Gottlieb's quick goodbye triggers investor panic, biopharma bewilderment and at least one good riddance

When FDA Commissioner Scott Gottlieb got his job, critics called him a shill and industry types figured they'd gained a friend in the most important drug regulatory agency in the world. It didn't turn out quite that way.

Gottlieb was biopharma-friendly—to the point where the Nasdaq biotech index plummeted at the news of his departure—but he also made a few moves companies didn't particularly like. Speeding up generics, for instance, and decrying the games branded drugmakers play to keep copycats from hitting the market.

Now, he'll be gone within a month, with no successor yet named—even on an interim basis. Biotech investors are obviously panicking, and biotech and pharma companies face an uncharted regulatory landscape, with no idea which Gottlieb initiatives will survive his exit. But some agency critics are quite happy to see Gottlieb go.

"Good riddance," said Public Citizen, for instance.

As for journalists, Gottlieb's resignation portends a slimmer inbox—he typically dispatched at least one statement each day—and far fewer public appearances to follow. Not to mention his blog posts and regular tweets.

Plenty of people are talking about his shocker of a resignation and predicting what's next. Here's what we're hearing from industry types, biotech and pharma analysts, lawmakers, patient advocates and general D.C. prognosticators.

Biopharma worries

The sentiment across the biotech world is quite consistent: They're not ready to let Gottlieb go. After all, he streamlined the drug approval process, and it was under him that the FDA waved through a record-breaking number of new drugs in 2018, and has shown support—and in some controversial cases, tolerance—for drug innovation.

"It's a damn shame," wrote biotech entrepreneur Michael Gilman in a Twitter post. Gilman was previously a senior VP at Biogen, and is now chairman and CEO of Arrakis Therapeutics, and CEO of Obsidian Therapeutics.

Gilman wasn't alone. Biopharma shares were already sinking, just a couple of hours after the news broke, as Wells Fargo analyst David Maris pointed out in a Tuesday note.

Gottlieb's "short tenure has been marked by great progress in drug approvals and changes to support lowering the cost of medications," Maris pointed out.

Brad Loncar, CEO of Loncar Investments and longtime biotech investor, also noted the sharp decline in biotech stocks following the news. As he sees it, the role of FDA commissioner comes with a heavy responsibility, "especially these days with incredible new technologies like cell therapy, gene therapy, and others," he tweeted. And these novel platforms requires "a good partner at FDA to make sure they are developed efficiently and safely."

Judging by the regretful goodbye from the Biotechnology Innovation Organization (BIO), the biotech industry felt it had a decent partner. 

"Dr. Gottlieb is a smart, passionate, and impactful leader who worked tirelessly to protect and promote the health of Americans nationwide," said BIO President and CEO Jim Greenwood in a statement. "I’m sorry to see him go and wish him the best in his future endeavors."

Alnylam CEO John Maraganore, who is also chair of BIO, also praised the "many innovative Rx" Gottlieb's FDA had approved. "We’ll miss Scott but fully expect FDA’s support of innovation to continue," he wrote on Twitter Tuesday. Under Gottlieb's rein, Alnylam got FDA approval for Onpattro, the first RNA interference (RNAi) therapy, after a slew of favorable treatments, including "breakthrough" and orphan drug designations, as well as priority review.

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Gottlieb was markedly scandal-free in an administration marked by high-profile scandals, as one former White House official told Politico. 

"He was able to do something very rare: He never got embroiled in a scandal, never got labeled with a toxic administration brush and had a great relationship with the president all at the same time," the official said.

Ian Tzeng, managing director at L.E.K. Consulting's life sciences practice in Boston, made a similar, if broader point. 

"While not without controversial decisions, he has been relatively free of scandal or personal controversy, and was broadly accepted as practical and non-partisan in his approach," Tzeng said in an emailed interview with FiercePharma.

Overall, Gottlieb was, "an effective pragmatist," Tzeng said. He tightened regulations in some areas such as vaping, put forth initiatives to help drive access to generics and biosimilars, and established more clarity on requirements around biosimilars, gene and cell therapies, Tzeng said.

Among those pragmatic moves? Pushing to speed up generics in spite of potential pushback from branded drugmakers. He called companies on pay-for-delay deals and withholding samples from potential generic rivals, among other things.

"Dr. Gottlieb used his bully pulpit to speak out early and forcefully about brand drug companies withholding samples needed by generic drug makers, about rebate traps and other anti-competitive abuses in the pharmaceutical supply chain," Allen Goldberg, an SVP at the Association of Accessible Medicines, said in a statement.

And in Gottlieb's own words: "One of the barriers to competition that concerns me the most is when companies game the system by taking advantage of certain rules and laws," he said last year, as quoted by NPR. "They exploit loopholes in our system to delay generic entry. In these ways, they extend a drug's monopoly beyond what Congress intended."

Gottlieb also forged relationships with Silicon Valley, CNBC noted, and was open to big new ideas in technology, if somewhat measured in acting on them. "He struck me as both smart and thoughtful," ex-Apple health official Robin Goldstein told the news service. He was "deeply aware of the risks inherent in trying to bring change to the FDA, where lives are at stake, and yet willing to explore innovation originating from Silicon Valley in an effort to begin to reimagine the future of health care and medicine," she said.

The VC community agreed. "Scott did a lot culturally to make the agency easier to work with," said Bob Kocher, a partner at venture capital firm Venrock, investing in health-technology. "I think he'll be missed by many in the tech industry, including the start-ups."

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