Senate confirms Gottlieb as FDA chief; former FDA tour, industry ties signal solid choice despite Dems’ jabs

The News:

The US Senate voted 57 to 42 on Tuesday (May 9, 2017) to confirm Scott Gottlieb, MD, as Food and Drug Administration (FDA) Commissioner. Gottlieb, who was nominated by US President Donald Trump for the position in March, has pledged to divest financial interests in more than a dozen companies and temporarily recuse himself from decisions involving at least 20 firms in which he held a financial stake or served as a consultant.

The US Senate voted 57 to 42 to confirm Scott Gottlieb, MD, as @US_FDA Commissioner Click To Tweet

Gottlieb, who previously served as deputy commissioner of the agency under former President George W. Bush, has held a number of roles in the industry, including serving as a director or advisor for drugmakers including GlaxoSmithKline PLC, Bristol-Myers Squibb Co. and Vertex Pharmaceuticals Inc. During nomination hearings, Democratic lawmakers questioned whether Gottlieb’s ties to industry would affect his ability to independently lead the agency.

“He has not convinced me he can withstand political pressure from this administration, or that he will be truly committed to putting our families’ health first,” remarked Senator Patty Murray, adding “I’ve grown increasingly concerned about whether he can lead the FDA in an unbiased way, given his unprecedented industry ties.”

Gottlieb’s appointment comes after Trump promised to streamline the process by which the FDA approves drugs, which he termed “slow and burdensome.” The President has also called on drugmakers to take steps to lower drug prices.

Steve’s Take:

Finally, a Trump nominee with the right stuff to do the job his regulatory agency was meant to do. And even The New York Times in its coverage of Dr. Gottlieb’s confirmation didn’t rake him over the coals for being just another Trump puppet. Of course, as we’ve seen recently, Trump appointees (e.g., former national security adviser Michael T. Flynn) don’t necessarily last long in their new jobs before hearing, “You’re fired!”

“We are at a critical juncture in the effort to help accelerate the discovery, development, and delivery of new cures and treatments, and Scott will be an important ally in that journey,” Rep. Greg Walden (R-OR), chairman of the House Energy and Commerce Committee, and Rep. Michael C. Burgess (R-TX) said in a statement welcoming the Senate vote.

For his part, Gottlieb, 44, has simply said he considers his experience valuable for his new job, and has vowed to recuse himself for the coming year from matters involving companies that he worked with. I’m quite certain he will, or he’ll hear from the Left immediately.

But those prior associations may not ultimately sway Gottlieb’s decisions as FDA commissioner. Previous heads of the agency have also had relationships with the biopharma sector, including Oamba FDA chief Dr. Robert Califf, and it’s rare for a commissioner to get personally involved in individual company-related decisions.

Pivoting back from the purely political, nowadays obligatory, gnashing of teeth by Democrats, Dr. Gottlieb steps into a job, unlike his boss in the White House, with prior government employment experience at the FDA he now leads.

Gottlieb’s nomination also likely got a boost from the Trump administration’s early tease with two other candidates, says STAT News. Both are libertarians who advocated radical overhauls to the FDA. Compared to them, he came off as utterly moderate.

A resident fellow with the conservative American Enterprise Institute, Gottlieb has a long written record of articles, speeches, and congressional testimony that lay out his vision and explain his priorities. He has expressed concern about the safety of the nation’s blood supply; called for easing restrictions on truthful, off-label promotion of medical products; and vowed to focus on combating the opioid epidemic and ensuring food safety.

He’ll also have to tackle other major tasks, such as implementing the 21st Century Cures Act, a complex directive requiring the FDA to speed up and modernize its approval process for drugs and medical devices, among other priorities.

Will Dr. Gottlieb have to follow Trump’s orders to repeal two regulations for every new one? He’s not his puppet at this point, so no. Will he have to blindly accept deep budget cuts that could affect his ability to implement the 21st Century Cures Act? That, on the other hand, he could.

He “sounds like a progressive person who wants to get things done,” said Eli Lilly & Co. Chief Executive David Ricks in an interview. “He’s got experience in the agency already. He’s a doctor and a cancer survivor. Sounds to me like he has a balanced perspective.”

And it wasn’t a simple skin cancer in his case. Gottlieb was successfully treated for Hodgkin’s lymphoma, so he’s been a sick patient and seen US health care firsthand, if only from the privileged perspective. He’s been mum on the GOP’s health-reform plan.

Some researchers question how much further the FDA can go in speeding up drug approvals without lowering its standards. More than two-thirds of drug approvals last year were completed under “priority review,” where the FDA makes an approval decision within six months instead of the standard 10 months, according to the FDA.

“The FDA is already one of the fastest regulatory agencies in the world,” says Aaron Kesselheim, an associate professor of medicine at Harvard Medical School. “Faster for faster’s sake is not wise.”

Mark Mansour, who specializes in FDA law at Mayer Brown, said Gottlieb will likely be a more “nuanced reformer” than other candidates Trump considered, according to Politico. He “won’t eviscerate the FDA,” but he could push the agency to speed up product approvals by relying more on anecdotal or real-world evidence and on data collected after a product is already on the market, Mansour said.

Gottlieb also has remained silent on drug pricing ideas that Trump pushed on the campaign trail–including direct government negotiations of drug prices in Medicare–arguing such decisions are outside the FDA’s purview.

He could still be dragged into HHS Secretary Tom Price’s efforts to address drug pricing through regulation. Price kicked off a listening tour last week as part of an HHS initiative to address drug pricing expected in the next few months. Price will meet with the main drug lobbies, PhRMA, BIO and the Association for Accessible Medicines on Friday (May 11, 2017).

Bottom Line:

It’s unclear how much President Trump will seek to oversee and command his new commissioner. If he’s smart, Mr. Trump will allow Dr. Gottlieb to rely on his FDA experience with the George W. Bush administration and the additional real-world industry knowledge gained since then to guide the agency in the general direction the White House has suggested.

Steve's Take: Will @realDonaldTrump really let Dr. Gottlieb run the show-or not? Click To Tweet

Again, if Trump is savvy with this solid appointee, he’ll let Dr. Gottlieb run the show. Qualifications–wise, he’s got what it takes to run the agency to serve the public purpose for which it was originally created. But is Trump capable of letting him do that? If not, even Dr. Gottlieb will likely join General Flynn in hearing those infamous two words.