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November 21, 2019

Trump's FDA nominee faces questions on drug prices, e-cigarettes, and more

Daily Briefing

    Stephen Hahn, President Trump's nominee for FDA commissioner, on Wednesday faced questions from lawmakers on the Senate Health, Education, Labor and Pensions (HELP) Committee regarding drug shortages and prices, e-cigarette use, and more.


    Trump earlier this month announced that he would nominate, Hahn, CMO of MD Anderson Cancer Center in Houston, to serve as FDA commissioner. The post has not had a permanent leader since April, when former FDA Commissioner Scott Gottlieb left the position.

    Hahn, a radiation and medical oncologist, has served as MD Anderson Cancer Center's CMO since May 2018. Hahn previously served as the center's COO, and has been lauded for helping to restore the center's financial health. According to a White House release, Hahn also has served as a Gilbert H. Fletcher Memorial Distinguished Chair and professor of radiation oncology at MD Anderson since January 2015.

    Before moving to MD Anderson, Hahn from 1989 to 1996 worked at NCI as a senior investigator. He then took a position at the University of Pennsylvania, where he worked from 1996 to 2014. Hahn served as the university's chair of radiation oncology from 2005 to 2014.

    Throughout his career, Hahn has conducted various clinical trials, including studies involving proton therapy treatment for prostate cancer and combining radiation with immunotherapy. The White House release noted that Hahn "has authored 220 peer-reviewed original research articles." Hahn also holds five patents.

    However, Hahn also has been involved in some controversial situations throughout his career, STAT+ reports. For instance, while working at the University of Pennsylvania in 2009, Hahn appeared before the House Veterans' Affairs Committee "to deliver an in-person apology … after a doctor under his supervision implanted small radioactive 'seeds' used in some cancer treatments at the incorrect dose or in the incorrect organ in dozens of veterans," according to STAT+. In addition, Hahn "helped to extinguish concerns surrounding the recent dismissal of a small group of Chinese researchers" at MD Anderson, "assuring staff there the dismissals were driven by an ongoing federal investigation into foreign influence into research and were not racially driven," and has overseen care at MD Anderson as "[r]egulators this year … found [the center] had violated federal guidelines so severely that the regulatory failures 'substantially limit [the] hospital's capacity to render adequate care,'" STAT+ reports.

    Senators question Hahn

    The Senate HELP Committee on Wednesday held the first confirmation hearing on Hahn's nomination for FDA commissioner. During the hearing, senators questioned Hahn on issues regarding drug shortage and prices, rising e-cigarette use in the United States, and more.

    According to Inside Health Policy, growing e-cigarette use in the United States—particularly among youth—was the main issue senators focused on during the hearing. Both Democratic and Republican senators asked Hahn about his views on banning flavored e-cigarette sales in the United States—a proposal that Trump had touted earlier this year, but that has not yet advanced.

    Hahn did not provide details on actions he would take to address growing e-cigarette use, but said he supports "aggressive action to protect [U.S.] children." When asked whether he would try to implement a ban on flavored e-cigarettes, Hahn said he did not have "all the facts" on such a proposal, and therefore did not want to "prejudge" it.

    Senators also questioned Hahn on issues related to drug development, shortages, and prices.

    For instance, several senators said they believe FDA should encourage development of biosmilars and other generic drugs, and address so-called "patent gaming"—a practice that occurs when brand-name drugmakers block generic drugmakers' access to product samples needed to create generic drugs, or when brand-name drugmakers use loopholes to extend their patents for drugs.

    Hahn said he supports actions to increase transparency in the drug development process and quell anti-competitive practices. "I am very much in favor of transparency, and anti-competitive practices should be eliminated," he said.

    Hahn also addressed some senators' concerns about the safety of generic drugs, saying he would look to encourage adherence to manufacturing standards and improvements in manufacturing practices.

    In addition, Hahn said one of his priorities if he is confirmed as FDA's commissioner would be to address drug shortages in the United States. Hahn said he would look to increase competition in the market and work with Congress and federal regulators on other possible solutions. "This is an incredibly serious issue, and I look forward to working with Congress. I think there are things we can do to help," he said.

    Hahn also said he would look to address high prescription drug prices in the country by encouraging competition in the market. According to Modern Healthcare Hahn "did not commit" to supporting a policy to allow the United States to import drugs from other countries.

    Further, Hahn said he would look to advance the development of regenerative treatments, work with Congress to encourage innovation in mental health treatments, and support the development and approval of non-opioid pain treatments if he is confirmed as FDA commissioner.

    Senators also asked Hahn about his stance on cannabidiol (CBD) products. CBD is the second most abundant component of the cannabis plant after tetrahydrocannabinol (THC). Unlike THC, CBD does not get users high, but there is some limited evidence suggesting that it might have anti-anxiety, anticonvulsant, and anti-inflammatory effects.

    Hahn said he sees the potential for CBD products as treatments, but acknowledged that there still are a lot of questions and a lack of evidence on their effects. He said there is a need for transparent data on CBD and other hemp-based therapies so FDA can properly evaluate and make informed decisions about the products.

    Senators, former FDA commissioners praise Hahnbut Murray raises concerns

    Senate HELP Committee Chair Lamar Alexander (R-Tenn.) praised Hahn's background and said he intends to schedule a committee vote on Hahn's nomination for Dec. 3. Alexander said he hopes the full Senate will vote on Hahn's nomination by the end of this year.

    According to Inside Health Policy, a group of former FDA commissioners, including Gottlieb, in a letter sent Tuesday to senate leaders wrote that they support Hahn's nomination, noting his experience and commitment to public health and service.

    However, Sen. Patty Murray (D-Wash.), the ranking member on the Senate HELP Committee, during Wednesday's hearing raised concerns about Hahn's lack of experience in government. Murray also raised questions about whether Hahn would put science ahead of his political ideology and resist pressure from the Trump administration and lobbyists when necessary.

    Sen. Doug Jones (D-Ala.) during the hearing expressed disappointment regarding Hahn's responses to senators' questions about e-cigarette policies. He told Hahn, "I will tell you that I am less than happy with many of answers you gave on vaping and the potential ban on e-cigarettes" (Lienhard, Inside Health Policy, 11/20 [subscription required]; Facher, STAT+, 11/1 [subscription required]; Cohrs, Modern Healthcare, 11/20; McGinley, Washington Post, 11/20; Thomas, New York Times, 11/20; Wang, Inside Health Policy, 11/20 [subscription required]).

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