Food and Drug Administration Commissioner Dr. Scott Gottlieb’s resignation prompted widespread appreciation for his work but also apprehension as to whether initiatives he’s championed will carry the same weight after his tenure.
Gottlieb unexpectedly issued his resignation letter March 5, stating that he will leave in a month. He told the Washington Post that he wants to spend more time with his family. Sources intimated that Principal Deputy Commissioner Dr. Amy Abernethy would take over his post on an interim basis, although the FDA said it didn’t have any information to share at press time.
Gottlieb displayed an unprecedented level of activity and transparency during his tenure, which will be hard to replicate, experts said.
“I am very concerned about the possibility of losing the remarkable momentum that Scott established,” Dr. Eric Topol, executive vice president of Scripps Research, wrote in an email to Modern Healthcare.
Besides being one of the most progressive commissioners in his support of innovation in drugs, devices and diagnostics, Gottlieb also took on stem cell clinics, supplements and stood up for science in his defense of vaccinations, among many other bold initiatives, Topol said. “Most commissioners in the past, and certainly those who were ‘interim,’ were too unwilling to take on these controversial, and vital, issues,” he wrote.
One of Gottlieb’s lesser-known talents was getting senior agency officials to buy into his efforts and regulatory philosophy, said Peter Pitts, president of the Center for Medicine in the Public Interest. Gottlieb, who worked alongside Pitts at the FDA as senior adviser under former commissioner Dr. Mark McClellan, hit the ground running and with purpose, Pitts added.
“The way a commissioner creates a legacy is to imbue senior staff with your vision,” he said. “Those programs will continue because there is now ownership by the career staff.”
In his resignation letter, Gottlieb outlined a range of endeavors introduced during his two years as commissioner. He spotlighted everything from his efforts to confront teen vaping and decrease the rate of opioid addiction to improving access to generic drugs and modernizing the development process for new medical technologies like gene therapy and targeted medicines.
The FDA also helped mitigate drug and device shortages after Hurricane Maria pummeled Puerto Rico and restored critical functions during the recent government shutdown, addressing each issue through the lens of transparency, Gottlieb wrote.
“This is a guy who has gotten far and away the highest job marks of any commissioner I have seen, particularly when you consider that he has gotten respect across the board, which is unusual,” said Jim Shehan, senior counsel with Lowenstein Sandler and chair of the firm’s FDA regulatory practice. “That’s quite a list for a two-year tenure.”
But many initiatives are still underway, Shehan noted, and it’s not certain that they will come to fruition.
Biosimilars, which are cheaper substitutes for some of the biggest drivers of drug spending, have only recently gained more traction. The FDA’s delayed regulatory blueprint restricting flavored e-cigarettes is being reviewed by White House officials. A proposed ban of menthol cigarettes, limitations on flavored cigars and reduction of the nicotine in cigarettes are still in the works.
“That’s what everyone is worried about, if (the next commissioner) will be able to keep this positive action going. It very much depends on who that pick is,” Shehan said, adding that Abernethy would be a good fit.
Industry stakeholders will likely adjust their strategic direction and reposition accordingly. Notably, stock prices for tobacco companies like Altria, Imperial Brands and British American Tobacco surged after Gottlieb’s announcement. Associations like the Americans for Tax Reform have been critical of Gottlieb’s stance on tobacco, claiming that a ban on menthol cigarettes will lead to an illicit underground market.
Analysts from investment bank Cowen said Gottlieb’s departure will not likely change the FDA’s direction on issues like drug pricing, tobacco and e-cigarettes. On the other hand, Gottlieb’s political instincts, personal relationships, media savvy and ability to garner bipartisan support changed the way the agency does business and allowed him to address topics that other FDA commissioners shied away from, analysts said.
Gottlieb was particularly outspoken regarding introducing more generic drugs to increase competition in the pharmaceutical sector, as well as about the “shenanigans” branded manufacturers used to thwart competitors. He used his bully pulpit to speak out early and forcefully about branded-drug companies withholding samples needed by generic-drug makers, rebate traps and other anti-competitive practices, the Association for Accessible Medicines said.
During his tenure, the agency announced new policies related to its Risk Evaluation and Mitigation Strategies program so branded-drug makers couldn’t block generic competitors, a practice lawmakers are taking aim at with the Creates Act, which is expected to pass this Congress.
The FDA expedited the review of generic-drug applications until there are three approved generics for a product. It also cleared the orphan-drug request backlog as it aims to streamline its application process and has made a significant dent in the backlog of generic-drug applications.
These endeavors contributed to the approval of a record-setting 971 generic drugs in fiscal 2018, up 3.6% from 937 in 2017, aided by the boost in staff following the renewal of the Generic Drug User Fee Act. The FDA approved a record 59 new drugs and biologics in 2018, including 19 first-in-class therapies. But nearly 550 off-patent brand drugs still lack competition, according to a list the agency published last year meant to increase transparency.
S&P Global Ratings’ analysts warned that Gottlieb’s resignation could slow approval rates and times.
“I hope his successor continues with these initiatives along with facilitating eliminating barriers to biosimilars,” said Scott Knoer, chief pharmacy officer of Cleveland Clinic.
Gottlieb did a great job improving the generic-drug review and approval process, but more needs to be done to address branded drugs that have no competition, said David Rosen, a partner with Foley & Lardner and former FDA official.
“I still think the barrier to entry for generics is pretty high,” Rosen said, citing often insurmountable costs. “Also, the whole issue about patent certification is still subject to a fair amount of debate and clarification.”
The FDA forced Endo Pharmaceuticals to withdraw its opiate painkiller, cracked down on sites that marketed illegal and counterfeit pharmaceuticals and placed new restrictions on the use of opioids in children’s cold and cough medicines. But it also recently approved a potent pain pill, Dsuvia, which garnered criticism.
More controls need to be put in place in respect to the prescribing and dispensing of opioids to ensure they are not diverted, Rosen said.
The FDA also created a Drug Shortage Task Force last year, which seemingly will remain in place, said Erin Fox, senior director of drug information and support services at University of Utah Health.
“Dr. Gottlieb made so many positive changes, I hope an interim would continue his agenda, but it is really concerning to think that progress won’t continue,” she said.
Prior to his role as commissioner, Gottlieb was a resident fellow at the American Enterprise Institute and a clinical assistant professor and practicing physician at the New York University School of Medicine. He also had close ties to pharmaceutical and device companies, advising GlaxoSmithKline and serving on the boards of other drug and device makers. This drew concern from industry experts that was largely dispelled during his time as commissioner.
“What I admired most about his leadership of a federal agency was how he privately respected and publicly elevated the agency’s civil servants and division leaders,” Dr. Farzad Mostashari, a former national coordinator for health information technology at HHS and CEO and co-founder of Aledade, tweeted after Gottlieb announced his resignation. “He truly understood that the work of the agency is done by its staff, and their morale and well-being matters.”
