Abortion advocates have pursued a 40-year technological strategy to substitute chemical abortion for surgical abortion. Funded by billionaires and foundations like Rockefeller, they have zealously worked for a chemical abortifacient that can be over-the-counter (OTC) and do-it-yourself (DIY)—without any doctors. Americans United for Life has stood against chemical abortion from the beginning of these efforts.
The Impact/Significance of AUL’s 1995 Citizen Petition Against RU-486
The French pharmaceutical company Roussell-Uclaf developed what they then called RU-486 in the early 1980s for other medical purposes, but researcher E.E. Baulieu found that it might be used as an abortifacient, and the French Government approved RU-486 for the French medical market in 1988. During President Bill Clinton’s first week in office in January 1993, he issued an order that his administration would aggressively work to bring RU-486—now known by its generic name, mifepristone—to the U.S. medical market as fast as possible. Seeing the threat, and knowing some of the risks of mifepristone, AUL, working through 1993-1994, filed a 100+-page Citizen Petition (CP), as required by law, along with many members of Congress, in an attempt to block the Clinton FDA’s approval of RU-486 in February 1995. It exhaustively explored the medical data and explained the risks—then-known—of RU-486. The CP also warned of the thin medical evidence that then existed, which could not justify the approval of RU-486. It also exhaustively explained federal law that the FDA would have to abide by.
The FDA failed. Although the AUL CP did not stop the approval of RU486 by the Clinton FDA just before the 2000 elections, it publicly exposed the risks and identified the legal and medical standards that the FDA would have to meet to approve RU-486.
Pressured by the Clinton Admin, the FDA did not meet those standards.
The medical evidence and the legal standards have guided pro-life work in the courts and legislatures ever since. In 2002, a second Citizen Petition was filed by the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG). In 2006, and over the past decade, more than a dozen states have sought to fill the federal regulatory vacuum by enacting safety regulations to protect women from the two-drug regimen of mifepristone and misoprostol.
After the Supreme Court decides the Mississippi abortion case (Dobbs), some states may go further and prohibit chemical abortion altogether. To see abortion advocates’ vision of DIY abortions for women, see the Feb 2022 VICENews video.
Excerpts From News Coverage of 1995 Petition
Excerpt from NY Times:
“Americans United for Life, a group based in Chicago that opposes abortion, said at a Washington press conference that it had filed a citizens petition with the F.D.A. demanding that it apply the strictest possible standards in reviewing the drug. The group argued that the agency should not use data from foreign studies, including those involving tens of thousands of women who used the drug in France and Britain.
Dr. Camilla Hersh, a physician and spokeswoman for the coalition, said doing so could contribute to “bad medicine and sloppy science that ignores women’s health and safety.”
Americans United for Life was urging in its press conference at the National Press Club that RU-486 face strict approval standards.”
Excerpt from AUL’s Petition:
“In 1995, Americans United for Life filed a Citizen Petition with the U.S. Food and Drug Administration to request that the Commissioner refused to approve any NDA for RU 486 for use as a pharmaceutical abortifacient that does not contain adequate evidence that the drug has undergone nonclinical and clinical safety and effectiveness trials. The basis for AUL’s request was the statutory mandate of the FDA to withhold approval of any NDA that lacks sufficient data to establish that a drug is safe and effective for its intended use. Secondly, the approval of any NDA that is devoid of the appropriate safety and effectiveness data would not only be an express violation of the FDCA, but also an arbitrary and capricious agency action.
AUL was concerned that RU-486 could be approved in the United States based largely on foreign data, with only limited safety data generated from studies conducted in the U.S. because approval based on possibly invalid foreign data and limited safety data would expose patients to significant and unreasonable adverse health risks, petitioners respectfully request that FDA consider the following factors in reviewing any NDA for RU 486.”
