Early Abortion Pill Approved by FDA
FDA is limiting the physicians who may prescribe Mifeprex. The agency says that doctors who prescribe the drug must be able to date pregnancies accurately. They must also be able to diagnose tubal pregnancies, since women with tubal pregnancies may not take the drug.
FDA also requires that physicians be prepared to provide women any necessary surgery, or arrange for those procedures in the case of incomplete abortion or severe bleeding. Doctors also must ensure that women who take the drug have access to emergency care.
The agency first issued an "approvable" letter for the drug in 1996, which indicated that most -- but not all -- conditions for approval had been met.
But since then, the drug has had a tough time finding its way to market. Congress has repeatedly tried to block FDA's review of the drug, even as ownership of the rights to the medication changed hands. In 1989, the Bush Administration had banned Americans from importing RU-486 for personal use, a ban that Clinton lifted in 1993.
"Today's action by the FDA assures that women across the country will be able to make informed choices about the use of this drug -- choices based on solid scientific evidence," said Richard G. Roberts, MD, president of the American Academy of Family Physicians.
But anti-abortion advocates dread the potential impact of the approval. "The FDA's approval of RU-486 could result in more abortions and, therefore, more dead babies and injured women," Teresa Wagner, a legal analyst at the Family Research Council, said. "It's not only unprecedented for the FDA to approve a drug that has no therapeutic effects, but it's unethical."
The FDA has posted information about Mifeprex at www.fda.gov/cder/drug/infopage/mifepristone/default.htm.