Dr. Scott Gottlieb is by far the most conflicted person nominated to run the 111-year-old Food and Drug Administration. He's received payments from or invested in dozens of companies with business before the agency, earning millions of dollars in the process.
Yet he will undoubtedly be confirmed as the FDA's next commissioner after promising to recuse himself from matters involving those firms. He also promised to adhere to any recommendations from the Office of Government Ethics.
That's a joke. If the ethics office was doing its job, it wouldn't let him near the commissioner's chair for at least a year—the minimum time frame for letting a financial conflict of interest lapse—since any broad policy he approves during that time would affect some if not all those firms.
But let's set the ethical issues of the undrained swamp aside. I listened carefully to Gottlieb's testimony before the Senate Health, Education, Labor and Pensions Committee last week. Over the past decade, I've read many of the hundreds of articles that he wrote for the Wall Street Journal, the American Enterprise Institute (where he is a resident fellow), and in journals such as Health Affairs.
There can be no doubt that Gottlieb, based on his detailed knowledge about the intricacies of drug and device regulation from his two previous stints at the agency, is well-qualified to run the FDA.
But is he the right person for the job, especially given President Donald Trump's repeated promise to take steps to rein in drug prices? That's the most important issue facing healthcare providers, insurers and patients—not the speed of new drug approvals.
His most recent writings, especially on the issue of expediting generic drug approvals including biosimilars, demonstrate his thinking has evolved beyond a knee-jerk defense of the branded biopharmaceutical industry. On most key issues, however, Gottlieb's long-professed beliefs have been at odds with restricting the pricing, patent and marketing power of drug and device makers.
They are also at odds with some of his statements made during last week's hearing. So the question becomes: which Dr. Gottlieb will run the FDA?
Will it be the one who during his testimony said he would defer to the scientific judgment of the professional staff at the FDA? Or will it be the advocate who over the years repeatedly pushed to expand the boundaries of allowable medical evidence for companies seeking approvals for their new drugs and devices?
Will it be the one who testified that the opioid epidemic is the nation's No. 1 public health crisis needing an immediate "all of the above" approach? Or will it be the advocate who opposed the FDA's aggressive use of risk-mitigation strategies, which could be used to clamp down on physician overprescribing of opioids, even as he called for the FDA—not the Drug Enforcement Administration—to monitor the dispensing of opioids?
There was a whiff of hypocrisy from many of the Democrats who repeatedly blasted Gottlieb for his conflicts of interest. The 21st Century Cures Act, which overwhelmingly passed the Senate and House, gives the FDA the right to consider "real world evidence" from observational studies, not the usual randomized clinical trials. Gottlieb will soon be able to help write the rules outlining acceptable "real world evidence," which he advocated for throughout his career.
He also opposes allowing drug imports, which has also been opposed by previous FDA commissioners, and he deflected questions about Medicare negotiating drug prices, saying it wasn't within the FDA's purview. That leaves little in his toolbox for fighting high drug prices except expediting generics and biosimilars.
Will Gottlieb focus on those much-needed reforms or on quicker approvals of new drugs based on flimsy evidence? "I don't want to do anything in my conduct to reduce people's confidence in the mission of the agency," he testified. His actions will tell.
