NEW YORK (Reuters) -- The Food and Drug Administration (FDA) announced Wednesday that it is prepared to approve the abortion pill RU-486. But the agency says it needs additional manufacturing and labeling information before the decision is final.
RU-486 provides a drug-induced, non-surgical abortion to women via a combination of pills. The pills are taken early in pregnancy, usually between the 5th and 7th weeks, in the privacy of a doctor's office.
A letter from the FDA to the non-profit group Population Council, which owns the U.S. rights to RU-486, states that the combination of drugs demonstrates "safety and efficacy," and recommends that use should occur "under close medical supervision."
But the agency requests further information on manufacturing and labeling of the drug before final approval. The FDA panel is also concerned that doctors be properly trained in administering the combination of drugs.
RU-486 can cause heavy bleeding. Opponents of the drug have cited this as a major concern.
But abortion advocacy groups say the drug could "remake the abortion landscape" in the nation by making abortions easier, and making the procedure a private matter between a woman and her doctor.
"It will increase access to abortion dramatically," says Ellie Smeal, president of the Feminist Majority. And since RU-486 moves abortion away from high-profile clinics and into doctors' offices, she believes "it will help reduce clinic violence. [Protesters] won't even know where the sites are."
RU-486, or mifepristone, terminates pregnancy by blocking the action of the hormone progesterone. In trials of more than 2,000 women in France, it induced abortion successfully 95% of the time. The drug is given along with another compound, a prostaglandin, which helps expel the embryo.
"We are sure we will be available to provide the FDA the outstanding information necessary for approval," said a statement issued by the Population Council in response to the FDA.
FDA review of the drug comes in the middle of President Clinton's re-election campaign. The President has gone on record in support of approval for RU-486.
Right-to-life activists have accused the Clinton administration of trying to speed up the approval process so that it can occur before the November election.
RU-486 is manufactured by the European company Roussell Uclaf, who markets the drug in England, Sweden, and China.
With President Clinton's encouragement, Roussell Uclaf donated the patent rights for mifepristone to the New York-based Population Council. Hoechst AG, the German parent-company of Roussell Uclaf, feared violent reprisals or boycotts and transferred the U.S. approval sponsorship to the non-profit group.
If RU-486 receives final FDA approval in the U.S., its manufacturer would probably remain anonymous. Its distributor will be the non-profit group, Advances in Health Technology.
