Nominee for FDA Commissioner Vows to Strike Balance Before Senate Panel

Scott Gottlieb, MD, President Donald J. Trump’s nominee for FDA Commissioner, testified before the Senate Committee on Health, Education, Labor & Pensions at his confirmation hearing today that he would be an impartial and passionate advocate for public health. In his opening statement, he said that he would seek the most “bang for our regulatory buck” while being cognizant of risks and being sure to not add to consumer costs without improving consumer safety. He stressed his belief in the “gold standard of safety and efficacy” at the agency and said he hopes to expand approvals of generic drugs to lower US drug prices. “I think there are ways to modernize clinical studies without sacrificing the gold standard,” Gottlieb said.

A fellow at the American Enterprise Institute and former deputy commissioner of medical and scientific affairs at the FDA, Gottlieb has held senior posts at the CMS under former President George W. Bush. He has expressed opposition to many FDA regulations, including FDA efforts to regulate diagnostics that could impact innovation. During the 2016 Patient-Centered Oncology Care meeting hosted by The American Journal of Managed Care®, Gottlieb discussed possibilities for repealing and replacing the Affordable Care Act, including fewer restrictions on what he called “very tight actuarial banding” that “doesn’t allow for experimentation in benefit design.”

Gottlieb has been involved in venture capital and investment banking firms that invest in biomedical startups, and has his own consulting firm. He has served on numerous boards of pharmaceutical companies, which has helped him gain the support of pharmaceutical industry leaders but simultaneously raised concerns among critics worried about conflicts of interests. Gottlieb has vowed to recuse himself from issues related to the nearly 2 dozen companies he has ties to, and said he would divest himself of medical company stocks and would resign from his other positions.

As a Forbes contributor, Gottlieb has written about streamlining the generic drug approval process and has advocated the end of drug rebates as a way to lower drug prices. “If insurers could demand up-front discounts, rather than back-ended rebates, and drug makers were free to offer them, then more of the markdown would come in the form of lower opening prices,” he stated in a September 2016 column.

In response to questioning from Senator Patty Murray of Washington about whether the FDA under Gottlieb would exercise independent, science-based decision making, Gottlieb said that would be his goal because people’s lives were at stake. “I’ll be guided by the science and by the expertise of the career staff,” he said. Murray noted Gottlieb’s financial ties to companies that she said have 60 drugs that could come before the FDA. When asked by Senators if he would resist FDA staffing cuts proposed by President Trump, Gottlieb said, “I’m going to be committed to advocate for a strong FDA, for strong resources at the FDA,” and said he hadn’t been shy about expressing his views to bosses.

Gottlieb said his first priority as FDA Commissioner would be findings ways to fight the opioid crisis, which required dramatic action. He called for reevaluating the way FDA currently develops alternatives to opioid drugs, and how the agency views medical devices and medically assisted therapy for people struggling with addiction.