The Congressional report on the FDA’s approval of Aduhelm makes some good points. As regulatory science advances, so too must the FDA’s administrative procedures.
But this report mustn’t be seen as an excuse for the agency to hew to a 20th century view of drug development and review. The FDA and the industries it regulates must work together to facilitate innovation that results in new and important medical technologies like Aduhelm and other medicines currently in the pipeline for Alzheimer’s disease and other serious and life-threatening conditions.
Recognizing the clinical value of incremental innovation has always been part of the FDA’s mission, and it is more important now than ever. The FDA must be both a regulator of, and colleague with, drug developers. That’s a difficult, urgent, and imperative task, and going backward to an outdated standard isn’t an option.
There are many issues regarding the regulation of drug development, many opinions on it, and many paths forward. To point the way, I’ve got — with apologies to Gilbert & Sullivan — a little list (sung to the tune of “I’ve Got a Little List” from “The Mikado”).
As someday it might happen that a victim must be found
I’ve got a little list
I’ve got a little list
Of FDA offenders who believe it’s just and sound
On innovation to desist
I know you’ve got the gist.
There’s the dour divisional biostat
Who doesn’t like A.I.
And wouldn’t know a signal
If it poked him in the eye.
And then there’s the reviewer
Who really doesn’t have the sense
To open up her mind
To useful Real-World Evidence.
And side-lined middle management
Who feel their opinions have been dissed
And can’t wait to rat to Congress
With loud voices and raised fist.
The sages of the status quo
Who wish Woodcock would go away
So they could turn the clock back
To the “good old-fashioned way.”
Congress might reward them
And the folks at ICER too
But really what should happen
Is they all should bid adieu.
Their efforts against new approaches
To innovation will persist
And in the wake of progress
They’ll just get increasing-aly pissed
Perhaps they should retire
Or be peremptorily dismissed.
And they’ll none of ’em be missed —
They’ll none of ’em be missed!
Peter J. Pitts (a tenor) is a former FDA associate commissioner, president of the Center for Medicine in the Public Interest, a visiting professor at the University of Paris School of Medicine, and a life-long Gilbert & Sullivan fan. You can hear the author’s rendition of the operetta here.
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