FDA Nominee Grilled about Agency’s Drug Approval Process

Published December 17, 2019

At his initial confirmation hearing before the Senate Health, Education, Labor, and Pensions Committee, Stephen Hahn, President Donald Trump’s nominee to head the Food and Drug Administration (FDA), was told senators want him to speed up the agency’s drug approval process.

Sen. Mike Braun (R-IN) asked Hahn how open he was to reform.

“I think it’s important to expedite and reach patients as quickly as possible,” Hahn answered. “I do want to ensure these approaches are validated, to avoid huge mistakes that hurt patients, but I am open to a conversation about that.”

Braun responded, “Rest assured, before confirmation I’ll be getting with you on that.”

Sen. Johnny Isakson (R-GA) told the nominee he wants the FDA to speed up approvals.

“I share your enthusiasm for modernizing the approval process,” Hahn said. “As a physician, I rely on the FDA for protecting patients, and the standards cannot be compromised. However, I believe in a new era, when the science is moving so quickly, the agency should be more efficient, and we should have more agility with those approvals.

“Part of that is, in fact, getting the right people in place to make the assessments that are needed to uphold the gold standard,” Hahn told the committee.

The Senate committee approved Hahn’s nomination in an 18-5 vote. A vote by the full Senate is expected in December. Hahn would replace Scott Gottlieb, who served as FDA commissioner for the past two years.

Systemic Problems

Ed Hudgins, director of research at The Heartland Institute, which publishes Health Care News, says it is notable “the gold standard” came up again in the hearing, this time by Sen. Patty Murray (D-WA), who defined it as placing science before politics.

“The gold standard is turning to rust, and patients are suffering and dying while waiting for promising medications delayed for years by the increasingly antiquated system,” said Hudgins. “Even worse, proposals to actually put patients first and revamp the system are falsely portrayed as ‘loosening’ science standards.”

Hahn told the committee he agreed with Murray and pledged to put patients first. Hudgins says the FDA’s requirements for certifying the safety and efficacy of new medicines and treatments, established by Congress in 1962, stand in the way of that promise.

“The standard is behind the times and hampering medical innovations based on scientific advances and exponential technology,” said Hudgins.

 Hudgins says it would have been more encouraging if Hahn had acknowledged that problem.

“Rather than giving more power to the FDA bureaucracy, Hahn should expose how the current system stifles innovation and takes away patient choice, if he wants to put patients first,” said Hudgins.

Open to Analytics

While discussing potential reforms at the hearing, Hahn said he was open to new ways of using data.

“Data analytics [could] help us come to more accurate and precise conclusions about products,” said Hahn. “Those are two things I’d like to see, if confirmed, pushed forward at the agency.”

Problems with the FDA’s drug approval process have existed for decades. Currently, it takes 12 years and $2.9 billion to bring a drug to market in the United States. Although the FDA commissioner has limited jurisdiction over the prices patients pay at the pharmacy, high drug prices reflect the extraordinary time and expense involved in getting new drugs approved by the agency.

Focused on Drug Prices

The high cost of prescription drugs was another important subject of inquiry at the hearing. Hahn told the committee he wants to encourage competition in the market, but he could not commit to supporting a policy of importing drugs from other countries.

Asked by Sen. Tammy Baldwin (D-WI) about his views on lowering drug prices, Hahn said, “I don’t spend a lot of time on the price side. But rarely a day goes by that this isn’t an issue addressed by patients. It’s an urgent issue, and the American people want us to act on this. Ultimately, this is an access issue.”

Asked about the safety of lower-cost generic drugs, Hahn said he would encourage adherence to manufacturing standards and improvements in manufacturing practices.

Several senators said they wanted the FDA to focus on the development of biosimilars and other generic drugs while tackling “patent gaming,” the practice of pharmaceutical companies blocking generic drug makers’ access to product samples needed to create generic drugs, and the use of legal loopholes to extend patents.

“I am very much in favor of transparency, and anti-competitive practices should be eliminated,” Hahn told the committee.

Hahn, a radiation and medical oncologist, has served as chief medical officer at the University of Texas MD Anderson Cancer Center in Houston since May 2018. In that capacity, he oversees 20,300 employees and administers an annual operating budget of $5.2 billion.


Bonner R. Cohen, Ph.D. ([email protected]is a senior fellow at the National Center for Public Policy Research and a senior policy analyst with the Committee for a Constructive Tomorrow.