FDA Commissioner’s Decision To Resign At End Of Month Catches Washington, Industry By Surprise

The New York Times: F.D.A. Commissioner Scott Gottlieb, Who Fought Teenage Vaping, Resigns
Scott Gottlieb, the commissioner of the Food and Drug Administration, known for his aggressive efforts to regulate the tobacco and e-cigarette industries, said on Tuesday that he would resign at the end of the month. The reason he gave was family and his weariness with commuting to see his wife and three children, who have remained in their Westport, Conn. home since he took office. But his announcement caught many in Washington and the industries he regulates by surprise and raised questions about whether his push to reduce teenage vaping and lower nicotine levels and ban menthol in cigarettes will continue in an administration that generally has a hands-off approach to business. (Kaplan and Hoffman, 3/5)

Stat: FDA Commissioner Scott Gottlieb To Resign 
“Over the past 23 months, I’ve been privileged to work with an outstanding team at the Food and Drug Administration, and to collaborate with the professional staff on implementation of many meaningful incentives that have advanced the public health,” Gottlieb wrote. “I’m fortunate for the opportunity that the President of the United States afforded me to lead this outstanding team, at this time, in this period of wonderful scientific advances.” (Facher, Florko and Swetlitz, 3/5)

Reuters: U.S. FDA Chief Tough On E-Cigs Steps Down In Surprise Resignation
Gottlieb was well regarded by public health advocates and won bipartisan support for his efforts to curb use of flavored e-cigarettes by youths, speed approval times for cheap generic medicines to increase competition and bring down drug prices, and boost the use of cheaper versions of expensive biotech medicines called biosimilars. Unlike his predecessors, who said drug pricing was not the purview of the FDA, Gottlieb waded into the intensifying debate about the high cost of medicines for U.S. consumers and had the agency actively looking into possible solutions. (Abutaleb, 3/6)

The Washington Post: FDA Commissioner Gottlieb, Who Raised Alarms About Teen Vaping, Resigns
“It was a very hard decision,” Gottlieb said in an interview. “This is the best job I will ever have. I’m leaving because I need to spend time with my family. I get home late Friday, work on weekends and come back to Washington on Sunday. I did the job 100 percent." The resignation was not sought by the White House. A senior White House official said Gottlieb had spoken to President Trump, and that the president liked the FDA chief and did not want him to leave. (McGinley, Bernstein and Dawsey, 3/5)

The Associated Press: FDA Chief Scott Gottlieb Steps Down After Nearly 2 Years
President Donald Trump tapped Gottlieb in 2017 to “cut red tape” at the FDA. But Gottlieb bucked expectations by pushing the agency to expand its authorities in several key ways, including an unprecedented effort to make cigarettes less addictive by requiring lower nicotine levels. The 46-year-old physician and former conservative pundit advanced his agenda while managing to maintain the support of the president, Republicans and key Democrats in Congress. (Perrone, 3/5)

The Wall Street Journal: FDA Chief Scott Gottlieb To Leave Agency
A 46-year-old physician, Dr. Gottlieb joins a long list of other senior Trump administration officials who have left their roles. Dr. Gottlieb, who has been commuting to Washington from Connecticut during the workweek, has told those close to him he is resigning to reduce the strain on his wife and three young children. His exit will take effect sometime over the next month, after which he is likely to seek a post in the private sector, according to people familiar with his plans. “All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA,” Mr. Azar said. “He has been an exemplary public-health leader, aggressive advocate for American patients and passionate promoter of innovation.” (Burton and Maloney, 3/5)

Politico: ‘Something Very Rare’: FDA’s Gottlieb Aggressively Tackled Difficult Issues
FDA leaders have typically focused much of their attention on a handful of medical topics, but Gottlieb has been active and aggressive on many issues as commissioner without hewing to a strictly conservative or liberal ideology. It’s an approach that’s won him praise from many in the health sector, while garnering criticism from several of the targeted businesses like tobacco companies and the fast-growing e-cigarette industries. “He was able to do something very rare: He never got embroiled in a scandal, never got labeled with a toxic administration brush and had a great relationship with the President all at the same time,” said one former White House official. (Owermohle, Karlin-Smith and Bottemiller Evich, 3/5)

The Hill: FDA Chief Scott Gottlieb Resigns 
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 Walden (R-Ore.), the top Republican on the House Energy & Commerce Committee. (Hellmann and Weixel, 3/5)

CQ: FDA Commissioner Departing Next Month
Gottlieb was particularly deft at maintaining relationships on Capitol Hill after a mostly partisan confirmation vote in 2017. His inner office included Republican staff alumni of the Energy and Commerce Committee and the Senate Health, Education, Labor and Pensions committees. He recently hired Doug Andres, who last worked for former Speaker Paul D. Ryan of Wisconsin. The commissioner made efforts to win over Democrats, often by focusing on granting some of their parochial requests. He appeased members of New England delegations by accommodating exceptions for added sugar labeling in honey and maple syrup, and won over dairy country lawmakers by opening up a process to consider whether plant-based milks can really be called "milk.” (Clason and Siddons, 3/5)

NPR: FDA Commissioner Scott Gottlieb Announces He Will Resign
Gottlieb was not without his critics. Public Citizen, a consumer advocacy organization, disapproved of his recent decision to approve Dsuvia, a powerful opioid painkiller. Despite Warnings, FDA Approves Potent New Opioid Painkiller"[H]is 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," Dr. Michael Carome, Director of Public Citizen's Health Research Group, said in a statement. (Wamsley and Wroth, 3/5)

Stat: On Twitter, Praise For Scott Gottlieb Sprinkled With Dissenting Views 
Scott Gottlieb is stepping down as leader of the FDA — and many in health and medicine quickly turned to Twitter to express their displeasure. Gottlieb, who has served as the commissioner of the Food and Drug Administration since May 2017, announced on Tuesday that he plans to leave his post in one month. During his tenure, the FDA broke annual records for generic drug approvals, cracked down on unproven stem cell treatments, and took new steps to curb youth e-cigarette use. (Thielking, 3/5)

Stat: Scott Gottlieb’s Sudden Resignation Will Give Biotech A Panic Attack 
Scott Gottlieb, the highly effective and well-liked commissioner of the Food and Drug Administration, announced Tuesday that he would quit, leaving himself only a month to wrap up his plans like spurring the development of new drugs and regulating electronic cigarettes. That news is likely to leave biotech and pharma executives, who largely adored Gottlieb, nervous at best and frightened at worst. Likewise, health care investors. (Herper and Feuerstein, 3/5)