Full records on the abortion pill have been kept hidden for 25 years
A May 2026 op-ed penned by J. Marc Wheat,General Counsel for Advancing American Freedom (AAF), and published in The Wall Street Journal (WSJ), is calling for "transparency" surrounding the Food and Drug Administration's (FDA) failure to release the full record relating to the abortion pill mifepristone (200mg)/Mifeprex.
Full records of the abortion pill's approval process under the Clinton administration have been kept hidden for more than 25 years.
The records likely include communications between FDA officials and the White House counsel’s office during the Clinton administration, internal discussions about mifepristone’s original approval application, and materials related to the Population Council.
Questions continue to be raised about the negative health effects the abortion pill has on women.
Numerous Freedom of Information Act requests surrounding the abortion pill have been made, and revealed potential eugenic motives for approving abortion drugs.
A new lawsuit seeks all communications sent to, received by, or copied to the Commissioner of Food and Drugs regarding mifepristone, RU-486, or any form of mifepristone reviewed by the Food and Drug Administration, and all documents related to any meeting with the Commissioner of Food and Drugs in which mifepristone, RU-486, or any form of mifepristone reviewed by the Food and Drug Administration was discussed.
The Backstory:
The abortion pill's approval process began in 1994, when the Bill Clinton Administration pressured French pharmaceutical company and patent owner Roussel-Uclaf to assign the U.S. rights of marketing and distribution of the abortion pill (under the name RU-486) to the eugenic-based Population Council.
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The right to distribute the drugs was later granted to Danco Laboratories, a sub-licensee of the Population Council. Then, by 1996, the Population Council (funded in part with investments from the Susan Thompson Buffett (Warren Buffett) and David and Lucile Packard Foundations) submitted its application for the drug to the FDA — and a series of clinical trials began.
The FDA initially approved the drug, known then as RU-486, for the termination of pregnancy in 2000, in a regimen with a second drug called misoprostol.
As the years went on, use of mifepristone (200mg)/Mifeprex was expanded multiple times, including in 2016, when, with funds from Big Abortion groups like Planned Parenthood, Danco sought to erode safety regulations known as REMS for the drug. In 2023, additional erosions removed the required in-person dispensing of the drug to allow for mail-order and pharmacy dispensing, prompting multiple lawsuits challenging these erosions.
The Details:
But the full record has been kept secret by the FDA for nearly 26 years.
Abortion pill manufacturers have operated in secrecy and made their profits in the dark. Where removing in-person dispensing requirements and halting non-fatal adverse event reporting only aided in their evasion of accountability, transparency must now be demanded throughShow more
Senate HELP Committee GOP
@GOPHELP
NEW: Chairman @SenBillCassidy, @SteveDaines, @SenatorLankford, @SenHydeSmith, and Senator Graham began an investigation into chemical abortion drug manufacturer compliance with @US_FDA mandated safeguards associated with marketing their drugs.
help.senate.gov/rep/newsroom/p…
Even today, 25 years later, the public still has little information about the abortion pill’s approval process in the United States. Were the ‘experts’ associated with pro-abortion organizations or even possibly abortionists? Was the data properly analyzed, or did bias in favor of abortion take precedence over actual safety? We simply do not have these answers, because we have not been given access to the data.
...Interestingly, decades later (May 2020) the ‘record’ about the abortion pill had still not been released, when Columbia University journalists Lauren Mascarenhas and Abigail Brone interviewed early abortion pill advocates while most of the public has no access to the record, these two Columbia University journalists were able to locate one of the FDA’s senior medical reviewers who reportedly “chose to remain anonymous” but admitted, “It’s definitely not standard. It’s not routine; you can look up almost every other drug that I was the primary medical officer for and my name would appear right there on the review.”
The journalists noted that they did look up this anonymous reviewer’s name and found it “listed on at least eight other FDA drug reviews. But no staff names are listed on the review of mifepristone.”
Court Grills FDA on 'Administrative Record'
During oral arguments in the caseAlliance for Hippocratic Medicine (AHM) v. Food and Drug Administration (FDA) in 2023, a tense exchange took place between the FDA’s legal representative and a judge on the United States Court of Appeals for the Fifth Circuit regarding access to relevant documentation about the FDA’s original approval of the abortion pill.
Judge Jennifer Walker Elrod, one of the three judges hearing the case, confronted FDA legal counsel Deputy Assistant Attorney General Sarah Harrington: “I just wanted to ask quickly about the record. We don’t seem to have the administrative record in this case.” Harrington said she had even “checked with the clerk’s office” that morning.
“We absolutely do not have the administrative record,” the FDA’s attorney confirmed.
“Why don’t we?” the judge asked, insisting that the court “absolutely need[s] it.”
Harrington sounded rattled as she admitted that the FDA had not yet assembled the documents, claiming it was due, in part, to the fact that there were “hundreds of thousands of pages.”
