FDA, Surveys

Biopharma execs give Scott Gottlieb’s nomination for FDA commish (almost) a standing O in Endpoints poll

A big majority of biopharma executives overall are clearly enthusiastic about President Trump’s decision to nominate Scott Gottlieb as the next FDA commissioner.

In our snap poll over the weekend Gottlieb picked up 87% support among the 580 qualified subscribers who voted on the decision, with 504 approving the choice against 76 who largely hated it.

Keep in mind, so far the Trump administration has earned a solid negative rating in the drug development business as execs in overwhelmingly Democratic regions registered their disdain for his travel ban, rejected the notion of gutting regulations and expressed fears that a new approach on H-1B visas could make it much harder to recruit top talent from beyond US borders. Gottlieb, though, looks like a breath of fresh air in an industry that’s been feeling badly choked in Washington, DC for the past two months.

“Absolutely!” cheered Alnylam CEO John Maraganore when he was asked whether he approved of the nomination. “First good thing Trump has done.”

The full spectrum of pro-Gottlieb sentiment ran the gamut from what could be described as the best of a bad lot to a big thumb’s up for a physician who has experience at the FDA and a deep understanding of the development and review process, which he will now push into high gear.

You could practically hear the sigh of relief that followed deep-seated fears that Trump might choose a Libertarian like Jim O’Neill, who has sounded ready to drop the bar on new approvals about as low as it can get.

“I think it is a relief that Gottlieb is experienced in regulatory matters and at the FDA, understands that a strong FDA is the best way to get medicines to patients and also supports using the best new science to improve the FDA’s approval process,” said Basil Dahiyat, the CEO of antibody engineering company Xencor. “Rational and rigorous physicians and doctors who want to try new ideas are what industry needs at the FDA. Appointing somebody who wants to make the FDA better, rather than impose totally unfounded ideology to gut good regulation like some of the other candidates floated, is promising.  Strange days indeed that the alternative was even really considered.”

“Understands agency and industry needs,” noted one response. “The one rational choice amongst the candidates mentioned.”

A few other comments from the pro-Gottlieb side:

“He seems like a reasonable candidate, willing to listen, and I see his ties to industry as a benefit, in terms of his understanding of the business.”

“He’s experienced and will bring a thoughtful approach to the complex challenges of running FDA. This is not a job for a lightweight.”

Steve Holtzman, the CEO of Decibel Therapeutics, put it this way:

“While I am in many, many ways ideologically at the other end of the spectrum from Scott, I support his appointment. He believes in science-based regulation–addressing BOTH efficacy and safety–and embraces scientific advances that can, with good justification and without imperiling patients, make clinical trials more efficient. I also think that concerns about conflict of interest, because of his work with the biopharmaceutical industry, are ill-founded. The blanket application of this type of logic leads to calls to exclude from FDA Advisory Panels those most qualified because those same individuals, for the very same reason of their expertise, are sought by industry as advisors. –While no doubt true that many will sell their souls and reputations for a buck, it is also the case that such an accusation, made against a specific individual without any evidence, can tell us more about the accuser than the accused.”

Another simply said: “Pro-industry” in giving a thumb’s up.

But you could find the exact same remark repeated among the 13% of our subscribers who ended up shaking their heads over the nomination.

“Too wed to industry,” noted one negative response to Gottlieb.

That industry experience that Gottlieb has that so many found reassuring looked like a serious conflict of interest to the ‘no’ voters. And besides, in some eyes Trump – who clearly alarmed the industry with vows to deregulate drug development — can’t do anything right.

“Too close with the industry & wants to reduce or eliminate the regulations that have worked to keep the US safe.”

“His ardor for deregulation could be harmful to consumers and ultimately the industry. Proposal to centralize review decisions could result in further politicizing approval decisions.”

“Unqualified,” said another.

”Will institute dangerous policy and be beholden to Trump.”

Gottlieb hasn’t been shy about making concrete suggestions for a new and improved FDA. As I’ve written, he’s backed a more focused approach on rare disease drugs, publishing complete response letters of rejection and quickly moving complex generics to the market, among other things.

Now he has to start delivering on those promises — or run the risk of severely disappointing an industry whose clear support may have well been the deciding factor behind his nomination.

 

Here’s just a few more comments from subscribers …

 

Yes

Acceleration and simplification of the process and requirements for approval of biosimilars is desperately needed. Publication of CR letters is overdue. Increased use of surrogate endpoints is a potential concern depending on how low the bar would be set. Surrogate endpoints should be agreed upon prior to initiation of studies.


While I am in ideologically at the other end of the spectrum from Scott, I support his appointment. He believes in science-based regulation–addressing BOTH efficacy and safety–and embraces scientific advances that can, with good justification and without imperiling patients, make clinical trials more efficient. I also think that concerns about conflict of interest, because of his work with the biopharmaceutical industry, are ill-founded. The blanket application of this type of logic leads to calls to exclude from FDA Advisory Panels those most qualified because those same individuals, for the very same reason of their expertise, are sought by industry as advisors. While no doubt true that many will sell their souls and reputations for a buck, it is also the case that such an accusation, made against a specific individual without any evidence, can tell us more about the accuser than the accused.


Excellent balance of medical expertise, prior experience and political deftness. Scott will force great change in culture, organization, philosophy and leadership at FDA. He will bring an especially patient-centric focus to the FDA. We are particularly excited about his belief in the need for a separate review division for rare diseases at FDA. Great day for science, medicine and for patients. Not so great a day for FDAers who yearn for rigid, inflexible and non-21st Century drug development.


Doesn’t want to dismantle agency he’s leading.


He has the necessary experience and deep understanding of both the agency and the industry. The changes he has been advocating in his published writings have broad support and were indeed the type of bureaucratic hurdles that needed to be simplified for the greater public good.


Calm persona. Regulatory and medical background. Has shown an understanding of data.


Americans don’t realize it but the phobia that the FDA and NIH staff have about industry inputs and cooperations hurts the process of moving research advances to medicines. For example, drug discovery and clinical trials biomarkers requires much better industry-NIH/FDA cooperations. (Currently, these are handled by the FNIH, consortia, PCORI and the IMI). Legislation that would allow more pooling of NIH/FDA/industry funds is required. A new Biomarker Consortium that can move quickly would be good for medicine, the public, and industry.

No

He believes in de-emphasizing safety in favor of medical innovation. Both are important, but with recent safety setbacks as in the case of Juno, I fear that the safety bar may be set a little low.


On a matter of principle, it is always better to have a watchdog with as much neutrality and separation as possible. You don’t want your watchdog to be your best friend. They’re there to push back and bring the best out of you. Given the choices we had, thank goodness Scott was selected, but that shouldn’t distract us from the fact that when our friends become our oversight, we erode the oversight that does the institution justice. The lasting costs of non-neutral insider checks has been seen time and again through history and across foreign governments where a revolving door feeds corruption and self-serving bureaucracies. Scott’s a great guy. He fundamentally cares about patients. He loves the industry and the FDA with passion. But he should humble himself to his bias and recuse himself. Only thirty years ago, the industry was clamoring about basic FDA rules and now the industry realizes its importance. Thirty years from now, hopefully it’ll be further clear how important it is to make sure whatever checks come, we don’t write them ourselves.


Better than the alternatives but still too deregulatory.