The explosion of tobacco use among kids, biosimilars, OTC reform and ongoing efforts to address high prescription drug prices are among areas of unfinished business as Food and Drug Commissioner Scott Gottlieb prepares to leave his post.
During a conversation at The Brookings Institution on Tuesday reflecting on his approximately two-year stint as commissioner, Gottlieb said his final day will likely be April 5 to allow him time to testify on his agency's budget before a congressional committee on April 3. "There's no one else who wanted to do it," Gottlieb joked.
He said he has not yet determined where he will go next but said he is planning a trip with his family to Disney World.
As for the timing of his departure, Bloomberg reporter Anna Edney asked about a January tweet from the commissioner in which he posted that he did not plan to leave the agency after he said a reporter had begun making calls to his friends asking about the commissioner's plans. “I want to be very clear—I'm not leaving,” Gottlieb said at the time. “We’ve got a lot [of] important policy we’ll advance this year."
Almost exactly two months later, he announced his resignation.
Gottlieb said the article he was referencing in January was going to say he was going to announce his resignation within a week.
"Look, this has been a difficult decision and I've been going through a week of speculation about what the real reason is I've left because you can't possibly have left for personal reasons because you miss your family and you're not seeing them," Gottlieb said. "There really wasn't more intrigue to the story."
He said he'd planned to stay through the end of the summer, but his weekly commute to Connecticut to see his family on the weekends mixed with the demands of the job were becoming too much. He said in retrospect, he would have moved his family to D.C. rather than trying to commute.
"It's very difficult to walk away from this job. It's the best job I'll ever have," Gottlieb said. "But I feel really good about the inflection point the FDA is at right now. If I didn't, I wouldn't have done it."
Here's what else he had to say during the hourlong discussion:
On the threat of youth smoking due to e-cigarettes:
"If you see e-cigarette use go up 40% next year, which isn't out of the question, you'll see cigarette use among kids go up because at that level of e-cigarette use you're going to start to see cigarette use start to creep back up. … You'll be at levels of tobacco use among children in this country of 40% to 45%. That's simply intolerable. I went back and looked at data going back to 1950, and we haven't seen that level of use of tobacco among kids. The e-cigarettes are tobacco products, and nicotine is addictive, and it does have direct effects on the developing brain of a child. … All the dramatic gains we've made in reducing smoking rates in this country, particularly among young people, will be reversed as a result of these products."
On the long-lasting impact of the government shutdown:
"In my view, this was the biggest operational challenge we've faced in modern times in my observance of the agency over the last two to three decades. … I think the agency has recovered from the shutdown very admirably, very effectively. We haven't seen immediate impacts on hiring. We haven't seen an immediate increase in departures. I think the long-term impacts are going to be judged by what impact it does to the perception of government service overall to people who might have stayed on for another couple of years or who might not have retired. … The place where we'll see some slippage is the overall inspection numbers for the year. They'll be down an amount that's not fully commensurate with the time we were shut down because we were able to get a lot of the inspections back up. But they'll be down some portion.
On CBD in the food supply:
The issue for us is, the farm bill was passed and hemp is now legalized. Farmers who grow hemp want to be able to extract CBD as a commodity and sell it. Packaged food producers want to be able to look at putting CBD into the food supply, but because it didn't previously exist in the food supply, and it exists as a drug, … it can't just be put into the food supply. We've never done this before. It would be a highly novel rule-making process. … We're putting together a work group right now. We're going to announce it within a week, and we're going to have a public meeting around this issue. ... What the work group is going to look to do is look to what some potential legislative pathways might be.
On unfinished business that he wants to see get addressed:
The things I wanted to see through that I won't be around to see through are some of the legislative initiatives that we worked on. So OTC reform, … the bill that would have fashioned a modern framework for the regulation of diagnostics. Those were on a longer time horizon but certainly were not going to happen on my time frame. I'm hopeful they'll happen within the next 12 months and won't sit out there. … OTC in particular I think is ready and would be a very productive modernization of the pathway to getting OTC pharmaceuticals to the market and open up a lot of innovation for products that can be sold over the counter and open up new categories—not just new formulations of products—that can be more convenient or lower cost for consumers.
On prescription drug pricing and the impact of biosimilars:
I would look first and foremost to some of the commercial biosimilars and the fact that the incumbent biologics have large royalties associated with them and the manufacturers are smart. They amp up the royalties on the eve of the biosimilar entry. If you're a health plan and you adopt a biosimilar onto your formulary, you lose all the rebates. To offset the lost rebates, you have to be able to move enough market share to the biosimilar to take advantage of the discount the biosimilar is entering the market at to offset that lost revenue from the rebates. That is hard to do in this market because plans seem to have a hard time converting physicians and patients over to the biosimilars. It's not just a question of interchangeability and automatic substitutability. It's a question of some physicians' resistance right now, particularly to some biosimilars that are being used in curative therapy. I think as the market develops and doctors gain more acceptance and comfort with biosimilars, and more biosimilars are developed against chronic therapy biologics where I think there will be more clinical comfort in converting patients over to them, this market will evolve and be very robust.
On how health plans are embracing this change:
If you look back at Hatch-Waxman, the embrace of generics on the market was slow as well. The biggest impediment is the commercial impediment. I think if they look beyond the next quarter and look at the long run and recognize that if they put a biosimilar in their formulary, they might lose money for a quarter when they lose their rebates. But if they convert their population over a two-year period, they are going to create a lot of competition that is ultimately going to lower their drug spend. I think they need to take a long view here. The captive health plans seem to do that if you look at Intermountain Health and Kaiser, they seem to do a good job with that because they have more control over utilization.