The abortion pill was an amazing discovery that eventually gave women a new power over their reproductive systems. But the path between its discovery and widespread access to RU-486 (the abortion pill) spanned two decades.
For those 20 years, bitter contempt surrounded the drug. Advocates for RU-486 touted the drugs medical and societal uses, including the reproductive rights it would afford women. Its critics included anyone against abortion.
Despite the outrage, and even violence, displayed by pro-life critics, medical abortions with RU-486 became an option for American women on September 28th, 2000.
“A combination of complex business and political issues contributed to the long time it has taken to bring this product to the market,” said Sandra Waldman, the spokesperson for the Population Council in 2000.
“I think [the abortion pill] offers more options to women, but it won’t solve all of our abortion access problems. There are still issues to overcome, including whether or not insurance will cover the cost of abortion with RU-486, whether RU-486 can be administered by non-physician providers, and how doctors will accommodate the [time] that it takes to expel the fetus,” Tina Hoff, the director of Public Health Information & Communication at the Henry J. Kaiser Family Foundation, told WebMD, following FDA approval for the drug.
And both Sandra Waldman, and Tina Hoff, were right – we’ve come a long way, but we still have a long way to go.
Where Did it All Start?
April of 1980 saw the discovery of the drug mifepristone (ex-RU486). The drug discovery was quickly considered a brilliant achievement, made by a massive research program conducted on steroidal compounds with antihormone properties. The research program itself was done at Roussel Uclaf, a French pharmaceutical company, in partnership with the INSERM unit of Pr. E. E. Baulieu.
In October 1981, an endocrinologist by the name of Étienne-Émile Baulieu, a consultant to Roussel-Uclaf, arranged tests of the drugs’ use for medical abortion in 11 women in Switzerland. Successful results were announced on April 19, 1982, but the FDA didn’t issue a testing permit until 1983. The Population Council, a nonprofit group, was the first in the US to conduct trials of mifepristone as an early abortion method.
After that, the political tension surrounding mifepristone began to rise at an alarming rate.
In 1988, RU-486 was approved in France, but its distribution came to a complete halt in response to anti-abortion protests. It wasn’t until the French Minister of Health intervened and ordered the company to return the drug to the market that production was reinstated. Even then, anti-abortion rights groups threatened to boycott Hoechst A.G. (Rousell-Uclaf’s parent company).
Between 1994 and 1995, after significant political battles were fought in favor of the drug, Roussel-Uclaf gave the Population Council the US patent rights for RU-486, and clinical trials, involving 2,100 women, began.
The Population Council submitted a drug application to the FDA for mifepristone as an early abortion method in March of ’96. This was followed, in July, by an advisory arm of the FDA recommending RU-486 for approval, deeming it a “safe and effective” nonsurgical early abortion method.
RU-486 was on track to hit the market in the US until February 1997, when it hit a significant roadblock. The European manufacturer that was responsible for producing RU-486 in the US canceled its contract with the Population Council – effectively delaying the drug’s introduction in the US.
This was followed in June of 1998, by the US government banning the FDA from using government funds to test, develop, or approve any abortion drug. The Clinton Administration, however, opposed the ban, and in October of ’98, the ban was removed.
It wasn’t until September 28th of 2000 that RU-486 saw the end of its long and intense battle, finally being approved by the FDA.
Even after approval by the FDA, many anti-abortion groups continued (and still continue) to lobby against it – aiming to have it removed from the market. And even though it’s been approved by the FDA, RU-486 still isn’t readily available to the public. Getting a medical abortion using RU-486 requires specially qualified and licensed physicians.
FDA approval was a big step toward effective family planning and reproductive freedom for women. However, we’re still a long way from making medical abortions, using drugs or any other method, available internationally. And we’re even further from ending the stigma surrounding medical abortion.
But progress is progress.