Reactions to Tuesday’s resignation of FDA Commissioner Scott Gottlieb, MD, have generally been characterized by surprise as well as praise for the job he has done.
Gottlieb’s official reason for leaving was that he wanted to spend more time with his family, something he elaborated on Wednesday in a video interview with The Hill. “I was commuting from Westport, Connecticut with three young kids. I would get home late Friday night, have dinner with my wife, see my kids on Saturday, work all day Sunday, and be back on the train Sunday night. Two years of that got hard; it got hard on the family.”
“If I had to do it over again, I think I would have moved them down here from the outset, but I didn’t, and it’s too late to do that now,” he added.
“I was totally shocked; we were definitely not expecting this,” said Antonio Ciaccia, cofounder and researcher at 46Brooklyn Research, a non-profit drug pricing research firm in Columbus, Ohio. “It seemed like he was still kind of mid-stride. You’d think he’d be finishing things up, putting a bow on something, but he’s right in the middle on a lot of big things, so to see him announce he was stepping away was very surprising.”
“I was about as floored about his resignation as it gets,” said Julius Hobson Jr., JD, senior policy advisor at Polsinelli, a Washington consulting firm. “He was clearly someone doing a good job, and who everybody respected.”
Hobson also said, “You can’t find anybody anywhere who is happy about his leaving,” but that proved to be untrue.
“Scott Gottlieb was entangled in an unprecedented web of Big Pharma ties when he was nominated in 2017 to be FDA commissioner,” said Michael Carome, MD, director of Public Citizen’s Health Research Group, in a statement headlined “Good Riddance to FDA Commissioner Scott 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.”
“This includes the recent, reckless decision to approve the super-potent opioid, Dsuvia, and the withdrawal of a proposed rule that would have allowed generic drug companies to promptly update their labels with new warnings,” Carome continued. “It’s imperative, but sadly unlikely, that the next nominee for FDA commissioner be someone who is independent from industry ties and will make protection of public health the agency’s top priority.”
One of Gottlieb’s most prominent targets, the electronic cigarette industry, also wasn’t sorry to see him go. On Twitter, the American Vaping Association faulted Gottlieb for not doing more to help “small- and medium-sized businesses” stay open — presumably meaning those selling e-cigarettes, which Gottlieb blamed for hooking a new generation of youth on nicotine.
But anti-tobacco advocates also expressed frustration with Gottlieb. “We are really in that ‘Never-Never Land’ with him right now, and that couldn’t be more true with regard to tobacco,” Matt Myers, president of the Campaign for Tobacco-Free Kids in Washington, said in an interview. “He talked about reducing nicotine, eliminating menthol cigarettes, and curtailing the sale of flavored tobacco products across the board — so far all of these are just promises … It remains to be seen whether people look back on him as someone who made very strong public statements and promises and didn’t deliver … When so many of these policies are at such a crucial juncture, it is hard to imagine why he would depart now.”
The American Cancer Society Cancer Action Network, on the other hand, lauded Gottlieb for his work on reducing tobacco consumption. “As head of the FDA, Commissioner Gottlieb successfully elevated the burden of tobacco use, particularly among youth, as an urgent issue of national importance with deadly consequences,” Lisa Lacasse, the group’s president, said in a statement.
“On behalf of those impacted by cancer, we appreciate Commissioner Gottlieb’s intent to lower nicotine levels and prohibit menthol flavoring in cigarettes, along with a commitment to restrict the sale of other flavored tobacco products, including cigars and e-cigarettes. If fully implemented, those key measures would significantly improve the health of our nation and reduce cancer death. These proposals must move forward despite the commissioner’s departure.”
Ciaccia praised Gottlieb’s innovations in the position. “He’s brought a lot of fresh ideas, perspective to the office, and broke a lot of — I don’t want to call them taboos, but he did things differently from his predecessors. He had a good real-world perspective he brought in.”
Take drug pricing, for example. “What he did with bringing more generics to the marketplace — that’s a recognition there’s a drug pricing issue, and he did what he could to alleviate it,” Ciaccia said. “Even though the FDA doesn’t get into drug pricing much, he criticized the broken rebate system and how it’s inflating drug prices. He was one of the first ones to call rebates what they are, which is kickbacks. To have that come from the FDA commissioner is no doubt why the football has been moved so far down the field on this issue.”
Some of those who were initially concerned about Gottlieb’s appointment spoke positively of his tenure. “In general, he was far better than I imagined he would be as FDA commissioner,” Marsha Simon, PhD, a consultant with expertise in drug pricing, said in an email. “He used his knowledge of drug companies (from working for them) to try to rein them in.”
As for who might be Gottlieb’s replacement, no names have circulated broadly, although Politico reported that National Cancer Institute Director Norman Sharpless, MD; Amy Abernethy, MD, PhD, FDA’s principal deputy commissioner; and Health and Human Services Assistant Secretary for Health Adm. Brett Giroir, MD, had been floated as possibilities.
Contributing Writer Salynn Boyles contributed to this article.
Source: MedicalNewsToday.com
