Trump FDA nominee Hahn treads familiar ground on drugs, devices

By | November 22, 2019

President Donald Trump’s nominee for FDA commissioner pledged science, data and the law will be the guiding principles for decision making when faced with questions about FDA’s oversight of drugs and medical devices during testimony before the Senate HELP Committee on Wednesday.

MD Anderson radiation oncologist Stephen Hahn largely stuck to a familiar script on a gamut of issues including drug importation, FDA approval standards and encouraging competition and innovation.

Hahn told senators he would make it a priority to address drug shortages, examine anti-competitive processes used by brand drug manufacturers to protect biologics from biosimilar competition and protect the United States’ drug supply when considering drug importation.

Hahn expressed interest in boosting use of patient-focused endpoints in clinical trials for both drugs and devices.

“This is an area of particular interest to me, clinical trials,” Hahn said. “What endpoints we use could actually help expedite medical product development. We have to be pragmatic, we have to make sure that they are validated endpoints. I am interested in working with all stakeholders on this.”

On the medical device front, HELP Committee Ranking Member Patty Murray, D-Wash., blasted FDA for pressing ahead on its proposal to enact a Software Precertification Program and a progressive device approval pathway.

“I’m alarmed by changes the Trump Administration has proposed to FDA’s medical device review program including, a proposal to pre-certify software developers, and a decision to apparently break a commitment it made to me to limit a conditional approval pathway to certain animal drugs — by expanding it to human medical products as well,” Murray said.

Hahn pledged to uphold FDA’s approval standards to protect the public health, but did not specifically address the device proposals in his opening statement following Murray’s concerns.

“The FDA represents the gold standard for protecting the public health, is trusted by Americans and admired around the world for its mission ensuring the safety, efficacy and security of medical products and the safety of the nation’s food supply,” Hahn said. “I believe strongly in the importance of science, data and the law that have guided and should continue to guide the decision making at the FDA.”

Cowen’s Eric Assaraf said in a research note Hahn will likely be confirmed as the next FDA commissioner as soon as the end of the year, despite a lack of ability during the hearing to drill down on specifics.

“Hahn is no Gottlieb,” Assaraf wrote, referring to the loquacious former FDA chief Scott Gottlieb. “Still, the overall tone of the hearing was gentle, with committee Democrats largely expressing favorable impressions from introductory meetings with the nominee — and often framing questions that suggested his confirmation is a foregone conclusion.”

Hahn also pledged to work with Sen. Tammy Baldwin, D-Wis., to increase supply of medical isotope Molybdenum-99, which is used for diagnostic imaging of organs and diagnosing cancer.

“As a radiation oncologist, this is a very important compound and my personal practice experience is on the imaging side of this,” Hahn said. “I have been in clinical situations where we’ve had to delay diagnostic tests. I look forward to addressing these issues in a proactive manner.”

The nominee also supported accelerated approval of medical devices that reduce dependence on opioids that can be a potential way FDA can help address the opioid crisis.

“Based on my experience at MD Anderson a comprehensive holistic approach, often without opioids can be very helpful in treatment, including cancer pain,” Hahn said. “This is a significant problem, and what we have to do is balance the relief of suffering with making sure we prevent as much misuse as possible.”

But the hearing was not entirely controversy-free. Hahn faced a broadside of criticism from several senators on both sides of the aisle for not explicitly committing to supporting a flavor ban for e-cigarettes.

Hahn demurred when asked if he would push Trump to issue regulations banning e-cig flavors, but told Sen. Mitt Romney, R-Utah, that he was “alarmed” by data showing a widespread uptick of teenage vaping and supported “bold action.”

Prior to the hearing, Hahn garnered support from five former FDA commissioners. In a letter addressed to HELP Committee senators Tuesday, Scott Gottlieb, Robert Califf, Margaret Hamburg, Andrew von Eschenbach and Mark McClellan said the appointment of a permanent commissioner is necessary to enable FDA to sustain its work to protect the public health.

“We believe Dr. Hahn has the experience and commitment to public health and public service needed to provide this leadership,” the bipartisan group of former FDA chiefs wrote.

The nominee also has the backing from a variety of industry groups, including PhRMA and AdvaMed.

“We look forward to working with Dr. Hahn in his new role, engaging the Agency towards increasing regulatory predictability, decreasing regulatory burden, and embracing the digital transformation of the biopharmaceutical industry,” PhRMA said in a statement.

AdvaMed told MedTech Dive it hopes Hahn will have an “expeditious confirmation.”

“Dr. Hahn’s distinguished career as a health care provider and researcher gives him a unique perspective on the importance of patient access to the latest medical advances,” AdvaMed said in a statement.

Senate HELP Committee Chair Lamar Alexander, R-Tenn., said the committee will vote on Hahn’s nomination Dec. 3. It is unclear whether Democrats or Republicans will vote against Hahn with FDA currently operating under its second acting commissioner since Gottlieb left the agency in April, which some advocates argue weakens its ability to act as effectively.

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