- March 12, 2019
Gottlieb was biopharma-friendly — to the point where the Nasdaq biotech index plummeted at the news of his departure; however, he also made a few moves companies did not particularly like. Speeding up generics, for instance, and decrying the games branded drugmakers play to keep copycats from hitting the market.
Now, he will 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. However, 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 is next. Here is what we are hearing from industry types, biotech and pharma analysts, lawmakers, patient advocates and general D.C. prognosticators.
The sentiment across the biotech world is quite consistent: They are 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 was not 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 e-mailed 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 drug makers. 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 Venture Capital (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.”
First up, an interim Commissioner. According to analysts and media reports, one clear option would be Gottlieb’s principal deputy, Amy Abernethy, who was hired last December. And then, of course, the nomination of a replacement, hearings and a Senate vote.
Though no official word has come about candidates to replace Gottlieb, the Wall Street Journal put forth a couple of ideas: Norman Sharpless, Director of the National Cancer Institute and a scientist backed by Dr. Gottlieb, and Brett Giroir, Assistant Secretary at the Department of Health and Human Services (DHHS), the parent department of the FDA. Giroir is believed to be HHS Secretary Alex Azar’s favorite candidate, the WSJ reports; he has been Azar’s Senior Adviser on fighting the opioid epidemic.
Cowen & Co. analyst Eric Assaraf concurred on Sharpless and Giroir as possibilities, and noted that they share one key advantage. “Both Sharpless and Giroir have been vetted and confirmed by the Senate in the past two years so both would likely have a relatively easy route to confirmation,” Assaraf figures, though he added that confirming a new FDA chief is “rarely easy” because of its broad brief. “It’s not uncommon for Senators to have strong feelings about topics important to their states,” he said in a Wednesday investor note.
Loncar’s not as concerned about finding a decent replacement as he is about the uncertainty that will reign until then — which could be awhile, he noted. He figures finding an experienced leader with medical background and a good relationship with the industry might not be that tough. Gottlieb’s departure does not necessarily have to be a negative, he noted on Twitter. “But the thing I do worry about with the environment in Washington these days is that it will take forever for the next person to get approved,” he says.
Bernard Munos, a Milken Institute fellow and chief “innovation apostle” at InnoThink, said that is his chief concern, too. “A vacancy at the top creates uncertainty. The organization can get restless, and good people may be tempted to leave,” Munos said via e-mail.
Indeed, Gottlieb’s departure is a double-edged sword for the drug business, In the Pipeine blogger and pharma chemist Derek Lowe wrote Wednesday. Investors are bailing not just because they are losing Gottlieb; however, because they are afraid of “what might come after,” Lowe figures.
Consider the radical views of other candidates reportedly considered by President Trump before he selected Gottlieb. “Names were floated earlier of people with rather … vigorous … views on the role of the FDA in drug research, views mostly leaning towards images of a bunch of old tractor tires dumped across a busy road,” Lowe wrote. Drug makers might complain about red tape, but that does not mean they want oversight to shift into low gear. A high bar for drug approval keeps out the marginal players, Lowe pointed out. “The worry is that if someone tries to do the world a favor by getting the big ol’ slow FDA out of the way, that the result will not be a flood of grateful innovation, but rather a flood of lower-quality drug submissions,” he said.
L.E.K.’s Tzeng has his own worries, namely about the pragmatic programs Gottlieb set in motion. Now, he fears “some of these good initiatives will be stalled or reversed.”
One piece of reassurance, though: The FDA does have a deep bench, including some experts with decades of FDA work under their belts, he said. The Agency “is not short of talent and it will build up on Gottlieb’s legacy,” Munos said. “When one gets a good leader like him, the hope is that he will be around long enough to bring forward a new generation of equally capable leaders. But Gottlieb’s predecessors have been grooming talent for years, and the Agency is on solid footing.”
Detractors, then and now
Gottlieb faced criticism when he was nominated by President Donald Trump in early 2017, mainly from outside of the biopharma realm. While supporters praised his previous experience both at the Agency and with the industry, critics took issue with those very same connections.
Public Citizen at that time criticized Gottlieb for his “dangerous deregulatory approaches” and “unprecedented web of Big Pharma ties.” During his nomination confirmation hearing, Sen. Patty Murray of Washington, the ranking Democrat on the Senate Health Committee, also questioned the fact that Gottlieb had “unprecedented financial entanglements with the industries he would regulate.”
In a statement on Tuesday, Public Citizen again blasted Gottlieb. “Not surprisingly, his tenure as commissioner was marked by regulatory decision making regarding medications and medical devices that tilted further in favor of industry’s financial interests rather than the interests of public health,” the organization said, using the recent approval of AcelRx’s controversial under-the-tongue opioid Dsuvia as an example. However, he has won over at least one original naysayer. “One of the few ‘no’ votes on Trump nominees that I regret,” Sen. Chris Murphy, D-Conn., tweeted Wednesday, adding that “Gottlieb’s departure is a big loss.”
Gottlieb’s performance has won accolades from the political world. Apart from Trump’s “an absolutely terrific job” comment on Twitter, CMS Administrator Seema Verma, in a Tuesday statement, said she was “honored and privileged to […] see all that he has accomplished for the American people to spur medical innovation, increase access to generic drugs, and advance many other public health priorities.”
REFERENCE: Fierce Pharma; 06 MAR 2019; Angus Liu and Tracy Staton