Senator Hawley Seeks Clarification on Mifepristone Review

Senator Josh Hawley from Missouri is pressing for clarity from Dr. Marty Makary, the Food and Drug Commissioner, regarding his review of the abortion pill mifepristone. This follows Makary’s recent comments to The Daily Signal, where he didn’t establish a timeline for the review process.

In a letter, Hawley called attention to Makary’s earlier statement indicating that an ongoing review was part of a policy known as REMS, but Hawley argued that this wasn’t what had been promised. He emphasized that a thorough study considering all safety data was expected, rather than just standard monitoring applied to many medications.

Hawley also shared on Twitter, expressing concerns over the safety of mifepristone, urging Makary to reinstate safety regulations from the Trump administration and stop what he views as delays in the full safety review. He used the phrase “Enough is enough” to punctuate his frustration.

In a response to The Daily Signal, Makary noted that the review of mifepristone is currently in the “data acquisition phase,” despite speculation about delays surrounding the midterms.

He defended the review process, mentioning that while they conduct ongoing assessments, a more robust study is intended to either validate or challenge existing research on the drug.

Despite commitments from Makary and Robert F. Kennedy Jr. from the Department of Health and Human Services to conduct a safety review of abortion medications, Hawley expressed doubt regarding the independence of this review.

The senator described the situation as “totally unacceptable,” stressing that political considerations should never compromise women’s health.

A study by the Ethics & Public Policy Center revealed that around 11% of women may face severe complications, such as sepsis or hemorrhaging, within 45 days of using mifepristone. This has sparked discussions about reinstating in-person dispensing requirements for the medication.

Hawley reiterated his call for the reinstatement of safety regulations from Trump’s presidency and accused Makary of neglecting mifepristone’s safety review.

In reply to Hawley’s inquiries, HHS press secretary Emily Hilliard assured that the FDA’s thorough scientific reviews are necessary to uphold high standards and quality.

Hawley demanded explicit answers particularly about the FDA’s actions concerning the safety review, posing questions about its independence and timelines.

When pressed about the review timeline, Makary admitted that he could not offer a prediction on its results or when it would wrap up. He noted that previous disruptions had set them back but affirmed that results would be shared publicly when ready.

Hawley further inquired if there were plans to revise the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) to reinforce safety measures established during the Trump administration.

Addressing concerns regarding the safety of taking mifepristone without a prior doctor’s consultation, Makary pointed out that a recent study lacked detailed patient data, which may limit its comprehensiveness.

He dismissed claims of delaying the review as unfounded social media rumors, suggesting that partisan narratives, fueled by online platforms, might be distorting the facts. He insisted that an ongoing review of mifepristone was indeed taking place.

However, the pro-life organization, Susan B. Anthony Pro-Life America, criticized the timeline, stating that nearly a year into the current administration, the review had not progressed beyond data collection, characterizing it as “slow-walking.” They reiterated their call for Makary’s removal.