Gottlieb Confident in FDA's Direction as His Departure Nears

The decision to leave the agency did not come easily, but the commissioner said he feels good about where things are headed and who's in charge.

Scott Gottlieb, MD, the outgoing commissioner of the Food and Drug Administration, expressed confidence Tuesday in where the agency is headed as he prepares to leave his post in the coming weeks, having served nearly two years with the Trump administration.

During a moderated discussion at the Brookings Institution in Washington, D.C., Gottlieb affirmed earlier reports that he decided to resign, as announced earlier this month, to spend more time with his family. Gottlieb has been commuting to D.C. from their home in Westport, Connecticut, leaving very little time with his children.

Despite the clarity of his reasoning, the decision to leave the FDA did not come easily, Gottlieb said.

"This is the best job I'll ever have," he added.

Gottlieb said the agency's team is competent and prepared to keep rolling out a robust policy agenda in his absence.

"I feel very good about the inflection point that FDA is at right now, stepping away from that," he said, adding that he wouldn't be leaving now if he weren't so sure the FDA would continue to succeed.

Gottlieb said he's "a big fan" of National Cancer Institute Director Norman E. "Ned" Sharpless, MD, who will be named acting FDA commissioner and is said to be in the running to serve as Gottlieb's permanent successor, as The Wall Street Journal's Thomas M. Burton reported last week.

Gottlieb said he's planning to testify before Congress on Wednesday, April 3, about the budget proposal for fiscal year 2020, then serve his final day as FDA commissioner on Friday, April 5. (After that? He's planning a trip to Disney World with his kids.)

Government Shutdown Fallout
 

There were rumors in January that Gottlieb's resignation was imminent, amid a partial government shutdown that shuttered core functions of the FDA for 35 days, but Gottlieb said Tuesday that he would not have left FDA in such a state.

When asked about the shutdown, which stemmed from a dispute between President Donald Trump and Congress over Trump's demand for billions of dollars in funding for a southern border wall, Gottlieb said the ordeal was a major setback for the FDA's progress.

Related: Despite Early Skepticism, FDA's Scott Gottlieb Won Wide Approval

"In my view, this was the biggest operational challenge we faced in modern times in my observance of the agency over the last two or three decades," Gottlieb said. "We've faced operational challenges, but they were in a discrete area of activity. This was across the board."

Gottlieb said the FDA has recovered "admirably" from the shutdown but will likely finish 2019 about 5%-10% behind on routine drug and device inspections. And there could be longer-term negative impacts if the shutdown tarnishes the way FDA workers view their government service, he said.

Impediments to Biosimilars
 

The FDA unveiled a biosimilar "action plan" last summer that aims to promote drug affordability through competition. But there are still major hurdles, including a commercial impediment, Gottlieb said.

Health plans have a tough time getting physicians and patients to switch to biosimilars, and health plans are hesitant to move away from the big rebates name brand drug manufacturers can offer, he said, arguing that health plans would reduce their overall drug spend in the long run if they pushed toward biosimilars in the near term.

Related: Why the U.S. Remains the World's Most Expensive Market for 'Biologic' Drugs

Some predictions in the early 2000s were a bit bold in how quickly and deeply biologics would penetrate the market, Gottlieb said. Even so, he's still optimistic.

"I think as the market develops, as doctors gain more acceptance and comfort with biosimilars, as more biosimilars are developed against chronic therapy biologics—where I think there will be more clinical comfort in converting patients over to them—I think this market is going to evolve and be very robust," he said. "It's been slow to develop, but it hasn't surprised me that it's been slow to develop."