FDA commissioner pledges to investigate mifepristone

The Hill

03-06-2025

Food and Drug Administration Commissioner Marty Makary committed to reviewing the abortion drug mifepristone in a letter sent to Senator Josh Hawley (R-Mo.).
'As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of early pregnancy,' Makary wrote to Hawley.
'As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with the professional career scientists at the Agency who review this data,' he added in the letter.
Makary did not provide any further details about the forthcoming review since the abortion drug is a part of ongoing litigation.
Hawley has previously pressured the agency to review the drug. Last month, the senator sent a letter to Makary urging him to review new data released on mifepristone and to 'restore critical safeguards' on the drug's use.
In the same letter, he also criticized Makary for stating that he has 'no plans to take action' on mifepristone during a journalism convention.
The data Hawley referred comes from a study published in April by The Ethics and Public Policy Center, a conservative think tank with a mission to 'pushback against the extreme progressive agenda.'
The group claims that nearly 11 percent of women who undergo an abortion using mifepristone experience a 'serious adverse event,' which is a far higher rate than the 0.5 percent rate determined in other clinical studies.
But the study is deeply flawed and filled with what researchers have called 'junk science.' The study does not clearly state the database where it obtained the nearly 865,000 insurance claims on prescribed mifepristone abortions.
The research breaks down the 'serious adverse events' by category but places the majority of those events into a vague category called 'other abortion-specific complications.'
The FDA first approved the use of mifepristone for an abortion as part of two-drug regimen with misoprostol in 2000.
Medication abortions do not need to take place in a clinic setting with patients able to pick up the pills at a clinic to then take home or receive them in the mail.
More than 100 scientific studies have been conducted examining the safety and efficacy of mifepristone and misoprostol, with all of them finding that the drugs are a safe way to end a pregnancy.
Most abortions in the U.S. are medication abortions. In 2023, 63 percent of all abortions provided by clinicians in the country were medication abortions, according to data from the reproductive health and rights group the Guttmacher Institute.
Three Republican-led states — Idaho, Missouri and Kansas — filed a lawsuit against the FDA challenging its previous approval of mifepristone. The Supreme Court dismissed the case last year, arguing that private parties did not have a legal basis to challenge access to the drug.
But a Texas federal judge ruled in January that the three states could resume their lawsuit aimed at restricting access to mifepristone.
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has also pushed for a review of the drug. President Trump, after winning the election last November, said it was 'unlikely' that he would revoke access to the drug.