FDA Commissioner nominee weighs in on drug pricing, vaping and opioids during confirmation hearing

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Ben Comer Senior Manager, Health Research Institute, PwC US November 21, 2019

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During his Senate confirmation hearing Wednesday, Dr. Stephen Hahn, President Donald Trump’s nominee to lead the FDA, said he was “open to all science and data that could potentially support drug importation,” while acknowledging the importance of assessing the safety and security of the nation’s drug supply.

Hahn, a radiation oncologist and chief medical executive at MD Anderson Cancer Center, fielded questions on hot topics from members of the Senate health committee for several hours. He weighed in on vapor and e-cigarette regulations, opioid prescribing practices, hemp and cannabidiol (CBD) regulations and food labeling, over-the-counter (OTC) monograph reform, expedited approvals of biosimilars and insulin products, the use of big data and advanced analytics, and FDA staffing issues.

On drug pricing, Hahn said the FDA can do “indirect things” such as stimulating innovation, adding that “not a week goes by” that a patient doesn’t refer to the “financial toxicity” of certain drugs. He also emphasized the importance of the biosimilars pathway and making sure that insulin is transitioned to the biologics and biosimilar review process successfully in 2020.

Hahn acknowledged that the OTC monograph process may need an update. He said the FDA’s role in preventing drug shortages and expediting the development of antimicrobial drugs is critically important. He called for a framework for assessing CBD products and spoke in favor of clear, transparent food labeling.

Hahn also described mental health as a particular area of interest. “As a clinical trialist, endpoints [in mental health and neurodegenerative diseases] are critical,” he said. “We need to be pragmatic, but we also need validated endpoints.”

He expressed his “deep respect for Congress,” which prompted a rejoinder from Sen. Mitt Romney, a Republican of Utah, who joked that Hahn’s respect for Congress “calls into question your judgment.”

If confirmed, Hahn will replace Dr. Brett Giroir, HHS assistant secretary for health, who has been handling the delegable duties of the commissioner role in recent weeks. Dr. Norman Sharpless was the previous acting commissioner following Dr. Scott Gottlieb’s departure from the agency in April. Sharpless has returned to the National Cancer Institute, where he is director.

HRI previously reported Hahn’s long career in radiation oncology, including positions with the National Cancer Institute, the University of Pennsylvania’s Perelman School of Medicine, and the MD Anderson Cancer Center in Houston. Hahn has been the chief medical executive at MD Anderson Cancer Center since 2018. He also co-founded Liquid Biotech USA, a cancer diagnostics company, with colleagues from Penn.

The issue of talent and staffing at the FDA was raised by several senators. Hahn told the committee that the FDA needs agility and the ability to get the right people into the agency. Asked how he would improve hiring, he said that he would make implementation of the 21st Century Cures Act a priority and that “the experience I’ve had at MD Anderson in recruiting and retaining the best and brightest will help at FDA.”

“New and improved ways of evaluating data will allow the FDA to expedite innovation, better evaluate new products and ensure food safety with even greater accuracy and certainty,” said Hahn. “All of this, however, requires that FDA has the appropriate talent, expertise and infrastructure to keep up with the science and technology,” he said.

Only Sen. Patricia Murray, a Democrat of Washington, expressed reservations about Hahn’s background and experience, including “almost no government experience, no public record on policy issues related to the FDA, and no experience leading an organization anywhere near as complex as the FDA.” Still, other senators drew comparisons between the FDA to MD Anderson, noting they have similar numbers of employees and budgets.   

On opioid use and prescribing practices, Hahn said he would continue the agency’s work on revised packaging and labeling of opioid products and would encourage the approval of non-opioid products and medical devices for pain management.

He did not take a strong position on the ban on flavored vapor cartridges, which was proposed by the Trump administration in September but delayed earlier this month, according to The Washington Post.

In response to several questions, Hahn did not explicitly support the ban and said that he wanted to reserve judgment, citing a compliance policy currently under consideration, and that he would need to review all of the data. But he also said: “I’m a lung cancer doctor. It’s all too real to me. I believe we need to take aggressive action.”

Throughout the hearing, Hahn emphasized his commitment to making decisions based on data and science, in congruence with the law, and putting patients’ best interests first. He said he would be guided by the core values of integrity and transparency, and reiterated that commitment when faced with questions about political, corporate or ideological pressure placed on FDA policymaking.

“In my career, there have been situations where recommendations have been made that weren’t in the best interest of patients,” he said. “I am deeply, deeply committed to my patients and the public health of patients in this country. I will stand up for that.”   

The health committee is expected to make its recommendation on Hahn to the full Senate in December.

HRI impact analysis

If confirmed as FDA commissioner, Hahn will manage national questions around the agency’s regulation of e-cigarettes, potential widespread medical device shortages due to closures of sterilization facilities, and new applications of artificial intelligence in medical devices. These initiatives are in addition to the FDA’s ambitious regulatory agenda for 2020 and continued implementation of the 21st Century Cures Act.

Pharmaceutical and life sciences industry onlookers were not likely surprised by any of Hahn’s responses during the Senate health committee hearing, and it appears probable that he will be confirmed as the next FDA commissioner. Five former FDA commissioners offered their support for Hahn in a Nov. 19 letter published by Politico, and Sen. Lisa Murkowski, a Republican of Alaska, pledged her support during the confirmation hearing.  

Additionally, the American Society for Radiation Oncology and other professional groups, as well as Senate health committee Chairman Lamar Alexander of Tennessee, supported Hahn’s nomination because of his firsthand knowledge of the importance of providing innovative, lifesaving drugs and devices through regulatory processes.

Drug industry executives, while potentially concerned about Hahn’s comments on drug importation during the hearing, may have also been pleased to hear that he will focus on indirect actions, such as “stimulating innovation,” as a tool to bring down drug prices.

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Ben Comer

Senior Manager, Health Research Institute, PwC US

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

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