The Secretary of Health and Social Services, Robert F. Kennedy Jr., has instructed the Food and Drug Administration to carry out a Miffepristone security examination, a pill used in most American abortions. Kennedy said this week that the exam was justified due to a new “alarming” report on serious adverse events published last month.
“It is clear that it indicates that, at the very least, the label should be modified,” he told Senator Josh Hawley, R-MO on Wednesday. “I asked Marty Makary, who is the director of the FDA, to do a complete exam and to present himself.”
THE report in questionWho has not been evaluated or published in a medical journal, claims to find a serious complications of 22 times higher in mifepristone than reported by the FDA. He calls on the agency to “investigate the damage more than mifepristone causes women” and to “fully reconsider its approval”.
It was published online in April by the Center for Ethics and Public Policy, a conservative reflection group which says that it promotes Judeo-Christian traditions. The center was to the consultative council of the 2025 projecta right -wing political initiative that seems to have informed Many recent actions by President Donald Trump.
A few days before the report, the FDA commissioner, Marty Makary said said He did not intend to take action on Mifepristone Unless new data suggests that there was a security problem.
Hawley, who has Voted constantly to limit access to abortion,, called Makary last month “Follow these new data” and restore certain restrictions that have made mifepristone more difficult to obtain, such as the requirements for the drug to be distributed in person by a doctor.
While Data richness has shown that less than 0.5% of women who take mifepristone have serious undesirable effects, the report claims that the real number is around 11%.
Researchers who study reproductive health have said that this is equivalent to the science of junk food and exaggerates the risks of the drug.
“We must all be alarmed that people responsible for our public health establishments call for an examination of science based on an unsuitable and defective report,” said Dr. Upadhyay, public health scientist at the University of California on Thursday.
“Rigorous studies, including some of the mine, have confirmed that this medication can be used safely at home after consultation with a clinician,” she added.
The report indicates that his analysis was based on 865,727 insurance complaints corresponding to women who were prescribed abortion pills, but do not reveal which database it used, by pouring a basic principle of scientific research. Several external researchers have noted that the definition of the “serious unwanted event” report is wide enough to include minor side effects such as routine bleeding. But the reports of the report declared on the website of the center they Light or moderate events excluded.
Abortion procedures after a medication, abortion has nevertheless been classified as “serious”, unlike medical consensus. Mifepristone’s label already notes that the drug does not work in approximately 2.6% of cases, and doctors say that the failure rate can reach 5%. The report also lists extraordinary pregnancies, which do not result from taking mifepristone, as serious events.
Alina Salganicoff, director of the KFF Women’s Health Policy Program, a research and press research organization, said the report “does not receive generally accepted research standards”. The analysis of insurance complaints is not an effective way to examine the results of abortion, she added, because “many abortions, and in particular previous abortions, are not paid with insurance”.
Rachel Jones, principal researcher at the Guttmacher Institute, a research organization that supports access to abortion, said that the relationship seems to be motivated by ideology rather than science.
“The FDA is generally based on clinical studies and clinical research, and that is not what it is. It should not have an influence on current policies,” she said.
The authors of the report postponed these criticisms, writing On the Center website That the peer examination process is biased against groups opposing abortion and leave “no possibility of publishing an analysis evaluated by peers which offer major substantial criticisms of the abortion or abortion pill”.
“Now that the biggest study of the abortion pill has revealed the truth that it is neither safe nor effective, the abortion industry has chosen to lie on our conclusions to protect its profits at a huge cost for women’s health,” said Hunter Estes, director of communications at the Center for Ethics and Public Policy, in a statement.
DRE Christina Francis, CEO of the American Association of Pro-Life Obgyns, said that the report is a signal that the FDA must examine the security of Mifepristone.
“We have been asking the FDA for years to make a more in-depth examination of the real complications rate in the real world,” she said. “For me, this report could not happen early enough.”
HHS, which manages media investigations in the name of the FDA, did not respond to a request for comments.
Reproductive health researchers have said that the release of erroneous studies is one of the many tactics used by anti-abortion groups to limit access to mifepristone, in addition to depositing prosecution and Press federal officials.
“Persons and organizations wishing to be prohibited produces these types of articles more often,” said Jones.
Deceptive studies have played a role in a previous judicial challenge to access to Mifepristone who was ultimately thrilled. In a decision that Suspended Mifepristone approval In 2023, the American district judge Matthew Kacsmaryk quoted studies of an anti-abortion group which were later retracted by a medical publisher.
Prosecutors General of Idaho, Kansas and Missouri tried to relaunch the trial in October, depositing a case before the same Federal Court in Texas. But the Trump administration earlier this month told the judge to reject him.
Julia Kaye, principal lawyer for the ACLU freedom of reproduction project, said during a press call that the continuation of the case could have undermined the legal defenses of the administration in other in progress. Other legal experts see it as an effort to avoid taking a firm position on abortion, which, according to Trump, should be left to individual states.
In his confirmation audiences, Kennedy promised to align with Trump on the issue. He also suggested on Wednesday that Trump would have the last word on how mifepristone is regulated in the United States
“I think the policy changes will finally go through the White House, by President Trump,” he said.