CV NEWS FEED // On Good Friday, Texas-based federal Judge Matthew Kacsmaryk stayed the U.S. Food and Drug Administration’s (FDA) approval of the abortion-inducing drug mifepristone in what CatholicVote Communications Director Joshua Mercer called “the most significant victory for the pro-life movement since [Dobbs].”
Just minutes after the Texas ruling, however, another federal judge issued a completely opposite ruling, directing the FDA to keep allowing use of the drug. These “dueling” rulings set the stage for a continued debate over the constitutionality of chemical abortion that might culminate with a Supreme Court case to settle the matter.
The Untold History of Mifepristone
After a controversial political push from the Clinton administration, the FDA first authorized mifepristone on September 28, 2000, marking the first time that chemical abortion was sanctioned in the United States.
Then-First Lady Hillary Clinton, who at the time was running for New York’s open U.S. Senate seat, applauded the FDA’s unprecedented maneuver. She stated:
This decision will help ensure that women in the United States will have access to a safe and effective option that women in other countries have had for years. In the Senate, I will fight hard to protect a woman’s right to choose and ensure that these difficult decisions are kept between a woman and her doctor.
At the time, mifepristone, also known as RU-486, had been legal in Europe for 12 years, having been first approved for use in France in 1988. Prior to its authorization of the drug, the Clinton FDA met with Roussel-Uclaf, the French pharmaceutical company that had developed it, as well as the Population Council, a pro-abortion, pro-population control activist group founded by John D. Rockefeller III.
Lawyer Erik Baptist, a senior counsel at Alliance Defending Freedom, explained this strange, unprecedented collusion spearheaded by the Clinton Administration in a recent interview with CatholicVote’s Erika Ahern.
“On [President Bill Clinton’s] second full day in office, he directed his cabinet to find ways to bring RU-486, or mifepristone, into the United States, and that’s exactly what they did,” Baptist said:
First, they had to strongarm the French manufacturer [Roussel-Uclaf], who wanted no part of the United States market to donate for free, the U.S. rights to RU-486 to Population Council… The FDA worked hand-in-hand with the Population Council to get this drug approved.
The pro-life legal watchdog group Judicial Watch has pointed out that in addition to pressuring a big-pharma conglomerate from France, the Clintons also pushed Hoescht AG to come onboard with the plan. The German company was at the time Roussel’s majority shareholder:
The [Clinton administration] and the FDA were willing to place political pressure on two foreign governments [France and Germany] to accomplish the task of approving an abortion pill. This was not a life-saving medication or a drug that cured cancer. This was a drug which was being sought for one purpose and one purpose alone: the intentional death of prenatal humans. And for what reason? The ability to satisfy a financially and politically powerful group of abortion advocates.
Judge Kacsmaryk noted this in the 67-page ruling he delivered last Friday. “The purpose of the FDA-organized meeting was ‘to facilitate an agreement between those parties to work together to test [mifepristone] and file a new drug application,’” he wrote. “In fact, for their negotiations [to be] successfully concluded,” then-U.S. Secretary of Health and Human Services (HHS) Donna Shalala, a close Hillary Clinton confidante, “believed American pressure on the French firm was necessary.”
China is Involved
To make matters even more complicated, it eventually became known that a third foreign company, this one from the communist-controlled People’s Republic of China, was involved in the manufacture of mifepristone and its distribution to the American market.
A week before the FDA approved the drug, nine U.S. senators urged Secretary Shalala to postpone the launch of RU-486 until more information was available on its origins.
Unsurprisingly, the HHS head did not listen to their concerns, and the FDA continued with the approval without the American public being made aware of who made mifepristone.
On October 12, 2000, two weeks after the approval went into effect, it was reported that Hua Lian, a Chinese pharmaceutical company, was making the mifepristone that was being prescribed to American women. This was particularly notable as the company had a reputation for developing notoriously substandard drugs and skirting FDA requirements.
In 2001, the Washington Examiner reported: “As recently as 1998, the California Health Department found not only that the company had illegally sent a shipment of drugs to America, but that it contained the unapproved drug fluorouracil. In July 2000 in Cincinnati, the FDA confiscated a shipment from Hua Lian’s factory ‘for false or misleading labeling and misbranding.’”
Unsafe, Convenient, and Commonplace
In the immediate aftermath of the FDA’s greenlighting of the abortion pill, House Majority Whip Tom DeLay pointed out that the strongarming by the Clintons represented a sharp departure from their often-repeated talking point of wanting to make abortion “safe, legal, and rare.” Instead, DeLay, then the third-ranking Republican in the U.S. House, stated that the Clintons were making abortions “convenient” and “unsafe.”
The next year, Hillary Clinton, now a newly-elected U.S. senator, questioned Tommy Thompson, President George W. Bush’s nominee to head the Department of Health and Human Services (HHS). The FDA operates under the authority of HHS. Clinton questioned Thompson specifically about his stance on the FDA’s approval of mifepristone. Thompson responded, “It’s a new drug, it’s contentious and controversial, and the safety of it, as I understand, is in question.”
Many echoed DeLay’s and Thompson’s concerns, pointing out the numerous safety questions surrounding mifepristone. However, as Baptist noted, the Clinton administration went to extreme lengths to make sure the drug went to and stayed in market:
Because, even then, the FDA recognized the inherent danger associated with these drugs. The FDA wanted to put some post-approval restrictions on the distribution of this drug, and appropriately so, but to do so, they had to use its fast-track approval authority. And that authority was very limited. Initially, it was intended for AIDs patients and cancer patients so they could receive life-saving and life-affirming drugs. Here, what the FDA had to do was call pregnancy an illness and then argue that chemical abortion drugs provide a meaningful therapeutic benefit for women and girls who take them.
Rolling Back Restrictions
Even after all of this, the FDA did away with the market restrictions it initially imposed on mifepristone. Much of this happened during the early years of the Bush presidency. Margot Cleveland of The Federalist reported:
In 2002, the FDA removed even more of the safety restrictions, increasing the maximum gestational age from seven-weeks gestation to 10-weeks gestation, reducing the number of office visits from three to one, increasing the drug dosage, allowing non-doctors to prescribe and administer chemical abortions, and eliminating the requirement for non-fatal adverse reactions to be reported.
This, according to Judicial Watch, was in direct violation of the FDA’s own testimony to Congress prior to authorizing chemical abortion drugs:
In a congressional hearing after the 2000 approval of Mifeprex, the FDA asserted that it chose to approve mifepristone [and] to maintain more stringent safety restrictions on the drug…. This included the requirement that the drug be administered “by or under the supervision of a physician” who met several qualifications.
In his April 7 ruling, Kacsmaryk touched on that sudden pivot by the government to greatly expand access to the abortion drug just less than two years after it had arrived on American shores:
Whether FDA abandoned its proposed restrictions because of political pressure or not, one thing is clear: the lack of restrictions resulted in many deaths and many more severe or life-threatening adverse reactions. Due to FDA’s lax reporting requirements, the exact number is not ascertainable.