The Aduhelm Operetta: ‘I’ve got a little list’

The Congressional report on the FDA’s approval of Aduhelm makes some good factors. As regulatory science advances, so too should the FDA’s administrative procedures.

However this report mustn’t be seen as an excuse for the company to hew to a twentieth century view of drug growth and overview. The FDA and the industries it regulates should work collectively to facilitate innovation that leads to new and necessary medical applied sciences like Aduhelm and different medicines presently within the pipeline for Alzheimer’s illness and different critical and life-threatening circumstances.

Recognizing the scientific worth of incremental innovation has all the time been a part of the FDA’s mission, and it’s extra necessary now than ever. The FDA have to be each a regulator of, and colleague with, drug builders. That’s a troublesome, pressing, and crucial job, and going backward to an outdated normal isn’t an possibility.

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There are a lot of points concerning the regulation of drug growth, many opinions on it, and plenty of paths ahead. To level the way in which, I’ve acquired — with apologies to Gilbert & Sullivan — a bit of checklist (sung to the tune of “I’ve Received a Little Record” from “The Mikado”).

As sometime it’d occur {that a} sufferer have to be discovered
I’ve acquired a bit of checklist
I’ve acquired a bit of checklist
Of FDA offenders who imagine it’s simply and sound
On innovation to desist
I do know you’ve acquired the gist.

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There’s the dour divisional biostat
Who doesn’t like A.I.
And wouldn’t know a sign
If it poked him within the eye.

After which there’s the reviewer
Who actually doesn’t have the sense
To open up her thoughts
To helpful Actual-World Proof.

And side-lined center administration
Who really feel their opinions have been dissed
And might’t wait to rat to Congress
With loud voices and raised fist.

The sages of the established order
Who want Woodcock would go away
So they may flip the clock again
To the “good old style method.”

Congress would possibly reward them
And the oldsters at ICER too
However actually what ought to occur
Is all of them ought to bid adieu.

Their efforts in opposition to new approaches
To innovation will persist
And within the wake of progress
They’ll simply get increasing-aly pissed
Maybe they need to retire
Or be peremptorily dismissed.

And so they’ll none of ’em be missed —
They’ll none of ’em be missed!

Peter J. Pitts (a tenor) is a former FDA affiliate commissioner, president of the Middle for Medication within the Public Curiosity, a visiting professor on the College of Paris College of Medication, and a life-long Gilbert & Sullivan fan. You may hear the writer’s rendition of the operetta right here.

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