Does biopharma support the Califf nom for FDA? Yeah, whatever
Now that President Joe Biden has drug his heels as long as possible in selecting a new FDA commissioner, we’re set to welcome the new boss — same as the old boss.
Janet Woodcock, whose public legacy may now boil down to the approval of an unproven Alzheimer’s drug and whose industry legacy centers on putting the agency in sync with the largest drug developers, is set to step aside as Robert Califf makes his way back to the helm. And the industry largely appears to think that’s just fine.
We asked our readers what they thought about the move — which Washington insiders believe is largely a slam dunk given the last vote in Califf’s favor. And 58% offered a quick and emphatic thumbs up. True, right at 1 in four were not happy about the move. But with another 18% lined up among the undecideds, it’s clear he won’t face much if any criticism from insiders, who mostly like him fine.
Califf, notes one supporter, “knows what he is doing. FDA is in a good place and does not need reinventing. He will have to avoid Biogen like issues, but that is not hard.”
A key moment in his past experience running the FDA occurred when Califf let Woodcock move ahead with her controversial OK for Sarepta’s still experimental Duchenne MD drug. After delaying the start of its confirmatory trial, Sarepta will need more than 9 years to see through its post-approval study. Biogen also gets 9 years. And no one is looking for the FDA to make things much harder for the average drug developer.
Califf will always look a little lackluster compared to Scott Gottlieb, a dynamic commish who also helped spotlight the revolving door between the FDA and industry by leaping straight to Pfizer’s board. Califf is jumping in from Verily. But he got his academic cred at Duke, and he gets a lot of support for that alone.
— He’s the clear best option among some not-great candidates (aside from Scott Gottlieb, who apparently was not interested in the job).
“We need an FDA head and there isn’t anyone else who seems better,” notes another reader.
Others find that hard to believe.
— This is a critical time in the FDA’s future and it is time for new blood.
“Too closely connected to industry and current government,” writes another in a comment repeatedly echoed among the critics.
That insider knowledge, though, can cut both ways with this crowd.
— Pragmatic leader with an excellent understanding of the clinical development process and a true commitment to innovation for patients that improve patient outcomes.
— Thoughtful, dedicated, great perspective, trained as a clinician and clinical researcher, so he sees the field of therapeutic development from a wonderful perspective. Cares about people and public health, does not view himself as a “regulator”. He has all the right skills to lead FDA back to a trusted position of leadership and public service in these fraught times of public opinion.
But the praise was largely muted:
— Good enough considering the alternatives.
At this point, just making a choice and clearing up any uncertainty will be reassuring to a large segment of industry leaders. And whatever Janet Woodcock does next, her dominant spirit will continue to influence events at the FDA.