How much Senate Democrats oppose President Donald Trump's new nominee to take over the reins of the FDA could depend on whom they dislike or distrust more Stephen Hahn, the nominee, or Brett Giroir, who just became the new acting FDA commissioner.
"I'm alarmed that Dr. Giroir will step in as acting commissioner given his track record of letting ideology drive decisions at the expense of women and families," Sen. Patty Murray (D-Wash.) said Friday after Health and Human Services (HHS) Secretary Alex Azar announced that Giroir would be taking on the FDA duties while Hahn goes through the confirmation process.
Murray is the ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, which will be responsible for holding Hahn's confirmation hearing and voting on whether to pass his nomination on to the full Senate for a vote.
Murray has been a vocal critic of Giroir since he was first nominated in May 2017 as assistant secretary of health with oversight of the Public Health Services and HHS' Office of Population Affairs. The senator's opposition centered on her concerns that Giroir would not be supportive of women's health issues and funding for Planned Parenthood.
Both then and now, groups such as the National Women's Health Network (NWHN) echoed Murray's concerns about the Texas pediatrician. In 2017, NWHN petitioned the administration to reconsider Giroir's nomination to the HHS post.
Because the opposition delayed Giroir's confirmation, Trump had to renominate him to the post again in January 2018 before he was finally confirmed.
Now, the NWHN is saying it's "gravely concerned" about Giroir serving in a temporary capacity as the head of the FDA, citing his oversight of "massive cuts to HHS' Office of Population Affairs, which administers the Title X program for family planning and reproductive health funding, and anti-abortion attacks on medical research."
"We do not want to see the FDA entangled in the politics around reproductive health and women's health," the group said. "And make no mistake, under Giroir's leadership women's reproductive health is at stake."
Giroir is taking over the temporary mantle from Ned Sharpless, who stepped down last week as acting commissioner to return to his former position as director of the National Cancer Institute (NCI). Azar explained the change, saying the Federal Vacancies Reform Act limits service in an "acting" capacity to 210 days. Sharpless' 210 days ended Friday.
Whether Giroir will helm the FDA for a full 210 days, which would continue into late May, will depend on how quickly the Senate acts on Hahn's confirmation. The administration hopes the confirmation process will be expeditious, Azar said.
Having a confirmed commissioner in place would help the administration advance its agenda at the FDA. The administration has been pushing initiatives in a lot of different areas the agency oversees, including drug prices, Chad Landmon, chair of the intellectual property and FDA practice groups at Axinn, Veltrop & Harkrider LLP, told BioWorld, adding that it's difficult for an acting commissioner to forcefully advance those priorities.
"They can keep the status quo moving," Landmon said of an acting commissioner. That reality was evident under Sharpless' tenure at the FDA as tackling vaping and youth tobacco use became a top priority for Congress. Despite his temporary capacity, Sharpless was criticized for not doing enough about the tobacco problem.
"The crisis of skyrocketing youth tobacco use, which has been fueled by FDA's unwillingness to take meaningful action . . . continues to be a serious concern of mine," Murray said Friday.
On the House side, Rep. Frank Pallone (D-N.J.) made similar remarks in a letter last week to Trump. He noted that the president's promise in September to remove flavored e-cigarettes from the market has gone unfulfilled.
Given congressional pressure to do something about vaping, it's sure to be a question Hahn will face as he meets with senators as Trump's FDA nominee. And with the next presidential election only a year away, the vetting process is bound to be political, especially since Hahn was a bit of a surprise when his name was first floated for the position.
A radiation oncologist specializing in lung cancer and sarcoma and the chief medical executive at the University of Texas MD Anderson Cancer Center in Houston, Hahn is "a little bit outside of the box" as a candidate for the FDA's top spot, Landmon said. With little agency or industry experience, "he's more of an unknown" for a lot of people, Landmon added.
While Hahn may not be well known in industry and government circles, he has made a name for himself in the medical field. After receiving his medical degree from Temple University in 1984, Hahn completed a residency in radiation oncology and a fellowship in medical oncology at NCI and then became a senior investigator there from 1989-1996. He served as an oncology professor and chaired the radiation oncology department at the University of Pennsylvania before going to MD Anderson in 2015. Over the years, he's authored 220 peer-reviewed research articles.
Because of Hahn's low profile outside his field, some organizations and even Republican senators seem to be taking a wait-and-see attitude toward his nomination, Landmon said, perhaps because they don't want to do anything to mess up the confirmation.
For instance, Sen. Lamar Alexander (R-Tenn.), chair of the HELP Committee, was noncommittal in his reaction to Trump's announcement Friday: "Having the right person lead the FDA is critical to virtually every American. . . . I look forward to meeting with Dr. Hahn and scheduling a hearing to consider his nomination."
The Biotechnology Innovation Organization (BIO) also was cautious in its response, as it noted the critical role the FDA plays in ensuring access to medical and food-related biotechnology innovations. "We intend to follow the confirmation process closely and hope Dr. Hahn will demonstrate a firm understanding of the power and promise of biotechnology and the role of FDA in facilitating it," BIO spokesperson Andrew Segerman told BioWorld.
Stephen Ubl, CEO of Pharmaceutical Research and Manufacturers of America, showed more optimism as he congratulated Hahn on the nomination. "We look forward to working with Dr. Hahn in his new role, engaging the agency towards increasing regulatory predictability, decreasing regulatory burden and embracing the digital transformation of the biopharmaceutical industry," Ubl said.
Advamed was even more positive in its response, saying it hoped the Senate moves swiftly to confirm Hahn. "Dr. Hahn's distinguished career as a health care provider and researcher gives him a unique perspective on the importance of patient access to the latest medical advances," Advamed President and CEO Scott Whitaker said. "His extensive management experience and evidence-based approach to addressing the significant health care challenges we face today will serve him well in his new post."
But there's still the question of how politics will play out in his nomination. "I'll be vetting Dr. Hahn thoroughly to determine whether he is qualified for this position and committed to serving families, prioritizing science and upholding the Food and Drug Administration's gold standard for product safety and effectiveness," Murray said. "Families across the country who count on the FDA to keep them safe should be able to trust it is being run capably and without interference from partisanship or ideology."