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# Overton Pledges Science-Based FDA Decisions at Confirmation Hearing
- URL: https://www.fdaweb.com/overton-pledges-science-based-fda-decisions-at-confirmation-hearing-d5161836/
- Published: 2026-09-24T13:00:00.000Z
- Updated: 2026-09-25T19:21:35.000Z
- Author: David McFarland
- Tags: FDA Policy/General, Legacy-ID-D5161836, #Import 2026-09-24 19:50

FDA commissioner nominee **Heidi Overton** pledged to accelerate drug development, strengthen regulatory oversight and preserve the agency's scientific independence during her Senate confirmation hearing Thursday, while facing pointed questions from lawmakers about vaccine safety, medication abortion, tobacco regulation and political interference in FDA decisions.

Overton, a White House domestic policy adviser, told the Senate Health, Education, Labor and Pensions Committee that President Trump had directed her to bring a "go fast" approach to FDA, with an emphasis on reducing regulatory barriers that she said are driving biotechnology investment and clinical trials overseas.

"If confirmed as commissioner of food and drugs, I will immediately set my focus to restoring the primacy of American innovation while furthering the core missions of advancing national security, increasing access to affordable treatments and promoting public health," Overton said. She identified competition from China as a central concern, warning that the U.S. risks losing its leadership in biotechnology unless FDA modernizes its approach to clinical trials and drug development.

Overton pointed to FDA's Operation Trialblazer initiative and pledged to work with career agency staff to streamline clinical trials and make innovative therapies available to patients more quickly. She also expressed support for greater regulatory flexibility in rare disease drug development, including small clinical trials and individualized treatment approaches. Responding to questions about rare diseases for which large randomized trials may be impractical, Overton said FDA should consider expanding its approach beyond single-patient studies to trials involving five or 20 patients.

She said risk-based review policies and greater consistency among FDA reviewers should be formalized to reduce what Committee chairman **Bill Cassidy** (R-LA) described as a regulatory review lottery. "I believe there's a lot we can do right now to help these patients," Overton said.

Cassidy opened the hearing by warning that political interference and misinformation have damaged public confidence in FDA and HHS. He questioned whether Overton would challenge the president if administration directives conflicted with scientific evidence or commitments she made to Congress.

Cassidy specifically challenged Trump's characterization of the measles, mumps and rubella vaccine as potentially lethal. Overton tread carefully as to not agree that Trump was wrong, responding that the MMR vaccine is safe and effective and describing it as the country's primary tool for combating measles outbreaks. She also said that all vaccines currently on the U.S. market have met FDA's safety and efficacy standards.

Asked what role Administration officials should play in individual FDA product approval decisions, Overton said those determinations must remain within the agency. "Individual product reviews and determination should be made according to statute, under the purview of the FDA," she said, adding that FDA should rely on recommendations from career scientific reviewers.

Cassidy pressed her on whether she would honor commitments made to Congress if Trump subsequently directed her to take a different course. Again, Overton tactfully responded, saying she would provide the president with her best advice and follow the statutory requirements governing FDA product determinations.

Sen. **Maggie Hassan** (D-NH) also questioned whether Overton would follow the law if the president directed her to take an unlawful action. "I will follow the law if I'm confirmed as FDA commissioner," Overton responded. However, she declined to directly characterize Trump's previous statements about vaccine safety as incorrect, despite repeatedly affirming that the MMR vaccine is safe and effective. She also said she had not seen evidence establishing a causal relationship between acetaminophen use and autism, but did not directly criticize the president's previous statements discouraging pregnant women from taking the medication.

Overton faced questions from senators on both sides of the aisle about FDA's ongoing safety review of mifepristone and the potential for changes to its risk evaluation and mitigation strategy (REMS). Asked whether she personally believes mifepristone is safe and effective, Overton repeatedly referred to the agency's existing regulatory determination. "According to FDA standards, the drug is safe and effective as labeled today, with the appropriate risk evaluation mitigation strategy," she told Sen. **Tammy Baldwin** (D-WI). Overton declined to prejudge whether the drug's labeling or REMS should be changed, citing the ongoing FDA safety review.

Sen. **Chris Murphy** (D-CT) questioned whether political interference had influenced recent FDA tobacco decisions and pressed Overton to commit to restoring the agency's advisory committee system. Overton said advisory committees would remain an important part of FDA's regulatory process. "My goal would be to not shut down any advisory committees," she said, while adding that she would review their operations to ensure they were fulfilling their intended purposes.