Author:Riggs, Mike

IT'S MID-DECEMBER, AND Scott Gottlieb is at the Harvard Club. The Manhattan Institute has invited a few dozen people for an intimate discussion about what's happening at the Food and Drug Administration (FDA). As they eat finger foods and sip cocktails, a relaxed Gottlieb meanders around the room sans entourage and snags the occasional pretzel stick from a platter. As a former think tanker himself--he was an American Enterprise Institute resident fellow for roughly a decade--these are his people. Everyone takes their seats. Gottlieb's old friend Peter Huber, an attorney and senior fellow at the host institute, is sitting right up front. Just a few years earlier, the two had partnered to argue the affirmative in a debate over whether "the FDA's caution is hazardous to our health." But now that Gottlieb is the head honcho at the agency, some libertarians who once considered hima fellow traveler are finding him a tough nut to crack.

When the floor opens for questions, one is about his plan to require cigarette manufacturers to lower the nicotine in their products to a "minimally or non-addictive level."

"You want to take the nicotine out of cigarettes," the audience member says, incredulous. "Do you also want to take the alcohol out of booze?"

"The FDA does not regulate alcohol products," Gottlieb responds.

"Well, thank God for that," the questioner says, before plopping into his seat.

The exchange demonstrates just one of the ways in which Gottlieb is not the person many onlookers anticipated. When Trump nominated him to be FDA commissioner in March 2017, conservatives and libertarians applauded his record of advocating market-based health care reforms, while liberals bemoaned his financial ties to the pharmaceutical industry and predicted death and destruction.

They were both wrong. Instead of a radical deregulator, he has turned out to be a cautious institutionalist, focused on ensuring that his agency lives up to its obligations without exceeding the limits of its authority. Yes, he is nudging the FDA toward streamlining its approval process and encouraging competition in the drug and device markets. But Gottlieb was never going to burn the FDA to the ground, and people who thought he would weren't paying attention to what he's been saying all along.


"SCOTT GOTTLIEB'S FERVOR for deregulation could harm patients," warned a piece published on the health news site STAT shortly after his appointment. "Farewell to drug regulation? Trump nominates a 'bona-fide pharma shill' to head the FDA," complained a Los Angeles Times headline.

Gottlieb really is a longtime critic of the agency. At the Manhattan Institute, he speaks with the same polish he's demonstrated in hearings before Congress, repeating some of his favorite mantras: The FDA needs to "think differently" when it comes to biologic therapies and medical apps; "speed vs. safety" is a false choice the FDA doesn't have to make. At times he seems to channel a seminal 2012 essay he penned for National Affairs, titled "Changing the FDA's Culture," in which he bemoaned the agency's "excessive desire for certainty" and its "mistrust of the doctors who eventually prescribe medicines and the companies that market them."

Gottlieb has argued repeatedly for reforming the way the FDA handles many of its duties, in particular the approval pipeline for drugs and medical devices. His criticisms were rooted in experience: He worked for the agency twice during George W. Bush's presidency, first as a senior advisor to Commissioner Mark McClellan and then as the deputy commissioner for medical and scientific affairs under Commissioner Andrew C. von Eschenbach. And like nearly every FDA commissioner before him, he has practiced medicine, as an internist and faculty member at the New York University School of Medicine.

He also has extensive experience working with the drug companies he's now tasked with regulating. The federal disclosure form he filed with the U.S. Office of Government Ethics after his nomination listed board positions at Tivorsan Pharmaceuticals, Tolero Pharmaceuticals, GlaxoSmithKline, Glytec, and Daiichi Sankyo U.S., as well as consulting fees related to work at Bristol-Myers Squibb, Vertex Pharmaceuticals, and various investment firms.

All of which made him a prime target on the left. At his confirmation hearings, Senate Democrats suggested that elements of Gottlieb's background--particularly his corporate ties--disqualified him for the job. They depicted him as a crony for the drug industry, hell-bent on stripping the agency of its regulatory powers. Sen. Elizabeth Warren (D-Mass.) read aloud a passage from the National Affairs piece suggesting the agency had over-corrected in response to the thalidomide crisis, in which a sedative given to pregnant women in the 1950s as an off-label treatment for morning sickness resulted in thousands of babies being born with deformed limbs and other congenital disorders.

In his essay, Gottlieb argued that the scandal, which didn't reach U.S. shores thanks to concerns raised by an agency employee named Frances Kelsey, "fostered an idealization of the lone reviewer championing an issue of safety against the prevailing orthodoxies, especially when it meant taking on corporate interests." That is a core part of the agency's mission, of course--but the downside of a purely oppositional attitude is that the agency "has sometimes subordinated and neglected its other key obligation, which is to guide new medical innovations to market."

Gottlieb dedicated more than 5,000 words to reconciling these two obligations without denigrating the FDA or dismissing the severity of the thalidomide error. Warren was less charitable. She read aloud 22 of his words--the part about taking on corporate interests--and then lobbed this question: "Dr. Gottlieb, do you think the FDA puts too high a priority on championing safety and unborn babies?" (He dodged, noting that the "modern FDA does a very good job of ferreting out risk preclinically.")

Many folks on the right likewise assumed that upon taking office Gottlieb would implement the suggestions he had outlined in National Affairs, which ranged from demolishing some of the obstacles the FDA has erected to prevent U.S. patients from accessing drugs sold in Western Europe to relieving junior review staff of the burden of making decisions that are above their pay grades. Some libertarians likely hoped he would upend the entire clinical trial process, approving...

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