FDA chief Scott Gottlieb resigns

Scott Gottlieb, the leader of the Food & Drug Administration (FDA), is resigning his position effective next month, the Trump administration announced Tuesday.

In a note to FDA staff, Gottlieb said he was leaving to spend more time with his family.

"There's nothing that could pull me away from this role other than the challenge of being apart from my family for these past two years and missing my wife and two young children," he wrote.  

His replacement has not been announced.

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Gottlieb, a physician and cancer survivor, has been one of President TrumpDonald John TrumpBooker hits Biden's defense of remarks about segregationist senators: 'He's better than this' Booker hits Biden's defense of remarks about segregationist senators: 'He's better than this' Trump says Democrats are handing out subpoenas 'like they're cookies' MORE’s most popular appointments and appeared to be widely liked within Congress by both Democrats and Republicans.

He led the agency’s response to the opioid epidemic, and recently has been cracking down on youth vaping.

Gottlieb has also made it an agency priority to speed up approvals for generic drugs.

During his confirmation process, congressional Democrats and outside groups sounded the alarm about Gottlieb’s industry connections, warning they pose major conflicts of interest. He had investments in 20 different health-care companies that made products regulated by the agency.

Gottlieb is the only FDA commissioner who worked in the pharmaceutical industry prior to being nominated; the others have mainly come from public health or academia.

But he won over skeptics with his focus on bringing down high drug prices and reducing youth smoking rates.

His resignation was unexpected, as he recently hired senior staff.

“I want to be very clear – I’m not leaving,” he tweeted two months ago. “We’ve got a lot important policy we’ll advance this year."

In a statement Tuesday, Health and Human Services Secretary Alex Azar praised Gottlieb’s contributions to the agency.

“He has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation,” Azar said. “Scott’s leadership inspired historic results from the FDA team ... The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.

“I will personally miss working with Scott on the important goals we share, and I know that is true for so many other members of the HHS family,” Azar added.

In his resignation letter, Gottlieb listed a host of agency accomplishments under his tenure, including a record number of generic drug approvals. He lavished praise on agency staff for being able to avert drug and device shortages in the aftermath of Hurricane Maria in Puerto Rico.

This was Gottlieb’s second stint at FDA. He served as a deputy FDA commissioner under former President George W. Bush before leaving the agency in 2007.

After he left the agency, Gottlieb served on the boards of pharmaceutical companies, worked as a venture capitalist and was a resident fellow at the American Enterprise Institute, a conservative think tank.

Gottlieb’s resignation occurs as his signature plan to crack down on the “epidemic” of youth vaping is poised to be released.

The FDA rule that would sharply limit the sales of flavored e-cigarettes, which he says are attractive to kids, is under review at the White House.

Gottlieb has tried to balance restricting the sales of e-cigarettes to youth, while also making sure they are available as a tool to help adults quit smoking traditional cigarettes. He has frequently threatened companies that he would pull their products off the market if they didn’t stop marketing to teenagers.

The rule has not been made public yet, but Gottlieb has previously proposed limiting the sales of most flavored e-cigarettes to age-restricted, in-person locations, effectively ending sales at gas stations and convenience stores.

He also recently requested meetings with the leaders of e-cigarette manufacturers and large retailers about what they’re doing to keep the devices away from kids.

The initiative drew praise from some anti-tobacco activists, but was criticized by conservatives and some Republican members of Congress who said he was going too far.

“The FDA is a stand out agency, across the administration, that’s moving in the completely wrong direction,” said Paul Blair of Americans for Tax Reform, which led a coalition of conservative groups seeking to block the changes.

Blair, in an interview before Gottlieb’s resignation, said the commissioner’s approach to regulation is inconsistent with the president’s agenda.

"Without your intervention, Commissioner Gottlieb may not only destroy tens of thousands of jobs at small stores and manufacturers, but he will prevent some of the more than 35 million American adults who still smoke tobacco cigarettes from ever successfully quitting," ATR and 18 other groups wrote in a letter to Trump last month.

Tobacco stocks briefly spiked on the news Gottlieb was planning to resign; shares of Altria, which recently invested $13 billion in e-cigarette maker Juul, jumped almost $2 a share before leveling off.  

President Trump on Tuesday tweeted that Gottlieb “has done an absolutely terrific job as Commissioner of the FDA.”

“Scott has helped us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. He and his talents will be greatly missed!" Trump said.

Gottlieb waded into the drug pricing fray shortly after he took charge of the agency. He wrote in a public blog posting that high drug prices are “a public health concern that FDA should address.” In a speech, he said he wanted to “end the shenanigans” that interfere with competition.  

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The FDA has historically stayed out of the drug pricing debate, but Gottlieb insisted the pricing issue fits with the agency's mission. In an interview with The Hill last year, he said unleashing free market forces is the key to lowering drug prices.

Members of Congress who worked with Gottlieb called him an effective leader and public servant.

“In all my years of public service, I’ve never worked with a more talented, forthright, and effective agency leader than Dr. Scott Gottlieb," said Rep. Greg WaldenGregory (Greg) Paul WaldenKey senators release bipartisan package to lower health care costs Key senators release bipartisan package to lower health care costs Hillicon Valley: Democratic state AGs sue to block T-Mobile-Sprint merger | House kicks off tech antitrust probe | Maine law shakes up privacy debate | Senators ask McConnell to bring net neutrality to a vote MORE (R-Ore.), the top Republican on the House Energy & Commerce Committee.

"He worked effectively with Congress to find solutions and to improve the quality of life for all of us."

Updated at 5:26 p.m.