FDA Nominee Brings Patient Care Perspective

Published November 21, 2019

President Donald Trump nominated Dr. Stephen Hahn, a prominent cancer specialist, to be the next commissioner of the U.S. Food and Drug Administration (FDA).

Hahn currently serves as chief medical executive of the University of Texas MD Anderson Cancer Center in Houston and is an expert in radiation oncology. Hahn leads a team of 20,300 employees and administers a $5.2 billion operating budget for one of the nation’s premium cancer centers.

Confirmation of his nomination by the U.S. Senate received a boost when Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-TN) said he had an excellent meeting with Hahn and believes Hahn is “well-qualified.” The confirmation hearing was scheduled to begin on November 20.

Calls for Swift Reform

Currently, it takes 12 years and $2.9 billion to bring a drug to market in the United States. FDA reform experts at The Heartland Institute, which publishes Health Care News, say they hope a leader with a strong background in cancer treatment will be open to modernizing the agency.

“We would all benefit if the new commissioner gives top priority to modernizing the FDA regulatory process in order to deliver on the primary objective of better drugs, sooner, at lower cost,” said Bartley Madden, a policy advisor to The Heartland Institute and author of Free to Choose Medicine: Better Drugs Sooner at Lower Cost.

Leaving Patients Waiting

The FDA’s slow-moving approval process is preventing the development of urgently needed drugs and other medical treatments, says Edward Hudgins, director of research at The Heartland Institute.

“Dr. Stephen Hahn, the nominee for FDA chief, needs to appreciate that the overly strict regime established in 1962 to certify the safety and efficacy of proposed medications is woefully out of date, especially in an age in which exponential technology can radically transform medicine,” said Hudgins. “Rather than shielding Americans from unsafe medications, the current FDA regime leaves tens of thousands of patients to suffer and die waiting years for drug manufacturers to jump through unnecessary hoops. Hahn should push for a full FDA reform.”

“If confirmed, having an outsider and a cancer specialist leading FDA could bring about a new, innovative perspective to the federal bureaucracy,” said Christina Herrin, director of the Free to Choose Medicine initiative at The Heartland Institute. “The FDA commissioner should advocate a patient-first approach focused on expediting approval of safe and effective drugs.”


AnneMarie Schieber ([email protected]) is managing editor of Health Care News.