Executive Summary

Bipartisan Senate confirmation vote comes despite concerns about Stephen Hahn’s non-answers to e-cigarette regulation questions.

Stephen Hahn cruised to confirmation as the next US Food and Drug Administration commissioner 12 December, but not without another warning that his yet-to-be articulated stance on vaping will be closely scrutinized.

Hahn was confirmed by the Senate 72-18 after 37 days, the shortest of time from nomination to confirmation since Mark McClellan needed less than a month in 2002. (See chart below.)

Sen. Patty Murray, D-WA, ranking member of the Health, Education, Labor and Pensions Committee, said prior to a 11 December vote to end debate on the nomination that because of Hahn’s evasive responses to questions about curbing youth e-cigarette use, she would oppose confirmation. She also said that she was not convinced Hahn would uphold FDA standards.

Murray made similar statements during the committee’s consideration of Hahn’s nomination. Amid repeated questions about a proposed ban of non-tobacco e-cigarette flavors and plans to curb youth use of the products, Hahn said that he did not want to prejudge the White House policy that remains under consideration, but would use science and data to guide his decision. (Also see “Hahn Confirmation Hearing: Solid Performance Light On Substance” – Pink Sheet, 20 Nov, 2019.)

HELP Committee Chairman Lamar Alexander, R-TN, highlighted Hahn’s qualifications prior to the cloture vote, saying the federal government should be grateful he is willing to serve. He also reminded Senators that Hahn has been endorsed by more than 80 organizations, as well as five former FDA commissioners.

“All around, he is exactly the type of nominee we want to lead an agency as important as the FDA,” Alexander said in a written statement following the confirmation vote.

American Association for Cancer Research President Elaine Mardis also said in a statement that Hahn’s qualifications are impressive, “including his background as a highly regarded physician and extremely effective scientific administrator.”

“Hahn understands the challenges that patients face every day, and also knows firsthand the importance of utilizing scientific-based evidence to evaluate the safety and efficacy of new therapies and devices,” Mardis said.

Friends of Cancer Research Chair and Founder Ellen Sigal praised Hahn’s confirmation as positive for patients.

“The U.S. is at an inflection point for science and innovation,” she said. “Hahn has a strong focus on advancing and improving the public health. His experience has prepared him to bolster the FDA’s important work that directly impacts patients’ lives.”

An oncologist and chief medical executive at MD Anderson Cancer Center, Hahn will replace Adm. Brett Giroir, the Health and Human Services Department assistant secretary for health who had been serving as acting commissioner since Hahn was nominated for the permanent position. (Also see “Giroir Becomes Acting US FDA Commissioner, Giving Agency Experienced Political Hand” – Pink Sheet, 1 Nov, 2019.)

Senate Returns To Voting Tradition

Hahn’s confirmation vote also represents a shift back to a traditional Senate pattern for FDA leadership changes.

Historically, commissioners received overwhelming majorities in favor of confirmation. McClellan, Margaret Hamburg and Jane Henney were confirmed by voice vote and David Kessler was confirmed by unanimous consent. Others received at least 78 votes in favor. (See chart.)

The one exception was Scott Gottlieb, who was confirmed with a largely partisan Senate vote at the beginning of the Trump administration. (Also see “Gottlieb Becomes US FDA Commissioner With Immediate Issues Pending” – Pink Sheet, 9 May, 2017.)

Hahn did not seem to undergo the same level of Senate scrutiny during the public confirmation process as Gottlieb, particularly related to potential conflicts of interest. (Also see “Drug Development Questions Dominate Hahn’s Confirmation, Despite Talk About E-Cigs” – Pink Sheet, 20 Nov, 2019.) Interestingly, one reason for the move may be because his term will begin with a presidential election less than a year away. (Also see “Hahn Confirmation Hearing: Pharma May Be Left Parsing Non-Rx Questions For Policy Clues ” – Pink Sheet, 18 Nov, 2019.)

Sharpless Says Running FDA Was Not A Vacation

Indeed, while Hahn cannot predict the length of his term, he likely can expect it will not be smooth.

Norman Sharpless, who was appointed acting FDA commissioner following Gottlieb’s departure in April, jokingly described his seven months at the agency as “the worst vacation of my life.”

Sharpless was director of the National Cancer Institute prior to becoming acting FDA commissioner and returned to NCI when Giroir was named the new acting commissioner.

Sharpless made the comments during a 3 December speech to the NCI Board of Scientific Advisors and National Cancer Advisory Board. He also observed that FDA decisions often are extremely complex and must be made with the data that is available, which may serve as a warning for Hahn that running the FDA will not be easy.

In addition to e-cigarettes, Hahn must continue FDA efforts to fight the opioid epidemic, which includes writing new prescribing guidelines (Also see “US FDA Wants Opioid Prescribing Guidelines To Be Highly Specific, But It May Have To Compromise” – Pink Sheet, 7 Feb, 2019.), and increasing naloxone access. (Also see “US FDA’s Words Matter: Sharpless Says Injectable Naloxone OK For Community Distribution” – Pink Sheet, 25 Sep, 2019.) He also will be expected to take up the agency’s role in the federal government’s campaign to lower drug prices, which includes increasing generic competition. (Also see “ANDA Approval Records Will End As US FDA Mops Up Backlog” – Pink Sheet, 4 Dec, 2019.)

Negotiations to reauthorize the prescription drug, generic drug and biosimilar user fee programs also are set to begin in 2020 in advance of their 2022 expiration. Hahn likely will not be a direct participant, but given the importance of the programs to agency budgets and policy, they likely will require his attention.

And in between, Hahn will set his own priorities and determine how he can leave his mark on the FDA.

Hahn has not served in the federal government since his early career, Most of his time as an oncologist has been spent in academic medicine. (Also see “Stephen Hahn For US FDA Commissioner: Will Academic Experience Suffice For Confirmation?” – Pink Sheet, 1 Nov, 2019.)

https://pink.pharmaintelligence.informa.com/PS141356/New-US-FDA-Commiss…