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The FDA just made the abortion pill easier to get The FDA just made the abortion pill easier to get
(about 7 hours later)
New recommendations for the abortion pill announced Wednesday by the Food and Drug Administration could increase use of the medication to terminate a pregnancy in the United States. The Food and Drug Administration has changed its guidelines for use of the abortion pill, potentially increasing access to a method of pregnancy termination that has been heavily restricted in some states.
The new label changes the recommended dosage of the two drugs used in the abortion process. It allows the treatment to be used up to 70 days into pregnancy — three weeks longer than the previous guidelines. It also relaxes prescriber guidelines to allow, for example, a nurse practitioner to administer the drugs. The changes bring the guidelines in line with what many doctors consider standard practice. They also undercut one strategy that had been used by antiabortion activists to reduce access to medication-induced abortion, which women are increasingly using as an alternative to the surgical procedure.
The reality in practice will not change for most abortion patients, as doctors for years have been legally diverging from the old FDA protocol based on new research. But a handful of states, including Texas and Ohio, have laws requiring abortion providers to adhere at least in part to the FDA-approved label, leading some providers there to all but abandon the use of the abortion pill. The new label lowers the recommended dosage of one of the two drugs used in medication abortions and allows the treatment to be used up to 70 days into pregnancy — three weeks longer than the previous guidelines. It also relaxes prescriber guidelines to allow, for example, a nurse practitioner to administer the drugs.
“The label change for medication abortion will mean that it will once again be a real option for Preterm’s patients and women across the state,” Chrisse France, executive director of Preterm, an abortion provider in Ohio, said in a statement. “We will no longer be forced to practice medicine mandated by politicians whose ultimate goal is to shut us down.” In practice, the situation will not change for most of those seeking abortions, as doctors for years have been diverging from the old FDA protocol on the basis of new research — a common practice known as prescribing a drug “off-label.”
Antiabortion groups noted that the new label carries over the old label’s warnings of some of the dangers associated with the drug — including the very rare possibility of infection or death. But a handful of states have laws requiring abortion providers to adhere at least in part to the FDA-approved label, leading some providers to all but abandon the use of the abortion pill.
“The label change for medication abortion will mean that it will once again be a real option for Preterm’s patients and women across the state,” said Chrisse France, executive director of Preterm, the largest abortion clinic in Ohio. “We will no longer be forced to practice medicine mandated by politicians whose ultimate goal is to shut us down.”
In 2011, when Ohio passed a law requiring clinics to adhere to the FDA protocol, requests for medication abortions at Preterm plummeted from about 13 percent of patients to fewer than 2 percent, France said in a teleconference Wednesday with reporters. Reverting to the old protocol made abortions costlier and required four visits to the clinic, France said. Surgical abortions in Ohio typically require only two visits, she said.
Texas and North Dakota also have laws requiring abortion providers to follow FDA guidelines, according to the Guttmacher Institute, which studies reproductive rights issues. Arizona and Arkansas passed such laws, but they have been temporarily blocked by the courts.
Groups said the new label guidelines could lead to more medication abortions nationally. More doctors may be persuaded to allow the use of the abortion pill later in pregnancy than they had previously been inclined to do, they said, and more nurse practitioners could be empowered to administer the drugs. Medication abortions accounted for nearly 1 in 4 nonhospital abortions in 2011, the latest year for which figures are available, according to Guttmacher.
Mark S. DeFrancesco, president of the American Congress of Obstetricians and Gynecologists, issued a statement Wednesday saying that he was “pleased that the updated FDA-approved regimen for mifepristone reflects the current available scientific evidence and best practices.”
Antiabortion groups noted that the new label carries over the old label’s warnings — including the rare possibility of infection or death.
“The new label affirms the deadly realities of chemical abortion and underscores the need for in-person patient examination and follow-up care as well as the fact that the abortion drug regimen presents serious risks to women’s health,” Anna Paprocki, staff attorney for Americans United for Life, said in a statement.“The new label affirms the deadly realities of chemical abortion and underscores the need for in-person patient examination and follow-up care as well as the fact that the abortion drug regimen presents serious risks to women’s health,” Anna Paprocki, staff attorney for Americans United for Life, said in a statement.
The label change is effective immediately. It applies to Mifeprex, which is the brand name for mifepristone, one of the two drugs used in medication abortions. It blocks the production of progesterone, a hormone that prepares the lining of the uterus for a fertilized egg. A day or two after taking that drug, the woman takes the second drug, misoprostol, which causes the uterus to contract and expel the pregnancy. The label change, effective immediately, applies to Mifeprex, the brand name for mifepristone, the costlier of the two drugs used. It blocks the production of progesterone, a hormone that prepares the lining of the uterus for a fertilized egg. A day or two after taking that drug, the woman takes the second drug, misoprostol, which causes the uterus to contract and expel the pregnancy.
The FDA said that the manufacturer of Mifeprex, Danco Laboratories, applied for the updated label as part of a “supplemental new drug application” submitted to the agency in late May. The company proposed that the treatment be used to end a pregnancy through the first 70 days of gestation — that’s 70 days from the first day of the woman’s last menstrual period. Under the original labeling, the treatment was to be used only through the first 49 days of gestation. Most clinics price surgical and medication abortions similarly, said Vicki Saporta, president of the National Abortion Federation, a trade group for abortion providers, so a reduction in the Mifeprex dosage may reduce the overall cost of the procedure.
The agency also approved changes in the doses of the drugs and the dosing regimen. Under the old regimen, a woman would take three Mifeprex tablets on the first day and two misoprostol tablets on the follow-up day. Under the new label, a patient would take one Mifeprex tablet on the first day and four misoprostol tablets 24 to 48 hours later. Under the revised label, women are advised to return to their health-care providers a week or two after taking Mifeprex. That recommendation was two weeks under the old label. The FDA declined to make any officials available for interviews, saying it did not want to identify individuals involved in the Mifeprex decision because of concerns they might be targeted for harm by people opposed to the use of the abortion pill.
The FDA initially approved Mifeprex in September 2000, and women can get it from their health-care providers such as clinics, medical offices and hospitals, and under the supervision of a certified prescriber. It is not available in retail pharmacies or legally sold over the Internet.
The agency said that cramping and vaginal bleeding are possible side effects of the treatment and that in some cases surgery will be needed to stop very heavy vaginal bleeding. Other potential side effects, the FDA said, include headache, diarrhea, dizziness and vomiting.