Many pro-life individuals wear the tiny feet pins, representing the size of a child’s feet at ten weeks gestation. Today the FDA has announced a policy change that will expand the use of the abortion pill in Ohio to 70 days gestation – the same age as is represented by those tiny feet pins.
Generally, the change will have the most dramatic effect in Ohio, where a state law passed in 2004 (and then litigated until 2012) required that it be administered and prescribed exactly per the FDA label. Planned Parenthood vigorously argued for off-label use in Ohio, which is how it uses the drug in most states. In 2011, the FDA released a post-marketing report that RU-486 was responsible for at least 14 maternal deaths and more than 2200 serious complications in the US and at least 5 deaths outside of the US. Nationally, the abortion pill accounts for about 20-25% of all abortions. Here in Ohio, all medical abortions combined are about 5%.
By our reading, there will be three changes which will most dramatically impact Ohioans. The first is that the gestation stage at which the drug is used will be almost doubled. Previously, it was legal to use the drug up to 49 days gestation. The new label, effective today, will permit it to be used to 70 days gestation - 10 weeks. Secondly, it will reduce the requirement that each dose of the drug be administered by a physician. Currently each dose must be taken in clinic (some have questioned if this is the actual practice in some clinics). Now, the first dose will be administered in office but the second dose will be taken at home or "at a place convenient" to the woman. The third change will lower the dosing requirements.
The 2016 standards, announced by the FDA today, state:
Mifeprex is approved, in a regimen with misoprostol, to end a pregnancy through 70 days gestation (70 days or less since the first day of a woman’s last menstrual period). The approved Mifeprex dosing regimen is:
In addition to the complications noted above, Greater Columbus Right to Life has documented numerous botched abortions in women who were prescribed the RU-486 regimen locally in recent years. We will continue to monitor the available reports.
Today’s decision will undoubtedly have abortion advocates cheering that medical abortions will be available to more women, later in their pregnancies, with fewer visits to a doctor, and at a lesser cost. We cannot cheer. Despite the relatively low number of medical abortions in our state, they make up a large part of the documented complications from abortion. Intentionally expanding the availability and use of the abortion drug will increase the deaths of unborn children and put more women in physical danger. That the FDA amended this drug label despite its own documented adverse affects is unconscionable and suggests that this is a political decision made at the request of the abortion industry.
Abortion shows a fundamental disregard for the dignity of human life. It is a horrific and barbarous practice regardless of how it is performed or at what stage the child’s humanity is taken. Today’s move by the FDA is a step in the wrong direction. We will update you as additional information is made available, including information on how state regulatory entities respond.
Note: RU-486 works by blocking progesterone in the body. Without progesterone, a pregnancy cannot continue. For this reason, some people compare the abortion pill to intentionally inducing a miscarriage. In Ohio, the abortion pill has traditionally been regulated in the same manner as a surgical abortion, although recent policy changes have resulted in several new "pill mills" being opened outside of an ambulatory surgical facility environment. Medical abortions are different than so-called emergency contraception, which works in the same way that most hormonal birth control pills work. Many people are confused by the distinction between the abortion pill, which intentionally ends an established pregnancy, and the “morning after” (also called “Plan B”) pill, which can act as an abortifacient by preventing the implantation of a recently fertilized ovum. Here is a fact sheet from the Association of Reproductive Health Officials that offers an explanation of the difference. We provide this as an explanation, not as an endorsement. GCRTL policy opposes all abortifacients.
Note 2: This entry will be updated for content at our discretion. Any changes are to increase clarity.
Generally, the change will have the most dramatic effect in Ohio, where a state law passed in 2004 (and then litigated until 2012) required that it be administered and prescribed exactly per the FDA label. Planned Parenthood vigorously argued for off-label use in Ohio, which is how it uses the drug in most states. In 2011, the FDA released a post-marketing report that RU-486 was responsible for at least 14 maternal deaths and more than 2200 serious complications in the US and at least 5 deaths outside of the US. Nationally, the abortion pill accounts for about 20-25% of all abortions. Here in Ohio, all medical abortions combined are about 5%.
By our reading, there will be three changes which will most dramatically impact Ohioans. The first is that the gestation stage at which the drug is used will be almost doubled. Previously, it was legal to use the drug up to 49 days gestation. The new label, effective today, will permit it to be used to 70 days gestation - 10 weeks. Secondly, it will reduce the requirement that each dose of the drug be administered by a physician. Currently each dose must be taken in clinic (some have questioned if this is the actual practice in some clinics). Now, the first dose will be administered in office but the second dose will be taken at home or "at a place convenient" to the woman. The third change will lower the dosing requirements.
The 2016 standards, announced by the FDA today, state:
Mifeprex is approved, in a regimen with misoprostol, to end a pregnancy through 70 days gestation (70 days or less since the first day of a woman’s last menstrual period). The approved Mifeprex dosing regimen is:
- On Day One: 200 mg of Mifeprex taken by mouth
- 24 to 48 hours after taking Mifeprex: 800 mcg of misoprostol taken buccally (in the cheek pouch), at a location appropriate for the patient
- About seven to fourteen days after taking Mifeprex: follow-up with the healthcare provider
In addition to the complications noted above, Greater Columbus Right to Life has documented numerous botched abortions in women who were prescribed the RU-486 regimen locally in recent years. We will continue to monitor the available reports.
Today’s decision will undoubtedly have abortion advocates cheering that medical abortions will be available to more women, later in their pregnancies, with fewer visits to a doctor, and at a lesser cost. We cannot cheer. Despite the relatively low number of medical abortions in our state, they make up a large part of the documented complications from abortion. Intentionally expanding the availability and use of the abortion drug will increase the deaths of unborn children and put more women in physical danger. That the FDA amended this drug label despite its own documented adverse affects is unconscionable and suggests that this is a political decision made at the request of the abortion industry.
Abortion shows a fundamental disregard for the dignity of human life. It is a horrific and barbarous practice regardless of how it is performed or at what stage the child’s humanity is taken. Today’s move by the FDA is a step in the wrong direction. We will update you as additional information is made available, including information on how state regulatory entities respond.
Note: RU-486 works by blocking progesterone in the body. Without progesterone, a pregnancy cannot continue. For this reason, some people compare the abortion pill to intentionally inducing a miscarriage. In Ohio, the abortion pill has traditionally been regulated in the same manner as a surgical abortion, although recent policy changes have resulted in several new "pill mills" being opened outside of an ambulatory surgical facility environment. Medical abortions are different than so-called emergency contraception, which works in the same way that most hormonal birth control pills work. Many people are confused by the distinction between the abortion pill, which intentionally ends an established pregnancy, and the “morning after” (also called “Plan B”) pill, which can act as an abortifacient by preventing the implantation of a recently fertilized ovum. Here is a fact sheet from the Association of Reproductive Health Officials that offers an explanation of the difference. We provide this as an explanation, not as an endorsement. GCRTL policy opposes all abortifacients.
Note 2: This entry will be updated for content at our discretion. Any changes are to increase clarity.
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