therapies in this way.
Acting FDA Commissioner Janet Woodcock, M.D., asked the OIG last month to launch an investigation into her own agency's approval of the drug because of concerns regarding relations between regulatory officials and Biogen prior to the June nod.
Woodcock's request came after a report that Biogen executives met with the FDA's neuroscience director Billy Dunn, M.D., and other agency big wigs as early as 2019 to discuss the drug's route to victory.
Now, the OIG has agreed to "assess how the FDA implements the accelerated approval pathway." The watch dog was spurred to act due to the scientific disputes within the FDA, an advisory's panel's rejection of the drug—and the resignation of three members after the approval—and other allegations.
But the investigation won't be swift. The OIG said the review, which could result in multiple reports, might not be issued until 2023. Meanwhile, Eli Lilly is planning to seek an accelerated approval for another Alzheimer's therapy, donanemab, by the end of the year.
The federal agency will dig into the FDA's interactions with outside parties, review the regulator's relevant policies and procedures and determine whether they have been in compliance. Upon its findings, OIG will make recommendations based on a sample of drugs that have been cleared under the accelerated pathway. Aduhelm will be one of those drugs taken into consideration.
"We will not assess the scientific appropriateness of the FDA's approval of any of the drugs under review," OIG said.
For its part, the FDA doesn't want the general public, the scientific community or those in the industry to lose trust in its approvals.
“We believe this review and assessment will help ensure continued confidence in the integrity of FDA’s regulatory processes and decision-making,” Woodcock said in a tweet announcing her request for an investigation last month.