Ex-FDA neuro chief Billy Dunn is taking a spin through the revolving door with biopharma — and that’s a problem

It’s been less than three months since the FDA put out word that Billy Dunn had left the agency following a controversial run highlighted by a calamitous decision to approve Biogen’s Alzheimer’s drug, Aduhelm. And he didn’t leave much room for a break.

Bioregnum Opinion Column by John Carroll

On Tuesday night we learned, via press release, that Prothena CEO Gene Kinney had signed him up for a lucrative board post, where no doubt Dunn can play a helpful role in guiding them through the FDA process as they advance their own neuro drugs through the clinic.

Kinney is no fool, any more than Albert Bourla was when he snapped up Scott Gottlieb in a New York minute after Gottlieb left his post as FDA commissioner.

Prothena is big into neuroscience, with its own experimental drugs for Alzheimer’s, ALS and amyloidosis. Having the former head of the FDA’s neuroscience division, who had plenty of say over the way companies — including Prothena — design and execute trials, will illuminate what can be an otherwise murky scene. He knows who’s who and what’s what. And that is tremendously valuable.

Billy Dunn

Having Dunn on the board saves time, improves odds of success, and it’s all perfectly fine with the FDA — where the commissioner these days has plenty of first-hand experience with the revolving door between the agency and the biopharma business. Robert Califf’s passed through it a few times. And it’s well worth the $350,000 (or so) a year Prothena compensates board members, according to its most recent proxy.

The lines between the FDA and the industry blurred long ago. What is supposed to be a public watchdog out to ensure that drugs are safe and effective for the public is staffed by a group of scientists and regulators who know full well that their futures and fortunes often rest with the people and companies they’re supposed to be carefully scrutinizing.

Did Dunn know that any interactions between either himself or the group he managed would influence whether or not he later got high-paying posts like the Prothena board seat?

Dunn was quite frank during the disastrous Biogen adcomm when he told the advisors that the FDA was asking regulators to be helpful to biopharma during the pandemic. It was implied policy. In the process he created precedents at the FDA that are worth billions of dollars to big and little companies, lowering standards on approvals that are now opening up megablockbuster markets.

Mind you, I’m not saying his move to Prothena was a quid pro quo. There’s a word for that, and I have no reason to use it. But are you laughing a bit at me for even asking the question about industry influence? (What a rube!)

It’s been going on for years.

Back in 2016, Vinay Prasad and colleagues published a study in the BMJ that calculated that more than half of the FDA staffers involved in hematology-oncology drug reviews between 2001 and 2010 went on to take industry jobs. Prasad called that “astonishingly high.”

“If you know a major post-employment opportunity is on the other side of the table, you give them the benefit of the doubt,” Prasad told STAT. “You, maybe, make things a little easier on the companies.”

Maybe.

Back when Gottlieb was commissioner, he reneged on a promise he made to lawmakers to make CRLs public. Opening up appropriately redacted CRLs would immediately put a stop to repeat and often open deceptions. We’ve all seen numerous instances where companies have misled investors and industry with their own liberal interpretations of what the FDA was saying, which was only revealed long after the fact. But once in as commissioner, Gottlieb dropped it.

Don’t expect Califf to discuss it much, either.

None of that type of catering to the industry is a direct conflict, but it’s all one more drop of toxicity in the pool of public opinion, where the biopharma industry typically ranks just below the buy-here, pay-here used car industry. The next time you hear politicians breathing fire about drug prices, remember that the FDA’s revolving door helped set the stage for populist anger directed against biopharma.

You’re not working for the people when you know your next job involves networking with industry. And they know it.

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