Vaping, Drug Issues Dominate FDA Chief Confirmation Hearing

Marcia Frellick

November 20, 2019

Stephen M. Hahn, MD, President Donald J. Trump's nominee to lead the United States Food and Drug Administration (FDA), fielded questions today on vaping flavorings, opioids, drug development and pricing, and a host of other topics during a US Senate committee confirmation hearing.

Hahn, a lung cancer specialist and chief medical executive at the University of Texas MD Anderson Cancer Center in Houston, answered questions by the 23-member Health, Education, Labor & Pensions committee.

Dr Stephen Hahn

Admiral Brett Giroir, MD, has been the acting FDA chief since earlier this month when he replaced National Cancer Institute Director Ned Sharpless, MD, who had been in the temporary role since Scott Gottlieb, MD, stepped down in April.

The issue that drew the most questions and passion was vaping and tobacco use among teens.

In September, the White House supported banning flavored e-cigarettes from the market. However, the administration, reportedly under pressure from vaping and tobacco lobbyists, is now reconsidering the ban. Bloomberg reports it is no longer on the Department of Health and Human Services agenda for the coming year.

While some senators praised Hahn's answers committing to studying the data and letting the science drive his decisions, should he be confirmed, one senator, Doug Jones (D-Ala.) said he was "less than happy" with the answers Hahn gave to multiple senators' questions regarding the topic.

"From where I sit, the data is in, the evidence is in, and it is really strong. You're a lung cancer doctor. You have been in this position before and I'm really concerned that the administration has prepped you in a way that is not you," Jones said.

While Jones did not ask for an immediate response from Hahn, he encouraged Hahn to review his answers as the confirmation process continues and to give "a more thoughtful" view on whether the flavorings should be banned immediately.

Sen. Mitt Romney (R-Utah) had asked, "We know that over 5 million high schoolers are addicted to nicotine through vaping products. The members of this body have been waiting for more than 2 months for the FDA to release a flavor ban. While we've been waiting, 35 more people have died from lung injury. Is the FDA under your leadership able and willing to take action which will protect our kids whether or not the White House wants you to take that action?"

Hahn responded, "Patients need to come first and the decisions that we make need to be guided by science and data congruent with the law."

Ranking member Sen. Patty Murray (D-Wash.) asked Hahn whether he would move forward with a ban on flavorings.

Hahn answered, "I am a lung cancer doctor and I have seen the ravages of tobacco-related cancers. It's all too real to me. I think this is an important, urgent crisis in the country. I do not want to see another generation of Americans become addicted to tobacco and nicotine and I believe we need to take aggressive action to stop that."

When Murray asked "Is that a yes or no?" that he would work to ban flavored e-cigarettes, Hahn answered, "I understand that the final compliance policy is under consideration by the administration and I look forward to their decision. I very much agree and support that aggressive action needs to be taken to protect our children."

"Have you told the president that you disagree with his decision to back away from those actions?" Murray asked.

"I have not had a conversation with the president," Hahn answered.

Opioid Use

Murray also asked what steps Hahn would take as leader of the FDA to address the opioid crisis.

He said he would support a holistic approach with increased approval of nonopioid products as well as looking into using medical devices to curb addictions.

"I believe, based on my experience at MD Anderson, that a comprehensive, holistic approach, often without opioids, can be very helpful in the treatment of pain, including cancer pain," he said. "This is a significant problem. What we have to do is balance the relief of suffering with making sure we prevent, as much as possible, misuse and addiction."

Drug Shortages

Sen. Susan Collins (R-Maine) addressed drug shortages, saying her state, in particular, is struggling.

"Maine Health, our largest healthcare organization is currently managing 40 such shortages," she said.

She asked if Hahn would commit publicly to working with the committee and explore other ways to mitigate the problem.

"I commit certainly to working with Congress on this issue," Hahn said. "There are things I think we can do to help."

Collins turned to drug prices and quoted Hahn's predecessor, Gottlieb, as saying, "If all the biosimilars that have been approved by the FDA were successfully marketed in this country in a timely fashion, Americans would have saved more than $4.5 billion in 2017."

She asked what role Hahn sees for the FDA in combination with the Federal Trade Commission and the patent office "to prevent the gaming of the patent system when we're dealing with biosimilars."

Hahn said, "Biologics represent an important treatment source for cancer patients and the upward pressure they're causing on prices is substantial. The biosimilar pathway is crucial and I'm very much in favor of transparency and that anticompetitive practices should be eliminated."

Decision Likely Next Month

Committee Chairman Lamar Alexander (R-Tenn.) has already announced his support for Hahn and he said today that he believes the committee will follow suit. Alexander said he hopes for a markup of the proposed confirmation by December 3 and confirmation of Hahn's nomination by the full Senate by the end of December.

Five former FDA commissioners in a letter shared with Politico on Tuesday called on Senate leadership to quickly confirm Hahn.

Politico quoted the letter as saying, "We believe Dr Hahn has the experience and commitment to public health and public service needed," noting it was signed by former FDA commissioners Mark McClellan, MD, Andrew von Eschenbach, MD, Margaret Hamburg, MD, Robert Califf, MD, and Scott Gottlieb, MD.

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