“Where is it and how do we get it?” Judge Elrod asked.
“The District Court acted before we were able to produce,” Harrington claimed.
“How long will it take you to get it to us?” Judge Elrod asked.
Harrington was unable to give the judge a precise date, which seemed to frustrate the judge.
Marc Wheat (@AAFLegal) with an all-important question for the FDA in @WSJ:
What’s inside the 125,000+ pages of documents on the chemical abortion pill that the drug agency has been withholding from public scrutiny (some of it for 30 years)?
wsj.com/opinion/what-i…
After two years of litigation, the Food and Drug Administration admitted in March that it has more than 125,000 pages of documents, which it has withheld from public scrutiny for 30 years," wrote Wheat.
These records likely include communications between FDA officials and the White House counsel’s office during the Clinton administration, internal discussions about mifepristone’s original application for approval, and materials related to the controversial Population Council, a nonprofit group co-founded by the eugenicist Frederick Osborn.
Back in June of 2024, Advancing American Freedom (AAF) filed a FOIA request for "copies of communications" between the FDA and various agencies regarding Mifepristone dating back to the 1990s.
"As required by law, the Biden FDA was supposed to release the mifepristone records in June 2024 to comply with a Freedom of Information Act request filed by Advancing American Freedom. It refused to do so," wrote Wheat, adding:
Only after a change in administration and a successful lawsuit did the FDA finally acknowledge the existence of these documents. But even now, agency bureaucrats could slow-walk their release to a few hundred pages per month, meaning it would take decades to reach full disclosure.
Enough is enough. For the sake of women’s health, it’s time for transparency.
Congress asked the FDA to explain its decisions on the abortion pill. The agency produced zero documents.
Stonewalling oversight is not transparency. It's a signal that something is being avoided.
x.com/SenBillCassidy…
U.S. Senator Bill Cassidy, M.D.
@SenBillCassidy
As chair of the HELP Committee and a strong pro-life conservative, FDA’s response to Congress is unacceptable. 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
Judicial Watch has filed numerous FOIA requests surrounding the abortion pill, and has, in some instances, been granted shocking documents suggesting eugenic motives for approving chemical abortion drugs — specifically relating to the Clinton files and RU486.
In September 2023, Judicial Watch submitted a FOIA request regarding stability test results, new drug applications, and related materials of the abortion drug Mifeprex.
More recently, inMay 2026, a lawsuit, seeking "records of communications and meetings" of the FDA commissioner "involving the abortion drug Mifepristone" was filed by Judicial Watch (JW) after the FDA failed to respond to three Freedom of Information Act (FOIA) requests involving communications for "the period April 1, 2025, to the present," JW claimed.
The lawsuit filed against the Department of Health and Human Services (HHS), which oversees the FDA, read in part:
To trigger FOIA’s administrative exhaustion requirement, Defendant was required to make a final determination on Plaintiff’s request by March 25, 2026, at the latest. Because Defendant failed to make a final determination within the time limits set by FOIA, Plaintiff is deemed to have exhausted its administrative appeal remedies.
"All communications sent to, received by, or copied to the Commissioner of Food and Drugs, or to the Commissioner’s immediate office, that concern, refer to, or discuss mifepristone, RU-486, or any generic or branded form of mifepristone approved, regulated, or reviewed by the Food and Drug Administration."
"All documents related to any meeting with the Commissioner of Food Drugs where mifepristone, RU-486, or any generic or branded form of mifepristone approved, regulated, or reviewed by the Food and Drug Administration was discussed, including, but not limited to, calendar events, calendar invitations, talking points, PowerPoint presentations, written or audio recordings, and post-meeting summaries."
"The new FDA leadership needs to get its act together quickly, stop providing special treatment for the abortion pill, and ensure transparency to preserve the rule of law and the public health," Tom Fitton, founder of JW, wrote on X in May.
“The new FDA leadership needs to get its act together quickly, stop providing special treatment for the abortion pill, and ensure transparency to preserve the rule of law and the public health," @TomFitton (3/3). jwatch.us/XqCqZf
Thank you, @SenatorLankford.
Lankford: Will the FDA move to give transparency on the chemical abortion pill? People should know "side effects on this drug and there should be reporting."
RFK Jr: "...We need to know what adverse events are, we need to understand the safety ofShow more
Until the full record on this approval process is revealed, the American public should continue to question the purported safety of self-managed abortion for women; we already know it has been unsafe for 7.5 million preborn children and counting, who have died because of it.
"For three decades, Democratic and Republican administrations have kept the information surrounding the initial approval of the abortion pill under lock and key," John Shelton, Vice President of Policy at AAF wrote on X.
" Sunlight is the best disinfectant. It’s high time the Trump administration released the RU-486 files," he added.
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Abortion Pill
