FDA commissioner nominee Heidi Overton walked a fine line Thursday responding to senators’ questions about how she’d regulate medication abortion if confirmed, irritating Republicans and Democrats alike and complicating her path to confirmation. “According to FDA standards, the drug is safe and effective as labeled today,” Overton told Sen. Tammy Baldwin (D-Wis.), referring to mifepristone, during a Senate Health, Education, Labor and Pensions Committee hearing. When Baldwin asked if the label for the drug, which is used in more than two-thirds of abortions, should be changed, Overton demurred. “I can’t prejudge the determination of the safety review that's currently ongoing,” Overton, an abortion opponent who serves as a White House domestic policy adviser on health care, said. If confirmed, Overton would lead the Food and Drug Administration as it undertakes a controversial study of mifepristone’s safety that abortion opponents have long demanded. Missouri Republican Josh Hawley, who staunchly opposes abortion, argued during the hearing that Overton’s position on mifepristone clashes with the position the Trump administration has asserted in court battles over federal regulation of the medication. He claimed that because the FDA is not defending on the merits of Biden administration changes to the drug’s oversight that allowed it to be prescribed via telehealth without an in-person evaluation and is instead sticking to procedural arguments about challengers’ lack of standing, that conflicts with Overton’s assertion that the agency believes the drugs are safe and effective as currently labeled. “Right now, there has not been a change to the label,” Overton said. “That safety study is ongoing and very important. Women’s health and women’s safety is a critical piece of this, so there is no change in position.” Hawley said outside the hearing room that he may not support Overton's nomination unless she clarifies her comments on the FDA's position regarding mifepristone's label. "If what she said today is their new position, that would be a complete change in their litigating position, and that would have very dire consequences," he told reporters. "I don't think she intended to do that. It didn't seem like it to me," he added. U.S. CongressOverton said she’s “not currently involved in the details of the study.” Some Senate Republicans alleged former FDA Commissioner Marty Makary didn’t take the review seriously, suggesting he was slow-walking the report. The agency has said it will use the study to determine whether to make changes to mifepristone’s Risk Evaluation and Mitigation Strategy program, which imposes stringent requirements on prescribers for certain drugs deemed to pose risks to patients. During the hearing, some lawmakers also referenced an oversight report committee Republicans released in August claiming that the two leading mifepristone manufacturers have failed to adequately police the doctors and pharmacies that distribute the pills, putting women’s health at risk. The report acknowledges that the companies — Danco and GenBioPro — conduct regular oversight of the groups that prescribe and ship mifepristone, and have disciplined or cut ties with those that refused to be audited. But the GOP senators argued that the low number of incidents of wrongdoing the companies reported to them is suspicious. Overton told Indiana Republican Jim Banks that, if confirmed, she would be committed to ensuring every company follows the law.

FDA commissioner nominee Heidi Overton walked a fine line Thursday responding to senators’ questions about how she’d regulate medication abortion if confirmed, irritating Republicans and Democrats alike and complicating her path to confirmation. “According to FDA standards, the drug is safe and effective as labeled today,” Overton told Sen. Tammy Baldwin (D-Wis.), referring to mifepristone, during a Senate Health, Education, Labor and Pensions Committee hearing. When Baldwin asked if the label for the drug, which is used in more than two-thirds of abortions, should be changed, Overton demurred. “I can’t prejudge the determination of the safety review that's currently ongoing,” Overton, an abortion opponent who serves as a White House domestic policy adviser on health care, said. If confirmed, Overton would lead the Food and Drug Administration as it undertakes a controversial study of mifepristone’s safety that abortion opponents have long demanded. Missouri Republican Josh Hawley, who staunchly opposes abortion, argued during the hearing that Overton’s position on mifepristone clashes with the position the Trump administration has asserted in court battles over federal regulation of the medication. He claimed that because the FDA is not defending on the merits of Biden administration changes to the drug’s oversight that allowed it to be prescribed via telehealth without an in-person evaluation and is instead sticking to procedural arguments about challengers’ lack of standing, that conflicts with Overton’s assertion that the agency believes the drugs are safe and effective as currently labeled. “Right now, there has not been a change to the label,” Overton said. “That safety study is ongoing and very important. Women’s health and women’s safety is a critical piece of this, so there is no change in position.” Hawley said outside the hearing room that he may not support Overton's nomination unless she clarifies her comments on the FDA's position regarding mifepristone's label. "If what she said today is their new position, that would be a complete change in their litigating position, and that would have very dire consequences," he told reporters. "I don't think she intended to do that. It didn't seem like it to me," he added. U.S. CongressOverton said she’s “not currently involved in the details of the study.” Some Senate Republicans alleged former FDA Commissioner Marty Makary didn’t take the review seriously, suggesting he was slow-walking the report. The agency has said it will use the study to determine whether to make changes to mifepristone’s Risk Evaluation and Mitigation Strategy program, which imposes stringent requirements on prescribers for certain drugs deemed to pose risks to patients. During the hearing, some lawmakers also referenced an oversight report committee Republicans released in August claiming that the two leading mifepristone manufacturers have failed to adequately police the doctors and pharmacies that distribute the pills, putting women’s health at risk. The report acknowledges that the companies — Danco and GenBioPro — conduct regular oversight of the groups that prescribe and ship mifepristone, and have disciplined or cut ties with those that refused to be audited. But the GOP senators argued that the low number of incidents of wrongdoing the companies reported to them is suspicious. Overton told Indiana Republican Jim Banks that, if confirmed, she would be committed to ensuring every company follows the law.