FIRST ON THE DAILY SIGNAL—Food and Drug Administration Commissioner Dr. Marty Makary responded to a report saying he is putting off the review of the abortion drug, mifepristone.

“We do an ongoing review, but we’re also engaging in a robust study that can serve to validate or not validate other numbers that have been put out there in the literature,” he told The Daily Signal in an exclusive interview. 

Makary and Secretary of Health Robert F. Kennedy Jr. have pledged to do a review of the safety of abortion drugs following a study from Ethics and Public Policy Center which showed 11% of women experience adverse effects after taking the pill regimen. Bloomberg reported that Makary is slow walking the review, prompting calls from leading pro-life groups for him to be removed from his post. 

Makary said he is personally responsible for the review. 

”Ultimately, I’m responsible, and so this analysis is going to be done under my auspices, and it’ll be reported up to me,” he said, “and I’m going to be involved.” 

The FDA is currently in the “data acquisition phase” of the abortion pill review. 

“Appropriately, many members of Congress have said, ‘Hey, this is a good time to check in and do a robust study.’ So, part of a robust study is data acquisition,” he said. “And so, we’re in that data acquisition phase to get the right data to be able to do this study.” 

Makary said he is unable to predict the “results or the timeframe” of the review. 

“The shutdown was a little bit of a setback in that, but we’re gonna do it and whenever the results are available,” he said, “we’re gonna make them public.” 

He laid out the plan for the review. Once the data has finished coming in, the FDA will review it and ensure there are no missing data fields that change the way the analysis is designed. 

“If there are, then you change the design of the study and you account for how the landscape of the data actually is and the way it presents,” he said. “And then you look at the preliminary exploratory results, and then you change the analysis to account for confounding variables.” 

Next, the FDA will “repeat and validate.” 

“These are all routine steps in robust data analysis,” he said. “Studies are often repeated, done by multiple reviewers or statisticians. So, we’re going to do it the right way. And look, I know there are a lot of voices in this space, but I’m committed to doing this the right way.” 

The former Johns Hopkins professor blamed the rumor mill for Bloomberg’s story saying he has slow walked the mifepristone review. 

“There’s a lot of rumors that are circulating out there,” he said. “We live in a very partisan time, and so you’re going to see the echo chambers of social media sort of magnify rumors, things that are just not true. There has been an ongoing review of mifepristone.” 

The Risk Evaluation & Mitigation Strategies, or REMS, policy already requires the FDA to perform an ongoing review of medication, Makary said. 

“There’s always an ongoing review of that medication, and we need to be open to the fact that maybe there’s a new drug interaction that was not appreciated,” he said. 

Makary said it’s possible “there’s a complication that was not recognized previously” with the abortion pill. What the FDA finds in the study will join the “broader discussion nationally,” he said. 

“We’re not going to decide what the results are before we’ve done the study,” he said. “We’re doing the study the right way. And when you do the study the right way, and I’ve done dozens of these studies as a Johns Hopkins professor, you gotta do the studies in data the right way with the right pace.” 

The Ethics & Public Police Center study found that about 11% of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion. This has led to calls to reinstate the in-person dispensing requirement for mifepristone.

In April 2021, the Biden administration’s FDA stopped requiring that abortion drugs be dispensed to women in person, which allowed women to receive them through telehealth appointments and by mail. The FDA has not enforced the in-person dispensing requirement ever since.

Seven out of 10 American voters say they don’t think it’s safe for abortion drugs to be sent via mail, according to a McLaughlin & Associates poll. 

When asked by The Daily Signal if it’s safe for women to take the abortion pill at home without seeing a doctor first, Makary said the Ethics & Public Police Center study “was done in claims data, so it didn’t have granularity into the patient characteristics in a way that many researchers would want to have.” 

“That’s one of the reasons why we are doing a bigger, more robust study,” he said. 

The FDA approved a second generic version of the abortion pill on Oct. 2, shortly before the government shutdown, another move which sparked pro-life backlash. Makary said the FDA had to approve the drug or get sued. 

“There’s a law that requires the FDA to approve a molecule if it’s similar to a branded molecule, so we had no discretion,” Makary told The Daily Signal. “If we chose to look at that application and say, no, we’re not going to approve this, we’d 100% get sued, and we’d 100% lose.”

“It would all happen very quickly because the law is very clear now with drugs that we approve as new branded drugs,” he said. “It’s a very different law. So we have discretion to weigh risks and benefits. But when it comes to generic compounds, the law is pretty clear.” 

The post EXCLUSIVE: Makary Responds to Report Saying He Slow Walked Abortion Pill Safety Review  appeared first on The Daily Signal.