On September 24, U.S. Food and Drug Administration (FDA) Commissioner nominee Heidi Overton reportedly “sidestepped” key questions from senators about mifepristone, vaccines, and fruit-flavored electronic nicotine delivery devices (ENDS). In numerous situations, Overton reiterated FDA’s existing positions or her responsibility to follow the law rather than giving her own views or acknowledging that President Donald Trump was wrong in recent statements about those topics.
As noted in a previous blog, a number of senators who will play key roles in Overton’s confirmation, including outgoing Republican Sen. Bill Cassidy of Louisiana – a physician and chair of the Senate Health, Education, Labor, and Pensions Committee – and other Make America Healthy Again supporters, have expressed doubts about Overton. Expected topics for her confirmation hearing included mifepristone and her views on abortion, vaccines, food supply safety, the rapid growth of peptide compounding, the use of pesticides such as glyphosate, and staffing issues at FDA.
Some questions centered on Overton’s prior role as chief policy officer at the conservative think tank America First Policy Institute, her current role as a domestic policy official in the White House, and her background as a preventive medicine physician. Committee members tried to have her commit to positions on issues facing FDA, especially where FDA’s prior positions clashed with the Trump administration.
Examples of these exchanges included the following:
- Regarding mifepristone, Democratic Sen. Patty Murray of Washington asked, “Do you agree with the FDA’s approval of mifepristone, which means the agency deems it safe and effective?”
- Overton responded, “Mifepristone was approved by the FDA as having met its safety and efficacy standard,” but declined to answer direct questions about whether she personally believes mifepristone is safe, even though she previously described the drug as “dangerous to women.” Moreover, in her prior role at America First Policy Institute, she praised the U.S. Supreme Court’s decision to overturn Roe v. Wade and called for strict restrictions on abortion medication.
- When asked about the measles, mumps, and rubella vaccine and the Trump administration’s suggestion to administer the vaccines separately rather than combine them into one injection, Overton called it “safe and effective” and the country’s “best tool” for responding to measles.
- When senators pressed Overton on Trump’s claim that the vaccine was “lethal,” she repeatedly declined to say whether the president was wrong. Overton had appeared alongside Trump during the public announcement at which he made those statements and was nominated days later.
- Democratic Sen. Chris Murphy of Connecticut said, “You’ve done a good job at avoiding questions,” in response to Overton’s answers to questions about fruit-flavored e-cigarettes and FDA’s scaled-back use of advisory committees.
- Senators asked Overton whether Trump’s meetings with tobacco industry representatives and his financial ties to the industry, which coincided with former FDA Commissioner Marty Makary’s resignation, raised concerns and whether the Trump administration planned to expedite authorization of additional ENDS products. Overton, however, said that despite being a domestic policy official in the Trump administration, she was not aware of such plans and did not seem prepared to answer questions about the review process for ENDS products. Instead, she said there was evidence that flavored ENDS products could help some adults quit smoking.
- A number of senators asked Overton whether she would ever disagree with Trump or tell him he was wrong.
- Overton did not answer the question directly but said, “It is the president who sets the policy directions, but he works with all of his advisers to get the best information. My experience has been, he wants to make the best decision in the best interest of Americans.” Democratic Sen. Maggie Hassan of New Hampshire was disappointed with this response and said, “The American people need a leader at the FDA who is able to say that the president is wrong when he is.”
Key Takeaways
I listened to the confirmation hearing and offer the following observations. First, several senators expressed concern that Overton would not challenge anyone in the Trump administration if administration officials asked her, as FDA commissioner, to take an action she knew or had reason to believe was improper. Several senators suggested that Overton was deliberately avoiding questions and claimed not to know information that they believed should have been available to her in her present role in the White House. While there was some discussion of the challenges Overton would face rebuilding FDA’s senior staff following departures early in the second Trump administration, senators devoted less attention to her largely untested managerial experience, particularly given the size of FDA. Finally, when asked specific questions about FDA – including its staffing levels and how the premarket tobacco product application process affects the distribution of ENDS products – Overton appeared less prepared.
We will continue to monitor Overton’s confirmation proceedings.
This blog was drafted by Brian Malkin, co-lead of the Spencer Fane FDA Pharmaceutical and Biologics Market Team. For more information, visit spencerfane.com.
