FDA/CDC

Vaping front and center at Hahn’s first FDA confirmation hearing


 

REPORTING FROM A SENATE SUBCOMMITTEE HEARING

Stephen Hahn, MD, President Trump’s pick to head the Food and Drug Administration, faced questions from both sides of the aisle on youth vaping, but came up short when asked to commit to taking action, particularly on banning flavored vaping products.

Dr. Stephen Hahn of The University of Texas MD Anderson Cancer Center.

Dr. Stephen Hahn

Speaking at a Nov. 20 confirmation hearing before the Senate Health, Education, Labor, and Pensions Committee, Dr. Hahn said that youth vaping and e-cigarette use is “an important, urgent crisis in this country. I do not want to see another generation of Americans become addicted to tobacco and nicotine and I believe that we need to take aggressive to stop that.”

Sen. Patty Murray (D-Wash), the committee’s ranking member, asked Dr. Hahn whether he would work to finalize a ban flavored e-cigarette products, first proposed but then backed away from, by the president in September.

“I understand that the final compliance policy is under consideration by the administration, and I look forward to their decision,” Dr. Hahn said. “I am not privy to those decision-making processes, but I very much agree and support that aggressive action needs to be taken to protect our children.”

When pressed by Sen. Murray as to whether he told President Trump that he disagrees with the decision to back away the proposed ban, Dr. Hahn revealed that he has “not had a conversation with the president.”

Dr. Hahn, a radiation oncologist who currently serves as chief medical executive at MD Anderson Cancer Center, Houston, held firm to just coming up short of making that commitment when questioned by senators from both parties.

Sen. Mitt Romney (R-Utah) warned Dr. Hahn that the playing of politics would be unlike anything he has seen and is already being played out in the lobbying of the administration to change its stance on flavored e-cigarette products, which can run counter to the science about the harmful effects of these products.

“The question is how you will balance those things in which you put forward,” Sen. Romney asked. “How you will deal with this issue is a pretty good test case for how you would deal with this issue on an ongoing basis on matters not just related to vaping.”

He also brought up President Trump’s September announcement on a flavor ban and the administration’s signaling they are moving away from a flavor ban. “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?”

Dr. Hahn cited his pledge as a doctor to always put the patient first and reiterated that “I take that pledge very seriously and I think if you ask anyone who has worked with me, they will tell you that I have upheld that pledge.”

But he fell short of saying that he would take actions that would oppose the White House, saying only that “patients need to come first and the decisions that we make need to be guided by science and data, congruent with the law.”

When asked by Sen. Romney if he saw any reason for holding off on a flavor ban, given the evidence that suggests flavored e-cigarette products are the gateway to youths nicotine addiction, Dr. Hahn said that he has seen the same evidence and that it requires “bold action,” but did not commit to a flavor ban. “I will use science and data to guide the decisions if I am fortunate enough to be confirmed, and I won’t back away from that.”

Sen. Doug Jones (D-Ala.) expressed concern about Dr. Hahn’s answers.

“I was less than happy with many of the answers you gave to members of this committee with regard to vaping and the potential ban on flavored e-cigarettes,” Sen. Jones said. “I think you can tell from the questions of so many senators that is one of the biggest issues that the United States Senate and Congress is facing right now. It is with this committee.”

Outside of vaping, much of the senators’ questioning was nonconfrontational, with questions spanning a gamut of issues facing the FDA.

Dr. Hahn offered his commitment to working with Congress to address drug shortages, noting nonspecifically that, “there are things that we can do to help.”

He also pledged to work with Congress on addressing patent reform to get more biosimilars to market in an effort to help drive down drug prices.

Regarding opioids, Dr. Hahn was asked about balancing the needs of those who legitimately need access to opioids against abuse and diversion.

“When I first went to medical school and started taking care of cancer patients, the teaching was that cancer patients should be treated liberally with opioids and that they don’t become addicted to pain medications,” he said. “We found out that wasn’t the case – and in some instances – with tragic consequences.”

He noted that pain therapy has evolved and that his institution now takes a multidisciplinary approach employing both opioid and nonopioid medications.

“I am very much a supporter of the multidisciplinary approach to treating pain,” he said. “I think it is something that we need to more of and if I am fortunate enough to be confirmed as commissioner of [FDA], I look forward to furthering the education efforts for providers and patients.”

Other areas he committed to included helping to improve clinical trial design for psychiatric medications and improving development of therapies for rare diseases.

Committee Chairman Lamar Alexander (R-Tenn.) said he plans to schedule a Dec. 3 vote to advance Dr. Hahn’s nomination to the full Senate for its consideration.

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