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April 11, 2017

Senate Holds Confirmation Hearing on Gottlieb

Scott Gottlieb MD WWSG Hi-Res Photo

On April 5, 2017, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a confirmation hearing on the nomination of Scott Gottlieb, M.D. to serve as Commissioner of the Food and Drug Administration (FDA). Members of the committee engaged Dr. Gottlieb on the agency’s role in addressing opioid abuse. Chairman Lamar Alexander of Tennessee said the Committee would vote on Dr. Gottlieb’s confirmation after the Easter recess.

During opening statements, Chairman Alexander called for quickly moving FDA user fee reauthorizations before Aug. 1. He said he is concerned with the Administration’s hiring freeze and its implications for the FDA, especially because the 21st Century Cures Act sought to bolster FDA staffing resources.

Ranking Member Patty Murray called for strong, independent leadership of the FDA and said Dr. Gottlieb has “unprecedented financial entanglement with industry.” She said she is concerned about potential ideologically driven decision-making, citing Bush Administration policy on women’s access to Plan B. She said she wants to hear Dr. Gottlieb’s plans for increasing competition through generics and biosimilars and reducing drug costs.

In his testimony, Dr. Gottlieb noted that he appreciates the agency’s work as both a doctor and a cancer survivor. He emphasized that he respects congressional intent and expressed desire to: assure timely implementation of laws, adhere to scientific rigor, and heed guidance from career staff. He said the agency must “lean forward” in implementing 21st Century Cures and that it is a “false dichotomy that everything is a balance between speed and safety,” adding that both are possible while adhering to “gold-standard regulatory conduct.”

Question and Answer Period

The question and answer period of the hearing was extensive, with conversation about many hot topics, including the hiring freeze, opioids, and conflicts of interest.

Hiring Freeze

In discussion with Chairman Alexander, Dr. Gottlieb said he understands how critical FDA personnel levels are and that it is “incumbent on us to have a world-class workforce.” Dr. Gottlieb said he has spoken out on staffing levels and will make it a priority. Chairman Alexander said he wants to make 21st Century Cures “a reality and [staffing and hiring] is an important part of it.”

Opioids

Opioid abuse was by far the most frequently raised and discussed issue of the hearing. Chairman Alexander asked about non-addictive painkillers, noting such options might be able to stem opioid abuse. Dr. Gottlieb said the epidemic has “staggering consequences” and will require an “all-of-the-above” approach, including “dramatic action.” He said that includes new alternatives, including device-based interventions and medication-assisted therapy (MAT).

Senator Tim Kaine discussed opioids with Dr. Gottlieb when Dr. Gottlieb said he would have a “bipartisan mandate” on finding the right framework for opioid policies and that opioids would be his “highest immediate priority.”

Conflicts of Interest

Dr. Gottlieb said he had thoroughly complied with Office of Government Ethics procedures and was committed to a “front office” process to mediating any ongoing concerns, including recusals. Senator Murray and other Democrats expressed numerous concerns about Dr. Gottlieb’s role in venture capital and as a board member and investor in various industry entities. Dr. Gottlieb said he is committed to earning the public’s trust.

Dr. Gottlieb has filed an ethics agreement stating that he will recuse himself for one year from any agency decisions that involve more than twenty health companies he has been connected to.

Biosimilars

Senator Mike Enzi asked Dr. Gottlieb about the status of approval of biosimilars. Dr. Gottlieb said there is an opportunity for “meaningful savings,” including through interchangeability. He expressed a need to get final interchangeability guidance out.

Competition and Reimportation

Senator Bernie Sanders asked about Dr. Gottlieb’s position on reimportation of drugs from Canada and cited Dr. Gottlieb’s writings on the approach not addressing “core challenges.” Dr. Gottlieb said he has other ideas on how to promote competition and that many of his articles may address subjects falling outside the FDA’s purview.

Trial Design

Responding to Senator Tim Scott, Dr. Gottlieb said he would encourage the use of better tools for getting products to market quickly. He pointed to Cures as a template, including “not just adaptive trial designs but modeling and simulation.” Senator Elizabeth Warren discussed the example of Thalidomide as illustrating the risks of prioritizing treatment over consumer protection. She questioned Dr. Gottlieb about his views on this balance and her concerns.

Senator Bob Casey asked about the role of Phase III trial data, saying Dr. Gottlieb had been critical of reliance on such results. Senator Casey said some safety issues arise only at that juncture. Dr. Gottlieb said it may be possible to compress Phase II and III into a larger adaptive design. He said a “proper clinical program is an essential feature and proper post-market enforcement tools are important.”

Industry Oversight

Senator Tammy Baldwin expressed concern with drug industry attempts to extend market exclusivity and engage in “misleading” direct-to-consumer advertising. Dr. Gottlieb said the FDA is designed to promote public health and not to engage in commercial disputes. He said he wants a “framework that prevents regulatory process’ use as commercial arbitrage.”

Conclusion

As noted above, the vote on whether to confirm Dr. Gottlieb won’t happen until the Senate gets back from Easter recess. However, Gottlieb has been endorsed by the National Consumers League, the National Coalition for Cancer Survivorship (he is a survivor of Hodgkin’s Lymphoma), the Global Healthy Living Foundation, the Alliance for Aging Research and by former FDA Commissioners Margaret Hamburg, Robert Califf, and Mark McClellan. It is likely that he will also be approved by the Senate to run the FDA, though it is likely that his appointment will fall along party lines in highly-partisan Washington, D.C.

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