The abortion pill had already acquired a troubling history in France before anyone tried to foist it on American women.
It had been approved, pulled from the market, and forced back onto the market by government officials. Serious bleeding and other complications had already been documented. The science was anything but “settled.”
None of that stopped—or even slowed down—the campaign to bring RU-486 to the United States.
If anything, it made its promoters more anxious to quickly bring the pill across the Atlantic.
America was supposed to be off-limits
Roussel-Uclaf, the French company that developed RU-486, originally had little interest in bringing the deadly drug to the United States.
The reason wasn’t difficult to understand. Opposition to abortion ran deep in American society, and politically influential pro-life organizations were already pressuring the federal government to keep the drug out.
The Reagan administration blocked efforts to introduce RU-486 into the country and, in 1989, the FDA went even further. It prohibited individuals from importing the drug, effectively closing off the American market.
For the time being, the abortion pill was staying in France.
Then a pro-abortion Democrat named Bill Clinton took office.
The White House pushes the pill
Clinton had campaigned on a promise to make abortion “safe, legal and rare.” But that turned out to be mere campaign rhetoric. As soon as he took office in 1993, he directed the Department of Health and Human Services and the FDA to lift the import ban on RU-486.
But Clinton, not content to sit back and wait for the drug to make its way to the American market, went even further. The American president personally pressured Roussel-Uclaf executives to hand over the rights to the drug to an American organization, given that they were reluctant to market it in America themselves.
The Roussel-Uclaf executives ultimately agreed to cede their rights, but it turned out that American pharmaceutical companies were leery of promoting an abortion pill as well. The rights to produce and market the drug in the U.S. were ultimately given to the Population Council.
The Population Council is the farthest thing from a pharmaceutical company. Founded in 1952 with funding from population-control enthusiast John D. Rockefeller III, it had spent decades driving down birthrates in developing countries. It had done so by promoting contraception, sterilization and abortion campaigns in dozens of countries.
Now it would hold the U.S. rights to a drug whose sole purpose was to end the lives of unborn American children.
In May 1994, the company transferred the American patent rights to the Population Council. It asked for nothing in return.
The way had finally been cleared for RU-486 to enter the American market.
A nonprofit, a secretive company, and a drug made overseas
The Population Council conducted clinical trials of RU-486 between September 1994 and September 1995. Then it licensed the drug to a newly created company called Danco Laboratories.
Danco was created for one purpose and one purpose only: to market mifepristone to Americans. The manufacture of the drug would be outsourced to a Hungarian company. The names of its investors were kept hidden, but they were widely understood to be wealthy individuals and foundations that supported abortion rights.
Citing security concerns, Danco would not even reveal the names of its executives or the location of the company’s headquarters.
The level of secrecy was more suited to a clandestine CIA operation than a pharmaceutical company.
But then, Danco wasn’t really a pharmaceutical company at all. It was a vehicle for getting the abortion pill into the hands of as many American women as possible.
The approval process dragged on
Danco submitted its application to the FDA in March 1996. By September, the FDA had determined that the drug could potentially be approved, but additional information was still required, particularly concerning manufacturing and labeling.
Then the manufacturing arrangement fell apart as Danco’s original manufacturer backed out. Finding another manufacturer and reworking its way through the FDA approval process took years.
It wasn’t until September 28, 2000, that the FDA approved RU-486 under its new brand name: Mifeprex.
Despite support from the White House, the FDA’s approval process had taken six years—even though they cheated.
The shortcut to approval
Mifeprex wasn’t approved in the ordinary way. Instead, the FDA tried to slip it in under something called “Subpart H”. This is an accelerated approval pathway that is only supposed to be used for drugs developed to treat serious or life-threatening illnesses or conditions.
When patients are dying, you want promising new drugs to reach them more quickly. But pregnancy is not a fatal disease.
Nor could abortion advocates claim that chemical abortion was the only treatment available for an unwanted pregnancy, since under Roe v. Wade surgical abortion was widely available.
A lawsuit was quickly filed challenging the drug’s approval. Pro-lifers charged that the FDA had improperly applied Subpart H.
Mifepristone had not been developed to treat serious or life-threatening illnesses, but rather to allow healthy moms to end normal pregnancies.
The FDA, under pressure from the Clinton White House, had broken its own rules in approving it.
Patient protections eroded away
When the FDA approved mifepristone in 2000, it put up guardrails against its abuse.
The drug could only be prescribed by specially qualified physicians, and its use was limited to pregnancies up to seven weeks. Three in-person visits were required, and the approved dose was higher.
Those guardrails didn’t last. Over the years, the FDA took down one after another.
- The pill could be used later in pregnancy.
- The number of required in-person visits was reduced.
- The dosage was reduced.
Eventually, under pressure from the Biden administration, the FDA did away with the requirement for an in-person examination, and even permitted the pill to be dispensed through the mail.
Each change made the abortion pill easier to obtain. Women were now using the drug under vastly different circumstances than those under which it had originally been approved.
Questions about the drug’s safety didn’t disappear simply because the guardrails did. They intensified.
The fight isn’t over
The approval of mifepristone in 2000 was supposed to settle, once and for all, the question of whether the drug belonged on the American market.
It didn’t.
The original approval has since become the subject of federal litigation challenging the FDA’s actions, including its use of the accelerated approval pathway and later changes to the drug’s prescribing and dispensing requirements.
At the same time, concerns about the drug’s safety have continued to fuel demands for a closer examination of the evidence behind those regulatory decisions.
The Trump administration has ordered a review of mifepristone’s safety, with Health and Human Services Secretary Robert F. Kennedy Jr. overseeing the department responsible for that review.
That review matters.
Because the history of RU-486 in America is not simply a story about a new pharmaceutical product making its way through the normal regulatory process.
It is the story of a drug that a major French pharmaceutical company was reluctant to bring here, a White House that intervened to help get it here, a population-control organization that acquired the American rights, a newly created company that took over its distribution, and an approval that was granted through a controversial regulatory pathway.
Throughout the process, we keep coming back to the same question:
What happens when political pressure to expand abortion access moves faster than the evidence needed to protect women?
France had already shown us what could happen.
America chose to bring the drug here anyway.
And the consequences have been measured not only in regulatory battles and courtroom arguments, but in women who have experienced hemorrhage, infection, emergency treatment, and other serious complications, even death—and in the millions of unborn children whose lives have been ended by the drug.
The story of RU-486 in America was never simply about giving women another choice.
It was about getting a controversial abortion drug into the American market, then making it ever easier to obtain.
The fight over removing the deadly drug from the market is far from over.
