FDA Abortion Drug Review Update
Dr. Marty Makary, the Commissioner of the Food and Drug Administration (FDA), addressed concerns regarding the review process for the abortion drug mifepristone. Recent reports suggested he was delaying the review, but he clarified that they are actively engaged in a detailed study to validate existing data.
In an exclusive interview, Makary mentioned that he, along with Secretary of Health Robert F. Kennedy Jr., committed to examining the safety of abortion drugs after a study from the Ethics and Public Policy Center indicated that around 11% of women face adverse effects following the pill regimen. This delay in review has stirred criticism from leading pro-life organizations, some even calling for his removal.
Makary asserted his personal responsibility for the review process. “Ultimately, I’m responsible for this analysis, which will report directly to me,” he stated, emphasizing his involvement.
Currently, the FDA is in what it calls the “data acquisition phase” of the review for the abortion pill. “Many members of Congress have said this is a timely opportunity to conduct a thorough study, so we’re gathering the right data,” he explained.
He mentioned that he cannot predict the outcomes or timing of the review, noting that recent government shutdowns have caused some delays. However, when results are ready, they will be made public.
Detailing the review process, Makary explained that once the data is collected, the FDA would analyze it to ensure completeness and assess how it affects study design. “If we find missing data, we’ll adjust the study accordingly,” he added.
He also noted that routine steps in good data analysis include repeating studies and involving multiple reviewers. Makary stressed his commitment to conducting the review properly, despite the swirling rumors about his pace.
“There’s a lot of misinformation out there, magnified by social media,” he pointed out, reaffirming that there has been continuous review of mifepristone.
Additionally, he mentioned that the Risk Evaluation and Mitigation Strategies (REMS) policy mandates ongoing medication reviews, keeping an eye on potential new drug interactions or complications that may not have been recognized before.
The Ethics & Public Policy Center study revealed that approximately 11% of women may experience severe events such as sepsis or hemorrhaging within 45 days following a mifepristone abortion. This has rekindled calls to reintroduce in-person dispensing of the drug.
In April 2021, the Biden administration’s FDA eliminated the requirement for in-person dispensing, allowing women to receive the medication via telehealth and mail. Since then, the in-person dispensing rule has not been enforced.
A recent poll indicates that about 70% of American voters are skeptical about the safety of mailing abortion drugs. When asked about the safety of taking the abortion pill without a doctor’s visit, Makary noted that the previous study lacked detailed patient characteristics, hence their need for a more comprehensive analysis.
On October 2, the FDA approved a second generic version of the abortion pill, shortly before the government shutdown, which faced backlash from pro-life advocates. Makary explained that the FDA was legally obligated to approve the drug to avoid potential lawsuits. “The law requires approval for drugs similar to existing branded options,” he said, clarifying the agency’s limited discretion in such cases.
He concluded by emphasizing that while they weigh risks and benefits for branded drugs, the approval process for generics is bounded by clear legal guidelines.
