Sixteen years ago this week, the U.S. Food and Drug Administration approved mifepristone, sometimes referred to as RU-486, for early medication abortion. Hopes were high back then that the drug would revolutionize abortion access, taking the procedure out of clinics and moving it into the privacy of women’s homes. If every doctor in America – or at least every OB-GYN – could offer this option, women’s access to abortion would improve dramatically. Women might also avoid protesters at abortion clinics if they could just go to their regular doctor. Of course, things did not turn out this way. Few physicians who do not offer suction abortion provide mifepristone, so most women who want this method still have to go to an abortion clinic.

Healthcare providers who would like to become certified to prescribe Mifeprex must have the ability to date pregnancies accurately and to diagnose ectopic pregnancies. Healthcare providers must also be able to provide any necessary surgical intervention, or have made arrangements for others to provide for such care. Healthcare providers must be able to ensure that women have access to medical facilities for emergency care, and must agree to other responsibilities, including reviewing and signing the Patient Agreement Form with the patient and providing each patient with a copy of the signed Patient Agreement Form and the Medication Guide.

States limit access to medication abortion in a number of ways. In most states, only a physician can provide medication abortion, despite the evidence that this option can be safely provided by nurse practitioners, nurse midwives and physician assistants… Further, some states require physicians to follow the protocol described in the FDA-approved labeling of mifepristone that was, up until recently, out of date and not consistent with published evidence. For every other drug, doctors are allowed to use medications according to published evidence, even if this differs from protocols described in a drug’s label. This so-called off-label use of medications is quite common, especially in obstetrics and pediatrics… It is time for these dispensing restrictions on mifepristone to be removed. After 16 years of experience with medication abortion, it is clear that this option is very safe.

… [I]nformation on serious adverse reactions was reported in six U.S. and four non-U.S. clinical studies, totaling 30,966 women through 70 days gestation… Serious adverse reaction rates were similar between U.S. and non-U.S. studies, so rates from both U.S. and non-U.S. studies are presented.

After reviewing the data and information submitted by the drug company that markets Mifeprex, and after taking into consideration the safety data that have become available since the initial approval of Mifeprex in 2000, the FDA concluded that certain restrictions continue to be necessary to ensure the safe use of the drug.

My daughter Holly was a beautiful 18-year young woman. Unbeknownst to me until that fateful day, Planned Parenthood prescribed my daughter an unapproved/off-label mifepristone (commonly known as RU-486, U.S. trade name Mifeprex, The Abortion Pill) and misoprostol medical abortion drug regimen. I first learned of it when I received a call from the hospital stating that she was there and in serious condition. Later that day, while at her bedside, my daughter tragically died from an infection known as Clostridium sordellii toxic shock syndrome that was associated with a medically induced abortion…. At the clinic, Holly was administered an un-approved (off-label/modified/alternative/evidence-based) regimen of 200-mg mifepristone orally which blocks the hormone progesterone that is required to maintain a pregnancy. At home, 24 hours later, on September 11, she followed the clinic’s off-label instructions to vaginally insert 800-mcg of misoprostol to induce labor contractions and expel the fetus. On September 13, Holly repeatedly called the Planned Parenthood clinic hotline to complain of severe cramping. She was told her symptoms were normal and to take the clinic prescribed Tylenol-Codeine painkiller. Later, Holly called the clinic’s hotline again and was told to go to a local hospital’s emergency room if the pain continued. By September 14, Holly was still experiencing extreme cramping and bleeding, and visited the emergency room of Valley Care Medical Center in Pleasanton on the fourth day after her initial visit to Planned Parenthood. The doctor there, whom she told about her abortion, sent her home after an injection of narcotics and yet more painkillers. The severity of the pain continued. Holly was weak, vomiting, and unable to walk. In the early morning hours of September 17, 2003, she was re-admitted to Valley Care Medical Center. Holly died on the seventh day after starting the mifepristone/misoprostol medical abortion regimen. This was the same day she was scheduled to return to Planned Parenthood for a follow up visit to make sure her abortion had been completed.

