Stephen Hahn Nominated for FDA Commissioner

The ongoing saga over the occupant of FDA commissioner’s office has taken another turn, although one that has been discussed in the media for some time. Stephen Hahn, chief medical director of the MD Anderson Cancer Center in Houston, has been named the Trump administration’s nominee for the job, continuing the trend of physicians who hold the position either permanently or as an interim commissioner.

Hahn’s name has populated the rumor mill since at least September, and he is the fourth consecutive physician to be nominated as the full-time FDA commissioner. He would also be the second consecutive oncologist to sit in the commissioner’s chair after Ned Sharpless, who will return to his previous position as director of the National Cancer Institute.

Prior to Sharpless, Scott Gottlieb, Robert Califf, Peggy Hamburg and Andrew von Eschenbach were each MDs who served as commissioners for more or less brief terms. Von Eschenbach and Sharpless have both served as director of the NCI, although Gottlieb and Hamburg were primarily known for policy and administrative work, respectively, prior to taking the FDA commissioner’s post.

Califf, a cardiologist who served in an administrative capacity at the Duke Clinical Research Institute, took over at the FDA in the last year of the Obama administration. Califf had already been employed at the agency prior to his appointment, however, a distinction that does not apply to Hahn. Nonetheless, Hahn may also find himself in a short-term situation as President Trump faces a number of political headwinds that could affect his chances for reelection. Should a new president be sworn into office in January 2021, the FDA could find itself in need of yet another new commissioner.

HHS’s Giroir the Acting Commissioner

As the Senate prepares to vet Hahn, Assistant Secretary for Health Brett Giroir will direct operations at the FDA, a move that may be favored by those attempting to grapple with the opioid crisis. Giroir has spearheaded the opioid response at HHS, although the nomination of Hahn may be construed as affirming the federal government’s emphasis on finding cures for cancer. HHS said in a Nov. 1 statement that Sharpless was required to step down due to the 210-day limit for acting federal agency directors imposed by the statute.

Just as Califf was grilled over his relations with drugmakers, Hahn is likely to face a number of difficult questions, although some of those may center around the dismissal of several Chinese researchers at Anderson. The NIH emphasis on thwarting medical science espionage led to the dismissal of three researchers from China earlier this year, a move that was decried in some quarters as an example of xenophobia.

Another issue that will confront Hahn in confirmation hearings is the drug pricing controversy, something Gottlieb approached carefully and with an emphasis on generic drug reviews. Hahn is certain to be pressed to address both the opioid crisis and the running controversy over efforts by drugmakers and biotech companies to delay competition from generics.

Perhaps the most immediate pressure will come from the waning availability of medical devices as a result of the closure of sterilization facilities that use ethylene oxide, although this problem has yet to capture any meaningful attention on Capitol Hill. The FDA’s precertification program for software as a medical device is also certain to feed some of the questions Hahn will face at Senate hearings, particularly given the recent letter from three members of the Senate regarding the program.

The Oct. 30 letter to Sharpless poses several questions about the precert pilot program, with much of the emphasis on the legality of the precert program. For example, the letter asks whether the FDA believes Congress had authorized the de novo program to allow the FDA to “establish pilot programs that fundamentally alter the FDA’s existing method of device review and approval.” Perhaps the most salient aspect of this letter for Hahn’s purposes is that the authors of the letter, Sens. Patty Murray, Elizabeth Warren, and Tina Smith, are all members of the Senate committee that will vet Hahn for the job, the Senate Health, Education, Labor and Pensions Committee.