Sept. 28, 2000 -- The road toward FDA approval for the abortion pill RU-486, or mifepristone, has spanned two decades and been cluttered with at-times bitter, contentious battles between those against abortion rights and pro-choice advocates. But as of Thursday, medical abortion with RU-486 is now an option for American women.
To date, more than half a million women in Europe have undergone medical abortions with RU-486, as have thousands of women in the U.S. as part of clinical trials.
"A combination of complex business and political issues contributed to the long time it has taken to bring this product to the market," says Sandra Waldman, spokesperson for the Population Council, a nonprofit group marketing the drug in the U.S.
"I think RU-486 offers more options to women, but it won't solve all of our abortion access problems," says Tina Hoff, director of Public Health Information and Communication at the Henry J. Kaiser Family Foundation in Menlo Park, Calif. "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," she tells WebMD.
To illustrate the long, embattled road toward approval, WebMD has put together a time line of the milestones and roadblocks in the fight to approve RU-486, both here and abroad:
- 1980 -- Researchers at Roussel-Uclaf, a French pharmaceutical company, develop mifepristone (RU-486).
- 1983 -- The FDA issues a testing permit to the Population Council, a nonprofit group, to conduct trials of mifepristone as an early abortion method.
- 1988 -- RU-486 is approved in France, but distribution is halted in response to protests. The French Minister of Health intervenes and orders the company to return the drug to the market. Anti-abortion rights groups then threaten to boycott Hoechst A.G. (Rousell-Uclaf's parent company).
- 1989 -- In response to pressure from the Bush Administration and others, the FDA bans the importation of RU-486 for personal use. Hoechst says it won't market or distribute the drug outside of France to appease groups against abortion rights.
- 1990 -- Leading scientists testify before Congress that the FDA import ban has hindered research on the broad medical benefits of RU-486, including treatment for some cancers, HIV, and uterine tumors, and for inducing labor.
- July 1992 -- An American woman named Leona Benten issues the first direct challenge to the FDA import ban when U.S. Customs seizes the drug from her as she returns from Europe. However the U.S. Supreme Court refuses to hear her case or order the FDA to overturn the ban.
- Jan. 1993 -- President Clinton asks the FDA to re-examine its import ban.
- Sept. 1993 -- The Institute of Medicine suggests that an expedited new drug application be submitted to the FDA for the use of RU-486 as a method of early abortion.
- 1994-1995 -- Roussel-Uclaf gives the Population Council the U.S. patent rights for RU-486. Clinical trials involving 2,100 women begin.
- March 1996 -- The Population Council submits a drug application to the FDA for RU-486 as an early abortion method.
- July 1996 -- An advisory arm of the FDA recommends approval of RU-486 as a safe and effective early nonsurgical method of abortion.
- Sept. 1996 -- The FDA issues an "approvable letter" for RU-486 for early abortion, when used with misoprostol, a drug that causes uterine contractions to expel the embryo. The letter states that the two-drug combination is safe and effective when used under close medical supervision but notes that additional information is needed on the manufacturing process and labeling before a final decision is made.
- Feb. 1997 -- A major roadblock: The European manufacturer responsible for producing RU-486 in the U.S. cancels its contract with the Population Council -- delaying the drug's introduction in the U.S. indefinitely.
- April 1997 -- A study in The New England Journal of Medicine shows that RU-486, when used in combination with a type of drug called a prostaglandin (misoprostol), medically terminates 92% of pregnancies when taken within 49 days of conception.
- June 1998 -- An amendment to a bill is passed that bans the FDA from using funds to test, develop, or approve any abortion drug.
- Sept. 1998 -- The Clinton administration opposes the amendment.
- Oct. 1998 -- The ban is deleted from the bill.
- Feb. 2000 -- The FDA postpones approval of RU-486 until certain questions about the manufacturing and distribution of the drug are answered.
- Sept. 28, 2000 -- RU-486 is approved by FDA as a method of early medical abortion.