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CQ Roll Call – FDA Chief's Fans Hope He Gets Passed Over for Promotion

CQ Roll Call – FDA Chief's Fans Hope He Gets Passed Over for Promotion

Food and Drug Administration Commissioner Scott Gottlieb is considered to be a leading contender to succeed Tom Price as Health and Human Services secretary. While many, including Republicans in Congress, think he is qualified for the promotion, many of his fans and allies would lament his departure from FDA.


In the five months since he was confirmed to lead FDA, Gottlieb has steered clear of controversy or drama, made overtures to Democrats who opposed him and tried to strike a balance between consumer concerns and industry demands. While those things help make a case for him as HHS secretary, there is also a fear that Gottlieb’s departure from FDA would have negative implications.


Rep. Phil Roe, R-Tenn., leads the House GOP Doctors Caucus and is a close friend of former secretary Price, another physician who was part of the caucus when he served in Congress. The caucus met with Gottlieb in July to discuss a variety of issues, including drug prices, opioid addiction and medical marijuana. Despite disappointment over Price’s shortened tenure, Roe said Gottlieb would be a worthy successor.


“He’s certainly eminently qualified,” Roe said. But, he added, “I like him where he is.”


That’s a sentiment shared by others in the days since Gottlieb, 45, emerged as one of the front-runners to succeed Price. During the George W. Bush administration, Gottlieb was an official at both FDA and the Centers for Medicare and Medicaid Services. During the Obama years, Gottlieb was a fellow at the conservative American Enterprise Institute and an advisor or board member for numerous drug companies and biotech investment firms. He is a physician by training, and was successfully treated for Hodgkin’s lymphoma, a blood cancer, in his thirties.


“He’s highly capable. Certainly his years at CMS and FDA, and his personal story, the fact he’s a physician, makes him highly qualified,” said Ellen Sigal, chairperson and founder of Friends of Cancer Research, a patient advocacy group sponsored in part by the pharmaceutical industry. “However, I think he’s doing a great job at FDA and I would be concerned because he really knows the agency well, he has a full agenda, and it would be somewhat disruptive in the short term.”


Gottlieb weighed in himself on Tuesday, addressing the speculation in an interview with Reuters. “I feel like I want to continue to follow through on the policies we’ve put out and it’s where I think I can be most effective,” Reuters quoted him as saying.


Underlying the praise for Gottlieb is a concern that whoever takes over at FDA next would be far less qualified, even dangerous. Before Gottlieb was tapped for the job, the administration was considering Jim O’Neill, a Silicon Valley investor and former HHS official who believes FDA should approve drugs that are safe but not necessarily effective.

Service So Far

Gottlieb, despite worries about his ties to the drug industry, has not dramatically shaken things up at the agency. Most of the long-time FDA officials overseeing the agency’s oversight of drugs, medical devices, food and tobacco were left in place. And Gottlieb has relationships with long-time staff and a knowledge of the agency’s work that few possess.


“They’re not going to find somebody who can do the job nearly as well as he can do it,” said Joe Antos, a scholar at the AEI who specializes in health care and worked with Gottlieb. Antos argued that the secretary of HHS, with its much broader portfolio, tends to focus on promoting a high-level policy agenda, which would be a waste of Gottlieb’s technical know-how. “For the kind of job that the HHS secretary usually is, there are lots of plausible candidates. FDA, there are very few plausible candidates,” he said.


To be sure, Gottlieb has gotten his share of criticism. An FDA announcement that it would consider requiring a lower amount of nicotine in cigarettes was praised by anti-smoking advocates. But a simultaneous decision to delay regulations of e-cigarettes drew criticism from the same groups.


Michael Carome, the director of Public Citizen’s health research group, has been a persistent critic of Gottlieb and thinks he’s led the FDA in a more industry-friendly direction. He points out how the agency rejected the application for a rheumatoid arthritis drug from drug company giant Eli Lilly & Co. in April, only to backtrack and allow the company to submit its application again without more testing. In June, the FDA approved a new treatment to reduce the risk of blood clots, despite the drug failing to show that it was much more effective than generic blood-thinners already on the market.


Those were the kinds of fears articulated by many Democrats in Congress, most of whom opposed his confirmation. However, Gottlieb has deliberately engaged with his critics in Congress and has gradually won praise, even from some who voted against him.


“Scott and I don’t see eye to eye on a lot, but I think I’ve been pleasantly surprised by some of the things he’s done and his willingness to be in communication with both his supporters and opponents,” said Sen. Christopher S. Murphy, D-Conn.


But even if he can convince Democrats that he is an able FDA commissioner, convincing them he is fit to lead HHS and its $1 trillion budget might be tougher. Any confirmation hearing is sure to give rise to a debate over the 2010 health care law (PL 111-148, PL 111-152), which Gottlieb criticized extensively as a private citizen.