Here is the FDA’s New Commissioner: Stephen Hahn

A cancer doc is now FDA Commissioner.

The U.S. Senate confirmed Stephen Hahn, M.D., on December 13, 2019 on a 72-18 bi-partisan vote.

Hahn is a radiation oncology expert and was recently the chief medical executive of the University of Texas MD Anderson Cancer Center in Houston. He’d been a professor of radiation oncology at the Center since January 2015. Before MD Anderson, he was at the University of Pennsylvania.

Senators reportedly pressed Hahn that he would put science, data and public health over politics, and be willing to stand up to the president as well as large corporations with significant lobbying power. His hearing addressed opioids, drug pricing and generics, but the main focus was on vaping.

Industry and Professional Support

Hahn had the support of AdvaMed, the medical device industry’s top lobbying group, several physicians and research organizations and five previous FDA commissioners. The American Association for Cancer Research (AACR) commended the Senate for confirming Hahn. Hahn has been a member of AACR since 1999.

While not brandishing normal Washington, D.C. political experience, Hahn is no stranger to healthcare politics while leading the MD Anderson Cancer Center in a financial turnaround.

Hahn reportedly told Senators that running an academic medical center is similar to running a government agency.

He said both are “big complex, public-health-driven, research-driven organizations.” MD Anderson employs about 21,000 people. The FDA has about 17,000 workers.

Views on Approval Process

As a clinical trialist, he offered senators his views on modernizing the FDA approval process.

He said he is interested in reconsidering what endpoints are used in clinical trials and discovering new ways to expedite the product-approval process, with the understanding that “those approaches are validated” and the current gold standard of the product review process is upheld.

“In the new era where science is moving so quickly, the agency should be more efficient, and we should have more agility,” Hahn said.

AdvaMed issued this statement: “Dr. Hahn is an excellent choice to lead FDA, and we congratulate him on his swift and overwhelming bipartisan confirmation. During the confirmation process, Dr. Hahn demonstrated his deep understanding of the agency’s mission to protect and promote the public health and the role of innovation in improving patient care. His background as a physician, researcher and administrator will serve the American people well at this vital agency. We look forward to working with him on behalf of the patients our industry serves.”

4th FDA Commissioner Under Trump

How long will this one last? Dr. Hahn is the fourth FDA Commissioner under Trump. The first, Scott Gottlieb, M.D., stepped down in April and was replaced by acting commissioner Norman Sharpless, M.D. Last month, Sharpless returned to his previous post as director of the National Cancer Institute, and Brett Giroir, M.D., a top official at the Department of Health and Human Services, succeeded him as acting FDA commissioner.

Hahn is reportedly a longtime Republican donor, backing all of the Republican presidential nominees dating back to Mitt Romney. He did not support Trump. Don’t tell the White House.