Feature

Some experts, lawmakers concerned about Hahn’s agenda as FDA commissioner

In an 18 to 5 vote earlier today, the Senate Health, Education, Labor and Pensions Committee sent the nomination of Stephen M. Hahn, MD, as the next FDA commissioner to the full Senate.

Hahn, chief medical executive and professor of radiation oncology at the University of Texas MD Anderson Cancer Center, had pledged during a hearing before the committee last month to be impartial on all FDA matters, such as the lung injuries tied to vaping, the opioid epidemic and the drug approval process.

“There are many issues that will come before the commissioner that are complex and engender honest disagreement,” Hahn said. “When that occurs, I pledge to listen, study and assess all viewpoints.”

However, after President Donald J. Trump backed off the idea of banning flavored e-cigarettes, some experts and lawmakers are concerned that Hahn will not commit to the ban if confirmed.

E-cigarette 
Lung injuries tied to vaping were one of several topics that Scott Hahn, MD, was asked about during a Senate committee hearing last month.
Source: Adobe

Healio Primary Care spoke with several experts about Hahn’s qualifications, his possible agenda and to what extent the president may influence FDA public health policy.

Hahn’s qualifications

If Hahn becomes the next FDA commissioner, it will be his first job in public service. Conversely, the previous five commissioners — Scott Gottlieb, MD; Robert M. Califf, MD; Margaret Hamburg, MD; Andrew C. von Eschenbach, MD; and Mark McClellan, MD, PhD — had some previous experience working in government agencies before becoming the FDA’s top official, according to their biographies on the FDA’s website.

Joshua M. Sharfstein, MD, a former deputy FDA commissioner under President Barack Obama, said in an interview that it is hard to find someone 100% qualified for the position.

“Nobody is entirely prepared to be FDA commissioner,” said Sharfstein, who is now a vice dean at Johns Hopkins Bloomberg School of Public Health. “It’s a very difficult job under the best of circumstances, and I certainly wish him the best.”

Michael B. Siegel, MD, professor at the Boston University School of Public Health, explained that government experience is not “absolutely necessary” for the job.

“Hahn understands the need to develop mechanisms to make cancer treatments available to patients as quickly as possible while still maintaining high standards for patient safety. If he applies this principle, he could make a major contribution to improve the availability of critical medications, while ensuring their safety.”

Robert Freeman, PhD, a former professor of pharmacy administration at the University of Maryland's Eastern Shore campus, pointed to Hahn’s “excellent research credentials, meaning he has significant managerial experience at the university level.”

“Commissioners set policy direction and leave the logistics of carrying out his/her directives to the career officers,” Freeman said in an interview. “As far as leadership is concerned, he's demonstrated the kinds of qualities you would want to see for this position.”

Others also saw Hahn’s background, which includes awards from, or memberships in, at least a dozen medical societies, and co-authorship of more than two dozen research papers, as a positive.

“Experience within the FDA would be valuable, but Hahn is a top-flight researcher, which means he has a lot of experience in dealing with FDA issues,” Arthur Caplan, PhD, founding head of medical ethics at the New York University School of Medicine. “His scientific and administrative pedigree counts for a lot in terms of qualifying experience.”

However, Raymond March, PhD, research fellow at the Independent Institute — a California-based think tank — and director of FDAReview.org, told Healio Primary Care it is “critical” that FDA commissioners have leadership experience at agencies with regulatory power. He is not convinced Hahn is the best fit for the job.

“Hahn is an established oncologist and strong cancer researcher but has little government experience and comparatively less research and leadership experience than others who were being considered,” March said. “That he was chosen over what I believe are more qualified candidates tells me cancer research is being put ahead of other considerations. I view this largely as a political move by the current administration.”

Hahn’s stance on vaping in question

Sen. Patty Murray, D-Wash., a member of the Senate committee who voted against Hahn’s nomination, also expressed concern about his lack of experience, but she said she was more concerned about Hahn’s stance on vaping.

“I’m not convinced Dr. Hahn is the right pick for the job,” she said today. “While I have been skeptical of his experience and public record on FDA policy issues or his experience leading an organization as complex as the FDA, I was particularly concerned that when pressed several times by members on both sides of the aisle, Dr Hahn refused to commit to implement a strong policy to clear nontobacco flavored e-cigarettes from the market,” Murray said.

Even Sen. Mitt Romney, R-Utah, who voted in favor of Hahn’s nomination, said at today’s hearing that he had “some degree of concern” regarding Hahn’s position on vaping.

“I had hoped ... that he would place the interest of public health above any other interest, including political interest,” Romney said. “And that if for some reason he was directed to take action that was contrary to his view as a professional, and as a scientist and as a doctor, he would clearly state that he was directed to do so and would consider resignation.”

During last month’s committee hearing, Hahn pledged to work with Congress on several issues, including making more generic drugs available, lowering drug costs and coming up with solutions to end the opioid crisis.

