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FDA nominee says he will follow REMS data and review mifepristone policy if confirmed
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Summary
Dr. Marty Makary told senators he will follow the Food and Drug Administration's independent scientific review process and examine ongoing REMS data for mifepristone; several senators pressed for explicit commitments to maintain access and to avoid political interference.
Dr. Marty Makary told the Senate HELP Committee that, if confirmed as FDA commissioner, he would follow the agency’s independent scientific review process and examine the ongoing data collected under the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone.
"I have no preconceived plans to make changes to the mifepristone policy," Dr. Makary said, adding that he would "follow the law and the regulation of the REMS to look at ongoing data." He told senators he would meet with career scientists at the agency and review the totality of evidence before making any policy changes.
Senators including Patty Murray and Susan Collins pressed Dr. Makary for a clearer pledge to preserve current access to the drug. Senator Murray noted the body of published studies she and other senators cited and asked whether the nominee would uphold evidence-based approvals for FDA-regulated products, including contraception and medication abortion. Senator Murray said the literature includes more than 100 studies supporting safety and efficacy.
Dr. Makary said he was "very familiar with mifepristone" and that he had read studies provided to him prior to the hearing, but repeated that he had not yet reviewed the totality of the agency’s REMS data. He emphasized that ongoing surveillance data could reveal unanticipated drug–drug interactions or safety signals that merit further review.
Other senators expressed concern about the removal in recent years of in-person dispensing and some reporting requirements for the drug, and asked whether Dr. Makary would restore prior reporting or in-person dispensing rules. The nominee declined to pre-commit to reinstating specific prior requirements, saying instead he would review the evidence and follow statutory and regulatory obligations.
The exchange underscored senators’ interest in preserving the FDA’s scientific independence and their concern that political pressure not override the agency’s scientific determinations.
