Donald Trump is likely to soon nominate Scott Gottlieb, a physician and policy expert at the American Enterprise Institute, as the next commissioner at the Food and Drug Administration. Gottlieb edged out Jim O’Neill, a libertarian venture capitalist backed by billionaire investor Peter Thiel, for the nod.
As Gottlieb prepares for the his Senate confirmation hearings, there’s likely to be lots of interest in his public thoughts on healthcare. Here at Forbes, we’ve been lucky to count Scott among our contributors for many years. His writings here reveal the sharp mind of a man who doesn’t believe the system is fundamentally broken, but who is distrustful of bureaucracy as a solution and attuned to the way that small policy changes can have outside effects. Here are a few standouts. For some, I’ve added comments; for the others, I’ve excerpted Gottlieb’s own words.
This is one for those wondering what Gottlieb might do as FDA commissioner: he will almost certainly try to streamline the FDA’s approach with regard to “complex generics” like EpiPen, which involve, for instance, both a drug and a device. Here, he goes into detail as to how that process could be fixed.
Another problem EpiPen laid bare: the fact that most of the competition around drug prices takes place in the form of rebates that are paid to pharmacy benefit managers and employers, not consumers. In one of my personal favorites of his pieces, Gottlieb argues that this policy has roots in the way companies responded to HillaryCare decades ago.
“FDA needs to more closely focus is organizational structure and its regulatory programs on measures of risk, and move away from its structural legacy that oriented its review programs mostly around discrete clinical areas of medicine.”
“Of the many intrigues surrounding Elizabeth Holmes and her battered lab company Theranos, one of the more curious is her established support for increased regulation of her industry.”
This is the paradigmatic Gottlieb post: a small, seemingly mind-numbing change in the rules around diagnostic tests was affecting patients. So he told us about it.
Like most conservative health writers in 2013, Gottlieb was very concerned about the negative effects of the Affordable Care Act. This was one of the best of those posts: a clear explanation of how the dreaded “death spiral” might happen. As FDA Commissioner, Gottlieb would have almost nothing to do with the ObamaCare replacement.
“A spat over money for Planned Parenthood isn’t what’s holding up federal funding to fight the Zika virus. Nor are Republicans, for that matter, the ones now standing in the way,” Gottlieb wrote. “Democrats are filibustering the funding bill largely because Republicans have insisted that the legislation be ‘paid for’ with cuts in other areas of spending. Knowing it would be hard to justify blocking Zika funding over budget arcana, some critics have cast most of their protests under the guise of a fight over abortion.”
“The debate over drug pricing isn’t new. Nor is the call for importation as a way to try and circumvent some of these costs. But the evolution in these two issues reveals why the Trump plan–while perhaps good politics–will offer consumers little relief.”
“Drug companies can rarely make claims around the value of their medicines.”