The U.S. Food and Drug Administration is reportedly opening up a politically-charged investigation into the safety of the abortion pill mifepristone — a drug long considered to be the gold standard for early medical abortions.
The investigation, spurred by conversations with anti-abortion groups and an October deadline from a Louisiana judge, is expected to take around six months, Trump administration officials told The Wall Street Journal Thursday night.
The agency told The Independent on Friday that it disputes characterizing the investigation as new.
“The FDA has been actively working on a science-based safety review of the mifepristone REMS for months, as the agency has stated publicly and in court filings,” a spokesperson for the agency, which is overseen by Department of Health and Human Services Secretary Robert F. Kennedy Jr., said.
“Any reporting suggesting otherwise, including that a study is just being started, is either false or based on a fundamental misunderstanding of how complex scientific safety studies work,” they said.
The drug has been on the market for decades. First approved by the agency in 2000, it is currently allowed for use up to 10 weeks of pregnancy.
Over the past two decades, more than 7.5 million women have taken the drug, according to an assessment from U.C. San Francisco’s Advancing New Standards in Reproductive Health program.
Right now, the FDA continues to say on its website that the pill is safe for use as indicated. Fewer than 0.5 percent of patients who take mifepristone have serious adverse reactions, the American Medical Women’s Association reports, “making mifepristone safer than ibuprofen, penicillin and Viagra.”
Abortion rights groups allege that the administration’s investigation goes against established science.
“The FDA’s review is a politically motivated farce,” Alexis McGill Johnson, the president and CEO of the sexual healthcare non-profit Planned Parenthood Action Fund, said in a statement shared with The Independent.
“Mifepristone is safe and effective. We know it, the FDA knows it, and the more than 7.5 million people who’ve used mifepristone for abortion and miscarriage care over the past 25 years know it too,” she said.
“Mifepristone is safe and effective — hundreds of high-quality studies have made that overwhelmingly clear. Citing junk science, the Trump Administration initiated this review with the politically motivated goal of making abortion pills harder to access,” Liz Wagner, Senior Federal Policy Counsel at the Center for Reproductive Rights, said.
“We are deeply concerned about the news that the FDA has initiated what can only be described as a politically motivated ‘safety review’ of the abortion drug mifepristone,” Amy Friedrich-Karnik, director of federal policy for reproductive health research group the Guttmacher Institute, also said in a statement shared with The Independent. “More than 100 studies and decades of real-world evidence show that mifepristone is safe and effective, both when provided in person or by telehealth.”
“We call on the FDA to withstand political pressure from the White House and outside anti-abortion groups and conduct a fair, science-based review that lives up to its own past standards of excellence and integrity,” she said.
Following a request from RFK Jr.., Marty Makary, the former commissioner of the FDA, had promised he’d launch the study before his ousting last month.
He said that he’d need new data systems to do it, but the study will use existing drug-safety surveillance systems and potentially include analysis from a contractor, the officials said, per The Journal.
Friedrich-Karnik said that Makary’s resignation was because he had attempted to remain independent as an agency head — and did not follow the political directives of the White House.
“That the FDA is now confirming that it is conducting a review of mifepristone in response to junk science-fueled false narratives from anti-abortion groups and policymakers adds to the alarming perception that the FDA has become overtly politicized,” she said.
Officials from Students for Life of America told The Journal they have questions about the proposal.
“This study needs to be thorough,” said Kristi Hamrick, spokeswoman for Students for Life of America. “We have a lot of unanswered questions before we can be excited.”
Anti-abortion groups have been pushing for action from the Trump administration since he took office for his second term and on the heels of a recent ruling from the Supreme Court that keeps the pill available using telehealth services.
Mifepristone has been a popular target in the years since it was approved.
Anti-abortion state legislators filed more than 100 bills to restrict access to abortion drugs, or sought to ban them altogether. After the Supreme Court overturned Roe v Wade in 2022, more than a dozen states effectively outlawed all abortions in most circumstances.
It remains to be seen what the study’s results will bring, or where the fight goes from here.
“This study must be prepared for the scrutiny that it’s guaranteed to face after its release,” Gavin Oxley, spokesman for Americans United for Life, told The Independent. “Methodology must be robust, sourced from real-world data, and not a single corner can be cut. When the FDA inevitably reveals the substantial harms to women from mifepristone, there must be no questions left unanswered.”
”In 2016, the FDA told doctors, hospitals and emergency rooms that they no longer needed to report complications or ‘adverse’ events that result from the usage of mifepristone. After 10 years, we’re happy to see the agency once again reviewing the so-called ‘safety’ of this drug,” Carol Tobias, president of National Right to Life, said.
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