But the recent spate of vaping-related lung injuries and children’s access to e-cigarettes took up most of the last month’s hearing. Sources agreed that Hahn needs to make combustible cigarettes and vaping one of his top priorities.

Sharfstein said the next commissioner “should implement the vision set out by Gottlieb, particularly around reducing nicotine levels in combustible cigarettes and regulating e-cigarettes to be less attractive to use.”

Siegel, who has researched various forms of cigarettes for more than 2 decades, hoped that Hahn will take a more balanced approach toward combustible and e-cigarettes.

“The Center for Tobacco Products has become obsessed over e-cigarettes to the point of being prepared to wipe out an entire industry, while having done literally nothing about cigarettes, the leading cause of preventable death in the United States,” he said. “Hahn’s first priority should be to recommit the agency to ending the smoking epidemic once and for all.”

March, who wants Hahn to focus on lowering prescription drug prices, expressed concern that little will change in terms of e-cigarette regulations.

“Few FDA commissioners have successfully navigated these controversial policy changes, and I don't see someone with comparatively little government experience like Hahn being eager to start controversy in his first year,” March said.

“Measures to restrict [e-cigarette] access to minors should be handled at the state or even city level,” he continued. “There are ongoing investigations to whether vaping is linked to seizures and other health concerns in young adults the FDA is undertaking. Those are much more helpful in terms of influencing local policy than anything the FDA itself might do to regulate the vaping market.”

At last month's committee hearing, Hahn reiterated his commitment to let the data and science guide his decisions on vaping.

“Throughout my career, whether it was at a patient's bedside or as a medical executive, I've made decisions based upon data and science congruent with the law,” Hahn said. “Nothing is more important for a patient to trust you are making decisions on their best interest, no one else's.”

Sen. Doug Jones, D-Ala., argued during last month’s Senate committee hearing that the science is already available.

“I am really concerned that the [Trump] administration has prepped you on dodging and weaving a little bit in giving your answers,” he said.

Sharfstein said the next FDA commissioner should not simply bend to Trump’s demands.

"The FDA is a public health agency and should follow the science and evidence, not political directives,” he stressed.

The full Senate may vote on Hahn’s nomination by the end of the year, according to committee chair Sen. Lamar Alexander, R-Tenn. Until a confirmation vote occurs, Adm. Brett P. Giroir, MD, serves as acting FDA Commissioner. – by Janel Miller

Disclosures: Caplan, Freeman, March, Sharfstein and Siegel all report no relevant financial disclosures.

In an 18 to 5 vote earlier today, the Senate Health, Education, Labor and Pensions Committee sent the nomination of Stephen M. Hahn, MD, as the next FDA commissioner to the full Senate.

Hahn, chief medical executive and professor of radiation oncology at the University of Texas MD Anderson Cancer Center, had pledged during a hearing before the committee last month to be impartial on all FDA matters, such as the lung injuries tied to vaping, the opioid epidemic and the drug approval process.

“There are many issues that will come before the commissioner that are complex and engender honest disagreement,” Hahn said. “When that occurs, I pledge to listen, study and assess all viewpoints.”

However, after President Donald J. Trump backed off the idea of banning flavored e-cigarettes, some experts and lawmakers are concerned that Hahn will not commit to the ban if confirmed.

E-cigarette 
Lung injuries tied to vaping were one of several topics that Scott Hahn, MD, was asked about during a Senate committee hearing last month.
Source: Adobe

Healio Primary Care spoke with several experts about Hahn’s qualifications, his possible agenda and to what extent the president may influence FDA public health policy.

Hahn’s qualifications

If Hahn becomes the next FDA commissioner, it will be his first job in public service. Conversely, the previous five commissioners — Scott Gottlieb, MD; Robert M. Califf, MD; Margaret Hamburg, MD; Andrew C. von Eschenbach, MD; and Mark McClellan, MD, PhD — had some previous experience working in government agencies before becoming the FDA’s top official, according to their biographies on the FDA’s website.

Joshua M. Sharfstein, MD, a former deputy FDA commissioner under President Barack Obama, said in an interview that it is hard to find someone 100% qualified for the position.

“Nobody is entirely prepared to be FDA commissioner,” said Sharfstein, who is now a vice dean at Johns Hopkins Bloomberg School of Public Health. “It’s a very difficult job under the best of circumstances, and I certainly wish him the best.”

Michael B. Siegel, MD, professor at the Boston University School of Public Health, explained that government experience is not “absolutely necessary” for the job.

“Hahn understands the need to develop mechanisms to make cancer treatments available to patients as quickly as possible while still maintaining high standards for patient safety. If he applies this principle, he could make a major contribution to improve the availability of critical medications, while ensuring their safety.”

Robert Freeman, PhD, a former professor of pharmacy administration at the University of Maryland's Eastern Shore campus, pointed to Hahn’s “excellent research credentials, meaning he has significant managerial experience at the university level.”

