The Food and Drug Administration’s suggested solution comes in response to complaints about the fast approval process and an independent federal investigation into it following the contentious approval of Biogen Inc.’s Aduhelm, a medication for Alzheimer’s disease.
The US health watchdog suggested on Friday that manufacturers of cancer drugs generally undergo more thorough experiments to request speedy approval for their candidates.
The Food and Drug Administration’s proposed recommendation follows criticism for the accelerated approval pathway, as well as an independent federal review into it after the controversial nod for Biogen Inc’s Alzheimer’s treatment Aduhelm.
Expedited approvals allow the agency to bring cures for critical and life-threatening disorders to market faster, but they have come under fire because some drugs have since been found to be useless.