Health and Human Services Secretary Robert F. Kennedy Jr. Kennedy said this week that the review was assured by a "shocking" new report on serious adverse events released last month.

He told Senator Josh Hawley at a Senate budget hearing Wednesday, who told Senator Josh Hawley. “I have asked FDA Director Marty Makary to conduct a complete review and report.”

The report has not been peer-reviewed and has not been published in medical journals, claiming to have a 22-fold higher rate of severe complications than the FDA-reported mifilzogenic agent. It called on the agency to “further investigate the harm of miketogen on women” and “reconsider its endorsement.”

It is published online by the Center for Ethics and Public Policy, a conservative think tank that claims it promotes the Jewish Christian tradition. The center is located on the 2025 Project Advisory Committee, a right-wing policy initiative that appears to have informed President Donald Trump of recent actions.

A few days before the report was released, FDA Commissioner Marty Makary said he had no plans to take action against mifepristone unless new data suggests safety issues.

Hawley, who has always voted for restricting access to abortions, called on Makary last month to “follow these new data” and restore certain restrictions that make mifretone difficult to obtain, such as a requirement for doctors to distribute medications themselves.

Although large amounts of data show that less than 0.5% of women taking mifyone have adverse reactions, the report says the real number is about 11%.

Researchers studying reproductive health say this is equivalent to junk science and exaggerates the risks of drugs.

"We should all be shocked that people in our public health agencies are in charge of our public health agencies call for a review of science," Dr. Ushma Upadhyay, a public health scientist at the University of California, San Francisco, said Thursday in a call with news members.

"Ratifying research, including some of my own, has proven that the drug can be used safely at home after consulting with a clinician," she added.

The report said its analysis was based on 865,727 insurance claims that correspond to women who prescribed abortion medications, but did not disclose the database they used to overturn the basic tenet of scientific research. Some outside researchers pointed out that the report's definition of "severe adverse events" is broad enough to include smaller side effects such as routine bleeding. But the authors of the report said on the Center's website that they ruled out mild or moderate events.

However, the abortion procedure after abortion is still classified as “serious”, which violates medical consensus. Mifepristone's label has pointed out that the drug does not work in about 2.6% of cases, and doctors say the failure rate could be as high as 5%. The report also lists ectopic pregnancy, which is not a serious incident caused by taking mifepristone.

Alina Salangicoff, director of the Women’s Health Policy Program at KFF, a health policy research and news agency, said the report “is not accepted recognized research standards.” She added, “Analyzing insurance claims is not an effective way to see the outcome of abortion, because “many miscarriages, especially early miscarriages, do not pay insurance.” ”

Rachel Jones, principal research scientist at the Guttmacher Institute, a research organization that supports miscarriage visits, said the report appears to be driven by ideology rather than science.

"The FDA usually relies on clinical research and clinical research, which is not anything. It should not have any impact on current policies," she said.

The authors of the report objected to these criticisms and wrote on the center’s website that the peer review process was biased against the anti-abortion groups and “had no chance to publish peer-reviewed analyses that provide an analysis of significant substantive criticisms of abortion drugs or abortion.”

"Since the largest abortion pill research ever revealed the fact that it is both safe and ineffective, the abortion industry has chosen to lie to protect its profits and protect its profits at huge women's health costs," said Hunter Estes, director of communications at the Center for Ethics and Public Policy.

Dr. Christina Francis, CEO of the American Pro-Life Life Association, said the report shows that the FDA needs to look more closely at the safety of mifeketone.

“For years, we have been asking the FDA to conduct a more thorough review of the real-world complication rates,” she said. “For me, this report is not fast enough.”

HHS handled media inquiries on behalf of the FDA and did not respond to requests for comment.

Reproductive health researchers say that in addition to litigation and lobbying federal officials, release of flawed research is one of many strategies for the anti-abortion population to limit mifepristone access.

"People and organizations who want to have abortions produce these types of papers more often," Jones said.

Misleading research played a role in the previous legal challenge of the mifepristone visit that the Supreme Court finally threw out. In a decision to temporarily suspend mifepristone approval in 2023, U.S. District Court Judge Matthew Kacsmaryk cited a study by an anti-abortion organization that was later withdrawn by medical publishers.

Attorneys general in Idaho, Kansas and Missouri tried to resume lawsuits in October, filing the lawsuit in the same federal court in Texas. But the Trump administration told the judge earlier this month to dismiss it.

Julia Kaye, a senior staff attorney for the ACLU Reproductive Freedom Program, said in a news call that filing a lawsuit may undermine the government's legal defense in other ongoing lawsuits. Other legal experts see it as an effort to avoid a firm stance on abortion, which Trump said should be left to individual countries.

Kennedy promised to align himself with Trump during the confirmation hearing. He also advised Trump on Wednesday on the final decision on how to regulate mifetone in the United States

"I think policy changes will eventually pass through the White House through President Trump," he said.