Sixteen years ago this week, the U.S. Food and Drug Administration approved mifepristone, sometimes referred to as RU-486, for early medication abortion. Hopes were high back then that the drug would revolutionize abortion access, taking the procedure out of clinics and moving it into the privacy of women’s homes. If every doctor in America – or at least every OB-GYN – could offer this option, women’s access to abortion would improve dramatically. Women might also avoid protesters at abortion clinics if they could just go to their regular doctor. Of course, things did not turn out this way. Few physicians who do not offer suction abortion provide mifepristone, so most women who want this method still have to go to an abortion clinic.

Healthcare providers who would like to become certified to prescribe Mifeprex must have the ability to date pregnancies accurately and to diagnose ectopic pregnancies. Healthcare providers must also be able to provide any necessary surgical intervention, or have made arrangements for others to provide for such care. Healthcare providers must be able to ensure that women have access to medical facilities for emergency care, and must agree to other responsibilities, including reviewing and signing the Patient Agreement Form with the patient and providing each patient with a copy of the signed Patient Agreement Form and the Medication Guide.

States limit access to medication abortion in a number of ways. In most states, only a physician can provide medication abortion, despite the evidence that this option can be safely provided by nurse practitioners, nurse midwives and physician assistants… Further, some states require physicians to follow the protocol described in the FDA-approved labeling of mifepristone that was, up until recently, out of date and not consistent with published evidence. For every other drug, doctors are allowed to use medications according to published evidence, even if this differs from protocols described in a drug’s label. This so-called off-label use of medications is quite common, especially in obstetrics and pediatrics… It is time for these dispensing restrictions on mifepristone to be removed. After 16 years of experience with medication abortion, it is clear that this option is very safe.

… [I]nformation on serious adverse reactions was reported in six U.S. and four non-U.S. clinical studies, totaling 30,966 women through 70 days gestation… Serious adverse reaction rates were similar between U.S. and non-U.S. studies, so rates from both U.S. and non-U.S. studies are presented.

After reviewing the data and information submitted by the drug company that markets Mifeprex, and after taking into consideration the safety data that have become available since the initial approval of Mifeprex in 2000, the FDA concluded that certain restrictions continue to be necessary to ensure the safe use of the drug.

My daughter Holly was a beautiful 18-year young woman. Unbeknownst to me until that fateful day, Planned Parenthood prescribed my daughter an unapproved/off-label mifepristone (commonly known as RU-486, U.S. trade name Mifeprex, The Abortion Pill) and misoprostol medical abortion drug regimen. I first learned of it when I received a call from the hospital stating that she was there and in serious condition. Later that day, while at her bedside, my daughter tragically died from an infection known as Clostridium sordellii toxic shock syndrome that was associated with a medically induced abortion…. At the clinic, Holly was administered an un-approved (off-label/modified/alternative/evidence-based) regimen of 200-mg mifepristone orally which blocks the hormone progesterone that is required to maintain a pregnancy. At home, 24 hours later, on September 11, she followed the clinic’s off-label instructions to vaginally insert 800-mcg of misoprostol to induce labor contractions and expel the fetus. On September 13, Holly repeatedly called the Planned Parenthood clinic hotline to complain of severe cramping. She was told her symptoms were normal and to take the clinic prescribed Tylenol-Codeine painkiller. Later, Holly called the clinic’s hotline again and was told to go to a local hospital’s emergency room if the pain continued. By September 14, Holly was still experiencing extreme cramping and bleeding, and visited the emergency room of Valley Care Medical Center in Pleasanton on the fourth day after her initial visit to Planned Parenthood. The doctor there, whom she told about her abortion, sent her home after an injection of narcotics and yet more painkillers. The severity of the pain continued. Holly was weak, vomiting, and unable to walk. In the early morning hours of September 17, 2003, she was re-admitted to Valley Care Medical Center. Holly died on the seventh day after starting the mifepristone/misoprostol medical abortion regimen. This was the same day she was scheduled to return to Planned Parenthood for a follow up visit to make sure her abortion had been completed.