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Key Vote in FDA Commissioner Confirmation Process Set for December 3rd

The Senate Health, Education, Labor and Pensions (HELP) Committee is set to vote on Dr. Stephen Hahn, the Trump administration’s nominee to head the Food and Drug Administration (FDA), on December 3, 2019. Dr. Hahn faced a flurry of questions at the confirmation hearing before the HELP Committee on Wednesday, November 20, 2019, most of which spoke to the youth vaping crisis with minimal emphasis on other hot topics, such as prescription drug shortages or drug pricing. Despite the barrage of questions from senators, however, many of the nominee’s responses were non-specific in nature and avoided committing to any set platform. Instead, Dr. Hahn focused his remarks on his physician’s pledge to put patient care first and rely on science, data, and the law as a basis for decision-making. Read his prepared testimony here.

Vaping took center stage during the confirmation hearing as many committee members voiced concern over President Trump’s recent comments backtracking his plan to ban all flavored e-cigarettes except tobacco. Dr. Hahn acknowledged that “aggressive action” is necessary to prevent another generation from falling victim to nicotine addiction; however, he stopped short of committing to an actual ban or putting forth specific policy ideas.

Equally as notable was the lack of questions or answers during the November 20th confirmation hearing geared towards FDA’s role in a number of high-priority areas, such as in facilitating lower drug costs, generic drug and biosimilar approvals, or recent proposals for solving prescription drug shortages. Instead, Dr. Hahn repeatedly affirmed that he is "open to all science and data that could potentially support” a wide range of agency challenges including the use of drug importation as a solution to the drug pricing problem. Similarly, he provided a noncommittal response to address drug shortages, stating only that “there are things that we can do to help.”

FDA is in desperate need of a permanent FDA commissioner since Dr. Scott Gottlieb left the job in April 2019. Dr. Hahn is currently the chief medical executive of MD Anderson Cancer Center and has no political experience and apparently few existing policy preferences with respect to the agency’s broad public health mission. Nonetheless, according to the Washington Post, Dr. Hahn has the endorsement of five previous FDA commissioners, including Dr. Gottlieb; the Obama administration’s Robert Califf and Margaret Hamburg; and the George W. Bush administration’s Mark McClellan and Andrew von Eschenbach. If his nomination is advanced by the Senate HELP Committee following the panel’s vote on December 3rd, it will then be sent to the full Senate for a final confirmation vote. The Committee’s leadership has made clear that it intends to have Dr. Hahn confirmed by the end of the year – a goal that is likely shared by all FDA stakeholders as the agency continues to tread water without a permanent commissioner in place to take ownership of all its critical programs or to advance new initiatives.

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Author

Elizabeth Conti is a Mintz attorney who focuses her practice on regulatory compliance and enforcement defense matters for health care, life sciences, and consumer product companies.