“Commissioners set policy direction and leave the logistics of carrying out his/her directives to the career officers,” Freeman said in an interview. “As far as leadership is concerned, he's demonstrated the kinds of qualities you would want to see for this position.”

Others also saw Hahn’s background, which includes awards from, or memberships in, at least a dozen medical societies, and co-authorship of more than two dozen research papers, as a positive.

“Experience within the FDA would be valuable, but Hahn is a top-flight researcher, which means he has a lot of experience in dealing with FDA issues,” Arthur Caplan, PhD, founding head of medical ethics at the New York University School of Medicine. “His scientific and administrative pedigree counts for a lot in terms of qualifying experience.”

However, Raymond March, PhD, research fellow at the Independent Institute — a California-based think tank — and director of FDAReview.org, told Healio Primary Care it is “critical” that FDA commissioners have leadership experience at agencies with regulatory power. He is not convinced Hahn is the best fit for the job.

“Hahn is an established oncologist and strong cancer researcher but has little government experience and comparatively less research and leadership experience than others who were being considered,” March said. “That he was chosen over what I believe are more qualified candidates tells me cancer research is being put ahead of other considerations. I view this largely as a political move by the current administration.”

Hahn’s stance on vaping in question

Sen. Patty Murray, D-Wash., a member of the Senate committee who voted against Hahn’s nomination, also expressed concern about his lack of experience, but she said she was more concerned about Hahn’s stance on vaping.

“I’m not convinced Dr. Hahn is the right pick for the job,” she said today. “While I have been skeptical of his experience and public record on FDA policy issues or his experience leading an organization as complex as the FDA, I was particularly concerned that when pressed several times by members on both sides of the aisle, Dr Hahn refused to commit to implement a strong policy to clear nontobacco flavored e-cigarettes from the market,” Murray said.

PAGE BREAK

Even Sen. Mitt Romney, R-Utah, who voted in favor of Hahn’s nomination, said at today’s hearing that he had “some degree of concern” regarding Hahn’s position on vaping.

“I had hoped ... that he would place the interest of public health above any other interest, including political interest,” Romney said. “And that if for some reason he was directed to take action that was contrary to his view as a professional, and as a scientist and as a doctor, he would clearly state that he was directed to do so and would consider resignation.”

During last month’s committee hearing, Hahn pledged to work with Congress on several issues, including making more generic drugs available, lowering drug costs and coming up with solutions to end the opioid crisis.

But the recent spate of vaping-related lung injuries and children’s access to e-cigarettes took up most of the last month’s hearing. Sources agreed that Hahn needs to make combustible cigarettes and vaping one of his top priorities.

Sharfstein said the next commissioner “should implement the vision set out by Gottlieb, particularly around reducing nicotine levels in combustible cigarettes and regulating e-cigarettes to be less attractive to use.”

Siegel, who has researched various forms of cigarettes for more than 2 decades, hoped that Hahn will take a more balanced approach toward combustible and e-cigarettes.

“The Center for Tobacco Products has become obsessed over e-cigarettes to the point of being prepared to wipe out an entire industry, while having done literally nothing about cigarettes, the leading cause of preventable death in the United States,” he said. “Hahn’s first priority should be to recommit the agency to ending the smoking epidemic once and for all.”

March, who wants Hahn to focus on lowering prescription drug prices, expressed concern that little will change in terms of e-cigarette regulations.

“Few FDA commissioners have successfully navigated these controversial policy changes, and I don't see someone with comparatively little government experience like Hahn being eager to start controversy in his first year,” March said.

“Measures to restrict [e-cigarette] access to minors should be handled at the state or even city level,” he continued. “There are ongoing investigations to whether vaping is linked to seizures and other health concerns in young adults the FDA is undertaking. Those are much more helpful in terms of influencing local policy than anything the FDA itself might do to regulate the vaping market.”

At last month's committee hearing, Hahn reiterated his commitment to let the data and science guide his decisions on vaping.

“Throughout my career, whether it was at a patient's bedside or as a medical executive, I've made decisions based upon data and science congruent with the law,” Hahn said. “Nothing is more important for a patient to trust you are making decisions on their best interest, no one else's.”

Sen. Doug Jones, D-Ala., argued during last month’s Senate committee hearing that the science is already available.

“I am really concerned that the [Trump] administration has prepped you on dodging and weaving a little bit in giving your answers,” he said.

Sharfstein said the next FDA commissioner should not simply bend to Trump’s demands.

"The FDA is a public health agency and should follow the science and evidence, not political directives,” he stressed.

The full Senate may vote on Hahn’s nomination by the end of the year, according to committee chair Sen. Lamar Alexander, R-Tenn. Until a confirmation vote occurs, Adm. Brett P. Giroir, MD, serves as acting FDA Commissioner. – by Janel Miller

Disclosures: Caplan, Freeman, March, Sharfstein and Siegel all report no relevant financial disclosures.

    See more from Healio Special Report: Health Care and Politics