WASHINGTON — A high-profile, experimental therapy for ALS is teeing up a crucial test of the Food and Drug Administration’s ability to withstand political pressure.
The drug, from Amylyx Pharmaceuticals, has been the subject of an immense pressure campaign from ALS patients and advocacy organizations — one with roots in the broader “right-to-try” movement’s successful efforts to weaken the agency’s ability to limit patients’ access to drugs to treat deadly diseases. ALS advocates charge that the FDA has stubbornly blocked access to therapies that might add even a glimmer of hope to a diagnosis that is otherwise a death sentence — an argument that the FDA has worked hard to counter.