Helping foster gene therapies; overhauling medical device reviews; using nutrition to fight disease: They’re all priorities for FDA in 2018, Commissioner Scott Gottlieb said on.
“We’re going to announce in the next couple of weeks a policy road map,” Gottlieb said. “[It’s] going to lay out what our 2018 agenda’s going to be, or at least a good part of it.”
Story Continued Below
Gottlieb, who was tapped by President Donald Trump to reform an agency the president had criticized as “slow and burdensome,” has overseen a flurry of activity to speed up FDA, including approving more than 1,000 generic drugs last year, a record.
One major focus in 2018: gene therapy, just months after FDA approved its first. “We think we’re at an inflection point,” Gottlieb said, adding that FDA will likely put out disease-specific guidance on how to develop gene-therapy products, how to define the endpoints and how to create accelerated approval pathways.
Another priority is a renewed focus on nutrition. “It’s going to be a comprehensive initiative,” Gottlieb promised. “We’re going to look at how we can use tools of labeling of food ingredients as ways to help create better incentives for people to adopt better diets and for food producers to produce products that have more healthful attributes.”
Gottlieb added the agency will ramp up food safety, particularly after a recent report that found some products recalled by the FDA were being left on the shelves for months, putting consumers at risk for poisoning. “One recall that isn’t done appropriately or efficiently is one too many, so we take this very seriously,” Gottlieb said. “We’re going to look to provide more information around where you might have received a recalled product” and name the retailers, a departure from previous FDA practice.
The commissioner also touted a significant effort on “trying to facilitate access to biosimilars in the same way we did with small-molecule generic drugs.” And he promised a “comprehensive framework” on modernizing medical device safety.
On the podcast, Gottlieb talked about the agency’s growing role in regulating tobacco and its strategy to reduce smoking-related deaths. For instance, FDA is steadily advancing a proposed rule intended to make cigarettes non-addictive. The agency is also seeking to regulate flavors in tobacco products, including e-cigs, to make them less appealing to youth.
“Those are two of the bigger public health pieces,” Gottlieb said, arguing that all aspects of FDA’s tobacco cessation plan need to succeed because they’re built to reinforce each other. “This isn’t a potluck approach to policy-making — this is an all-or-nothing approach.”
The FDA commissioner also reflected on Puerto Rico’s ongoing recovery from hurricanes that devastated the island last fall and crippled its medical products sector. While the disaster exacerbated some medical shortages in the continental United States, Gottlieb mostly focused on his long-term concerns for the island. “The economic health of the island is dependent on [medical products], and so we need to do what we can to help the island maintain the vibrancy of that sector.”
The commissioner also discussed why he decided to take the job and how he prioritizes his work, given FDA’s vast responsibilities. As commissioner, “you literally have a mini-crisis every day,” Gottlieb said. “If you just focus your whole day on that … you’re not going to move the policy agenda, and so you need to position yourself and staff yourself to be able to do both simultaneously.”
Not seeing the podcast?to listen on Simplecast and to subscribe on iTunes.