FDA May Impose Rules on RU-486 Use, Planned Parenthood Warns

The government is considering rules for use of the abortion pill RU-486 that could restrict access to the early abortion option, Planned Parenthood’s director said Tuesday.

The Food and Drug Administration said in February that it would approve sale of RU-486, also known as mifepristone, once some final undisclosed requirements are met.

The pill’s sponsor, the nonprofit Population Council, told abortion providers last week that the FDA is proposing some curbs on the pill’s use, said Gloria Feldt, national president of Planned Parenthood.

“We are deeply concerned that FDA is considering restrictions that in my view would virtually assure that very few doctors would ever make mifepristone available,” Feldt said Tuesday.

She said the biggest concern is an FDA proposal that physicians allowed to administer RU-486 must be part of a registry, which she said would deter doctors worried about anti-abortion violence from offering the pill.

Feldt said the FDA is also considering long-term health tracking of at least some RU-486 recipients, something she called unnecessary because half a million European women have used the pill successfully since 1988.

FDA officials declined comment.