On Wednesday morning, the United States Senate Committee on Health, Energy, Labor, and Pensions conducted the confirmation hearing for Dr. Scott Gottlieb, President Trump’s nominee to be the next Commissioner of the Food & Drug Administration (FDA). In a presidential administration whose confirmation hearings have sparked more than a few contentious moments, Dr. Gottlieb’s hearing was remarkable for how unremarkable it was. Senators from both parties asked questions on the full range of the FDA’s jurisdiction, and Dr. Gottlieb’s experience combined with his clear preparation for the hearing resulted in an uneventful, two-and-a-half hour hearing.
But to say that Dr. Gottlieb’s hearing was uneventful is not to say that it was uninteresting. In my view, Dr. Gottlieb was asked about four categories of issues that are worth considering for insight into how is he is likely to lead the agency. Further, he was not asked about a fifth issue that in my view is critically important for the next commissioner.
The FDA’s New Drug Approval Process
First and perhaps most importantly, the issue of the FDA’s process and standards for approving new drugs played a central role in the hearing. Dr. Gottlieb mentioned it even in his opening statement, urging Congress to reject the “false dichotomy that it all boils down to a choice between speed and safety.” He was asked repeatedly about this idea by Senators on both sides of the aisle, and in doing so he aimed to strike a balance. On the one hand, he made it clear that he recognized the importance of the “gold standard” of FDA review. On the other, he encouraged the FDA to “lean forward” and modernize and speed the regulatory process, where appropriate.
Dr. Gottlieb’s answers were likely unsatisfying to both parties. In answering Senators who may be more antagonistic toward the FDA and its basic mission, Dr. Gottlieb refused to adopt some of the talking points of some of the other people who were floated for this position; he declined to say that he would eliminate steps of the process entirely, or that he would approve drugs based only on safety (although it’s not clear what that means), for instance. But at the same time, it did not seem that he was using the term “gold standard” to refer to the FDA review process as it has existed in recent years. He lauded the importance of the idea that FDA review is the “gold standard,” but simultaneously discussed the importance of speeding review in particular therapeutic areas or weakening randomization protocols in some cases. Based on Dr. Gottlieb’s voluminous record, this is to be expected, but I will be watching to see how it plays out in practice.
The Character Of The FDA
Second, Dr. Gottlieb was asked a series of “what would you do in this situation” questions which provided him the opportunity to affirm the role of the FDA as an agency dedicated to the preservation of public health, as an agency driven by the science, and as an agency driven by the career staff, not the political appointees. His responses to these questions ranged from heartening to downright inspiring (to this public health advocate, at least), although I recognize that it is perhaps a commentary on the rest of the administration, not on Dr. Gottlieb, that his emphatic, clear denial of the suggestion that vaccines may cause autism will make headlines. Relatedly, he also took several of these opportunities to emphasize the importance of consumer trust in the FDA, and to note that his management of his many conflicts of interest would keep that trust in mind.
The Opioid Epidemic
Third, Dr. Gottlieb was asked about perhaps the most important substantive challenge facing the agency: the opioid epidemic. He emphasized that the issue would be his highest priority upon being confirmed, and that he considers it to be a “public health emergency” on par with Ebola and Zika. Some Senators whose states have been devastated by the opioid epidemic may believe that analogy understates the opioid crisis. However, the key point is Dr. Gottlieb’s statement that a non-communicable problem like opioid addiction can be meaningfully compared to the more traditional challenges the public health community has faced in the communicable disease area.
Fourth, Dr. Gottlieb was asked a number of questions about another pressing policy issue: drug pricing. He was able to fall back on the scope of the FDA’s jurisdiction in some cases, which allowed him to less than fully answer some of the more politically difficult questions. Because the FDA is not permitted to take the price of drugs into account in the approval process, and because the agency has little direct authority over pricing, its power here is limited.
But the agency also plays an integral role in maintaining the regulatory barriers that in some cases keep prices high. Dr. Gottlieb made clear that he appreciated this fact, distinguishing between two different cases of high-priced drugs: First, there are those like Martin Shkreli’s Daraprim, whose high price is enabled because of the barrier to entry created by required FDA approval of generics. Dr. Gottlieb believes that this is a “solvable problem,” and we can expect him to work toward addressing it as commissioner. Second, however, there are more complex generics which are genuinely difficult for manufacturers to produce. This is a more difficult problem, one for which the agency will need to consider its role in both creating and solving.
FDA’s Relationship With Other Agencies
Fifth and finally, at no point was Dr. Gottlieb asked explicitly about the relationship between the FDA and other administrative agencies, but he should have been—particularly about the FDA’s relationship with other agencies also within the umbrella of the Department of Health and Human Services (HHS). Several of the questions Dr. Gottlieb was able to avoid as being outside the FDA’s purview, including a number about the Affordable Care Act and Essential Health Benefits, could have been reconstructed as involving collaboration between the FDA and other agencies, including the Centers for Medicare and Medicaid Services (CMS) and HHS.
Of course, the FDA is in charge of the regulation of medical products, rather than physician services. But the two are integrally related, and Dr. Gottlieb knows that. To address the opioid epidemic, he will need not only to change the way in which these products are regulated—he will need to change the way in which they are prescribed by physicians, dispensed by insurers and pharmacists, and used by patients. And for that he will need help. I can only hope that he and other administration officials work together as clearly and publicly as FDA Commissioner Robert Califf and CMS Administrator Andy Slavitt did under President Obama.
The FDA certainly faces a series of difficult policy challenges ahead, and there will undoubtedly be other problems that arise, including as a result of the chaos in the administration itself. But in his hearing, Dr. Gottlieb successfully presented himself as a smart, thoughtful expert who appreciates the importance of the agency he is being appointed to lead. Although concerns over his conflicts of interest remain, I expect Dr. Gottlieb to be confirmed easily.