by Jennifer Jackman

Six months after receiving a New Drug Application to license mifepristone (formerly known as RU 486) for distribution in the United States, the Food and Drug Administration issued a letter to the Population Council stating that this medical method of early abortion is safe and effective and that the drug is ‘approvable’ pending additional information. The FDA’s action makes mifepristone availability in the U.S. likely in 1997.

"This announcement marks a milestone in making mifepristone available to American women," said Eleanor Smeal, President, Feminist Majority Foundation, "and in assuring the conduct of desperately needed research on the non-abortion indications of this life-saving medication. The FDA has put science ahead of politics."

Smeal added, "The FDA’s action represents a hard-won victory for the U.S. feminist movement, for the scientific and medical community, and, most importantly, for the women of this nation. The continued vigilance of pro-choice organizations is necessary to assure that final FDA approval will come quickly."

The Population Council submitted its New Drug Application on March 18, 1996, after receiving U.S. patent rights to the drug from the French pharmaceutical company Roussel Uclaf in 1997. The FDA’s Reproductive Health Drug Advisory Committee on July 19, 1996 recommended FDA approval of mifepristone.

The FDA’s ‘approvable’ rating is frequently the next step in the approval process. According to the Population Council, additional information on labeling and the manufacturing process is necessary to complete the application. The Population Council anticipates that final approval for the compound will be forthcoming in 1997.

The Population Council is seeking FDA approval for the use of mifepristone in conjunction with misoprostol, a prostaglandin which is already on the U.S. market, to terminate pregnancy up to 49 days.

The Population Council has licensed Advances in Health Technology, a non-profit organization headed by Dr. Susan Allen to arrange for distribution, manufacture, and development of mifepristone. "We are looking forward to implementing our training programs to prepare health care providers for the drug’s introduction," said Allen.

As a part of an eight year campaign to bring mifepristone to the U.S., the Feminist Majority Foundation delivered over 700,000 petitions to Roussel Uclaf and Hoechst AG urging release of the compound. The Foundation organized meetings between the European pharmaceutical firms and delegations of feminist leaders and prominent scientists, and won support for mifepristone from every major women’s rights organization and medical and scientific association.

For a history of the fight to bring mifepristone to the United States, see our Web site: .