Trump’s FDA pick faces questions over drug-industry ties

(This story originally appeared on The Hill Extra) 

 

President Trump’s nominee to be FDA commissioner is drawing praise from some Democrats and Republicans, though his drug industry ties and policy positions will likely raise questions during the confirmation process.

Several industry and patient groups, like the medical device trade group and Friends of Cancer Research, voiced their approval of the pick, former FDA deputy commissioner Scott Gottlieb. Some former commissioners who served under both Republican and Democratic administrations, lawmakers and other federal officials also heaped on the praise.

“I am breathing a sigh of relief,” Robert Califf, who was President Obama’s last FDA chief, said in an email, ahead of the announcement Friday.

Another candidate on Trump’s short list, Jim O’Neill, was seen as a more radical choice over his views on curtailing the role of the agency in gauging drug effectiveness.

{mosads}“Scott Gottlieb is a wise choice by the President!,” said Andrew von Eschenbach, who served as commissioner under former President George W. Bush from September 2005 until Obama took office.

“A very good choice,” Obama’s former Medicare and Medicaid chief Andy Slavitt said on Twitter, offering his congratulations. 

Gottlieb, a physician, was deputy commissioner at the FDA from 2005 to 2007 under Bush, and worked at the agency for several years before that. As a policy wonk at the American Enterprise Institute, he’s been an active voice in drug policy since then, including frequent contributions to the Wall Street Journal’s conservative editorial page.

From that perch, he’s criticized the FDA under Obama for stalling the approval of generics and critiqued presidential candidate Hillary Clinton’s proposed remedy for high drug prices. In a blog for Forbes, he waded into the debate over EpiPen, detailing how the FDA’s approval process for generic drugs has inhibited generic competition.

Gottlieb is equipped to face the scientific and policy decisions needed at the FDA, particularly to implement parts of last year’s 21st Century Cures law, said Califf and von Eschenbach.

“He is highly qualified with previous FDA experience and time in venture capital and clinical practice,” Califf said. “He knows how the FDA works.”

 

Taking the reins. 

If confirmed, Gottlieb would be in charge of the FDA at a time when medical products are more complex, with enormous pressure for access to lower cost drugs and to deliver more “value.”

That requires a modernization of the agency and its regulatory practices, said von Eschenbach.

“Scott Gottlieb is the one choice for commissioner who knows what FDA must do, and, more importantly, knows how to execute on that strategy,” he said.

Reauthorizing drug and device user fee agreements this year, moving ahead with food safety policies, and employing science-based tobacco regulations are essential priorities for the agency, Califf said.

The FDA must also keep its standard for balancing the risks and benefits of medical products while considering approaches to speed up preclinical and clinical development; improving biomarkers, for example, or using “real-world” patient data, he said. 

“The key will be finding the middle ground between those who rightly want to improve the process of medical product development and those who want maximal protection of Americans,” Califf said.  

“I believe the Center directors at FDA know where this middle ground can be found, and Scott is fully capable of working with them to find it and explain it to politicians, the public (patients) and the scientific and commercial communities,” he said. 

 

Industry relationships draw scrutiny.

The Senate Health, Education, Labor and Pension Committee is expected to vet Gottlieb’s nomination.

Committee Chairman Lamar Alexander (R-Tenn.) voiced his support for the nominee’s “impressive qualifications.”

But Gottlieb also faced criticism from groups that are concerned his ties to the drug industry could hurt the agency’s commitment to safety and efficacy.

He has longtime ties to the drug and medical industry after leaving the FDA in 2007. 

He is currently a member of the product investment board for drug giant GlaxoSmithKline, and a member of the board of directors for MedAvante, Gradalis, and Glytec, which does work in medical technology. Gottlieb is a member of the federal Health IT Policy Committee.

Public Citizen blasted Gottlieb for taking what they said was hundreds of thousands of dollars from multiple drug and device companies between 2013 and 2015, mostly for consulting and speaking fees.

“Gottlieb is entangled in an unprecedented web of Big Pharma ties,” said Michael Carome, director of Public Citizen’s health research group and a physician, in a statement.

“He has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry, and the U.S. Senate must reject him.” 

Gottlieb, who was a member of Trump’s transition team, could not be reached for comment.

 

Business ties.

Until last year, Gottlieb was a member of Tolero Pharmaceuticals board of directors and an independent adviser for Vertex Pharmaceuticals, according to his LinkedIn page.

Prior to that, Gottlieb was on the board of Aptiv Solutions, a clinical research organization, Bravo Health Insurance and Molecular Insight Pharmaceuticals.

Public Citizen contends that Gottlieb’s relationship with industry started before he got to the FDA in 2003. When he became deputy commissioner in 2005, he had to be recused from many key meetings and decisions due to his close relationship with industry, Carome said in the statement. 

“If the Senate does not reject Gottlieb, he will have to be recused from key decisions time and time again, otherwise there is no way to be sure he will put the public’s health over industry profits,” he said.

Califf also drew opposition prior to his confirmation into the Obama administration.

Despite widespread support from the chamber, a handful of senators in both parties opposed him over concerns about his ties to the pharmaceutical industry and the FDA’s strategy to combat an opioid epidemic.

Former FDA Commissioner Mark McClellan said despite his industry ties, Gottlieb is familiar with the agency, its staff and the importance of the agency’s work to public health.

Gottlieb was McClellan’s senior adviser in 2003, under the George W. Bush administration. 

 

Deregulation decisions.

Aside from Gottlieb’s industry ties, Public Citizen also raised concerns about positions Gottlieb has taken on deregulating the drug review process.

Gottlieb has signaled that he might be willing to accept a greater degree of uncertainty about safety and effectiveness at the time of a new drug’s approval, and favored looser restrictions on off-label promotion. 

“Gottlieb’s appointment would accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry than those of patients,” Carome said.

McClellan said Gottlieb knows statutory standards and science well, and his comments recognize that there are new innovations in drug development on the horizon, such as incorporating real-world evidence from patient use.

“It’s not so much about changing the standards as it about applying the best and latest medical evidence to meet the standards,” McClellan said.

 

This story originally appeared on The Hill Extra. See more exclusive content on policy and regulatory news on our subscription-only service here.