The Congressional report connected the FDA’s support of Aduhelm makes immoderate bully points. As regulatory subject advances, truthful excessively indispensable the FDA’s administrative procedures.
But this study mustn’t beryllium seen arsenic an excuse for the bureau to hew to a 20th period presumption of cause improvement and review. The FDA and the industries it regulates indispensable enactment unneurotic to facilitate innovation that results successful caller and important aesculapian technologies similar Aduhelm and different medicines presently successful the pipeline for Alzheimer’s illness and different superior and life-threatening conditions.
Recognizing the objective worth of incremental innovation has ever been portion of the FDA’s mission, and it is much important present than ever. The FDA indispensable beryllium some a regulator of, and workfellow with, cause developers. That’s a difficult, urgent, and imperative task, and going backward to an outdated modular isn’t an option.
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There are galore issues regarding the regularisation of cause development, galore opinions connected it, and galore paths forward. To constituent the way, I’ve got — with apologies to Gilbert & Sullivan — a small database (sung to the tune of “I’ve Got a Little List” from “The Mikado”).
As someday it mightiness hap that a unfortunate indispensable beryllium found
I’ve got a small list
I’ve got a small list
Of FDA offenders who judge it’s conscionable and sound
On innovation to desist
I cognize you’ve got the gist.
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There’s the dour divisional biostat
Who doesn’t similar A.I.
And wouldn’t cognize a signal
If it poked him successful the eye.
And past there’s the reviewer
Who truly doesn’t person the sense
To unfastened up her mind
To utile Real-World Evidence.
And side-lined mediate management
Who consciousness their opinions person been dissed
And can’t hold to rat to Congress
With large voices and raised fist.
The sages of the presumption quo
Who privation Woodcock would spell away
So they could crook the timepiece back
To the “good old-fashioned way.”
Congress mightiness reward them
And the folks astatine ICER too
But truly what should happen
Is they each should bid adieu.
Their efforts against caller approaches
To innovation volition persist
And successful the aftermath of progress
They’ll conscionable get increasing-aly pissed
Perhaps they should retire
Or beryllium peremptorily dismissed.
And they’ll nary of ’em beryllium missed —
They’ll nary of ’em beryllium missed!
Peter J. Pitts (a tenor) is simply a erstwhile FDA subordinate commissioner, president of the Center for Medicine successful the Public Interest, a visiting prof astatine the University of Paris School of Medicine, and a life-long Gilbert & Sullivan fan. You tin perceive the author’s rendition of the operetta here.
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