On September 28, the Food and Drug Administration approved RU-486, also known as the abortion pill. The drug is one of the most controversial ever to pass through the agency's regulatory process. In 1996, the FDA declared RU-486 "safe and effective" but did not approve the drug at that time. While news that the FDA was moving closer to approval was cheered by reproductive rights advocates, many expressed concern over the proposed restrictions. Under the FDA's proposed rules, only physicians with admitting privileges at a hospital would be permitted to administer RU-486, and only doctors trained in surgical abortions would be permitted to prescribe the drug. In addition, those doctors who opted to prescribe the drug would be listed on a national registry. Some advocates of RU-486 object to the proposed rules, arguing that doctors would be reluctant to be listed on a public registry, for fear of attracting anti-abortion violence.

RU-486, or Mifepristone-Misoprostol is an "abortifacient" that prevents an impregnated embryo from receiving the hormone progesterone, which is essential for further fetus development. A chemical abortion occurs within 48 hours after the drug is administered.

RU-486 is only effective during the first seven weeks of pregnancy, and requires at least three medical visits. In 5 percent to 10 percent of the cases, the drug does not induce a complete abortion and must be followed by a surgical procedure.

RU-485 is legal and widely used in many parts of Europe, but pressure from anti-abortion groups has delayed the drug's approval in the United States. Pending FDA approval, the drug is only available in a limited number of clinical trials.

On One Hand...

FDA's recent approval of RU-486 will reduce the number of surgical abortion procedures. Since the majority of abortion facilities are located in urban areas, legalizing RU-486 gives women living outside of cities greater access to abortions in their local communities.

Studies indicate that RU-486 may also be effective in treating medical problems, such as fibroid tumors.

On the Other Hand...

Although nearly all physicians will be able to administer RU-486, too few doctors have the necessary training to perform surgical abortions for the 5 percent to 10 percent of women for whom the drug is ineffective. This could lead to serious medical problems.

Administering RU-486 involves several hours of medical observation abd will increase medical costs due to increases in medical staff, billing hours and inevitable malpractice suits.

• The Centers for Disease Control and Prevention estimates that there were 1,184,758 legal abortions in 1997.

• An American Pharmaceutical Association survey of 400 pharmacists found that 59.6 percent of respondents would refuse to dispense RU-486 for abortion purposes if legal.

• In an FDA-sanctioned study involving over two thousand pregnant women who were administered RU-486, 76.9 percent of those who had prior surgical abortion procedures found their RU-486 experience "more satisfactory."

• On average, one woman dies from an abortion procedure for every 150,000 successful abortions.

• According to the National Abortion Federation, "84 percent of all U.S. counties have no identifiable abortion provider."

American Medical Association, U.S. Food and Drug Administration, The Associated Press, American Pharmaceutical Association