FDA considering restricted access to "abortion pill"

CMAJ 2000;163(5):586

"The whole point of this is to increase access for women and open [distribution] to different providers," says Sandra Waldman of the Population Council, the international nonprofit research institution that holds the drug's US patent.

Under the US Food and Drug Administration (FDA) proposal, only doctors trained to provide surgical abortions would be allowed to prescribe the drug and these doctors must have privileges at a hospital within 1 hour of their offices in case a blood transfusion is necessary (a rare occurence with mifepristone, according to the Population Council). Eligible doctors would be certified, and a confidential registry would be held by the drug's US distributor. The government agency rarely imposes such tight restrictions on a drug.

The FDA found mifepristone (RU-486) to be safe and effective in 1996, is discussing the distribution restrictions with the drug's distributor and the New York-based Population Council. Results from those discussions are expected at the end of September, when the application could be refused or extended for another 2 to 6 months.

But mifepristone has become a federal election issue, leading to fears that it may be delayed indefinitely. "If they don't get this approved before the [November] election and if the Republicans win, it will probably have a very difficult time getting approval," says Anne Burnett of the Planned Parenthood Federation of Canada.

"They are terrible restrictions," Burnett adds, "but I would like to see it get into the US under any circumstances." With US approval, she hopes the efficacy of the drug will be demonstrated and Canada won't impose the same restrictions. (The testing process here would likely take 2 to 3 years.)

Mifepristone has been available to women in many European countries for more than a decade. More than 500 000 women worldwide have used it, with few complications reported.

When taken with misoprostol, which has already been approved in Canada, mifepristone causes abortion — in essence a miscarriage — in 95% of women who are no more than 49 days pregnant.

Burnett says 50 million abortions take place worldwide each year, and many women die because they are done unsafely. "Getting this drug out there is so important," she says. — Barbara Sibbald, CMAJ

© 2000 Canadian Medical Association or its licensors