‘Unacceptable’: Republicans frustrated with FDA chief Makary’s lack of answers on abortion pill

Senate Republicans want to know what’s going on with the abortion pill behind the scenes at the Food and Drug Administration, but Commissioner Marty Makary hasn’t exactly been forthcoming.

Dr. Makary punted in response to a Senate letter requesting a status report on the FDA’s review of mifepristone, one of two pills used in the at-home abortion protocol, as well as details on the agency’s much-criticized decision to approve a generic version of the drug in October.

“Since mifepristone for medical termination of early pregnancy is the subject of pending litigation, we are unable to fully respond to these questions at the present time,” Dr. Makary said in his Thursday reply. “However, I assure you that the FDA is reviewing the evidence and we will keep you informed as the review progresses. This review will help ensure that the FDA’s decisions are grounded in Gold Standard Science and rigorous, transparent, and objective evidence.”

Senate Health, Education, Labor and Pensions Committee Chairman Bill Cassidy, a medical doctor who led the Oct. 16 letter, called his response “unacceptable.”

“As chair of the HELP Committee and a strong pro-life conservative, FDA’s response to Congress is unacceptable,” said the Louisiana Republican said in a Friday statement, which included the release of Dr. Makary’s letter.

“Republicans have been pressing FDA to provide answers on the status of its promised safety study of the chemical abortion drug and information about the second generic’s approval,” Mr. Cassidy said. “The American people deserve to know why HHS and FDA continue to ignore their responsibility to safeguard mothers and unborn children from this harmful drug.”

Dr. Makary also came under criticism from Sen. Josh Hawley, Missouri Republican, who asked him in a Wednesday letter about a Bloomberg report that the FDA is slow-walking its mifepristone safety review until after the midterm elections.

In his letter, Mr. Hawley said that “it is unclear whether you are conducting an independent safety review at all. This is totally unacceptable.”

Susan B. Anthony Pro-Life America responded to the Bloomberg article by calling for Dr. Makary’s resignation, but the commissioner chalked up the report to “rumors.”

“There’s a lot of rumors that are circulating out there,” he told The Daily Signal in a Tuesday interview. “We live in a very partisan time, so you’re going to see the echo chamber of social media sort of magnify rumors, things that are just not true.”

He said there has been “an ongoing review of mifepristone” as part of the standard Risk Evaluation and Management Strategies process, as well as an additional safety study in the “data acquisition phase.”

“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,” said Dr. Makary. “What we find in our study will be put out there in the literature, and it can be part of that broader discussion nationally. We’re not going to decide what the results are before we’ve done the study.”

In his letter to Mr. Cassidy, the commissioner said the agency’s data from 2000 to 2012 shows there were 2,740 “adverse events” experienced by women after taking the abortion pill, including 416 events involving “blood loss requiring transfusions.”

That was before the Obama and Biden administrations began relaxing safeguards on mifepristone. In 2000, the FDA required three in-person office visits, but now, the pills may be obtained via telehealth with no in-person consultation and delivered through the mail.

In 2016, the agency stopped requiring the reporting of nonfatal adverse health events.

SBA Pro-Life America said Friday that Dr. Makary “admits abortion drugs caused hundreds of women to need blood transfusions — before the agency just stopped collecting data. Yet Biden’s mail-order drug rule remains inexplicably in effect.”

The group added: “The admin needs to stop this NOW.”

A surgeon who taught at the Johns Hopkins University School of Medicine, Dr. Makary was a leading critic of vaccine mandates for those other than health care workers during the COVID-19 pandemic.