FDA Expands Access to Abortion Pill and Reaffirms That, Yep, It’s Still Super-Safe
By Miriam Berg | March 31, 2016, 3:31 p.m.
Category: Abortion Access
Yesterday, the U.S. Federal Drug Administration (FDA) approved new protocols for medication abortion that are rooted in science — not politics — and that encourage all 50 states to provide it through an evidence-based standard. Although this label change does nothing to get intrusive laws out of women’s exam rooms, it does represent a significant step forward for reproductive health.
The change is pertinent to women in states like Texas, Ohio, and North Dakota where anti-abortion restrictions and outdated protocols have prevented doctors from offering medication abortion using the most recent scientifically tested regimen — even though medication abortion is a safe and effective option to end an early pregnancy, and despite the facts that the updated regimen causes fewer side effects and results in fewer trips to the clinic.
How the New Label Increases Access to Medication Abortion
The new FDA-approved printing label is for mifepristone, which is known as the “abortion pill” and was formerly known as RU-486. Mifepristone induces abortion in early pregnancy, giving women an alternative to aspiration (suction or surgical) abortion.
Until today, the regimen outlined on mifepristone’s label was based on clinical trials from way back in the ‘90s. The new label now aligns with recommendations from the American College of Obstetricians and Gynecologists and others. All in all, the new label brings the standard of care up-to-date in every state. In particular:
- It recommends a lower dosage of mifepristone and a higher dosage of another medicine used in medication abortion. When states required doctors prescribe more mifepristone than patients needed, it made the treatment significantly more expensive.
- It allows mifepristone to be used three weeks later in pregnancy than the original label (up to 70 days’ gestation).
This update poses the biggest benefit for women in Ohio, Texas and North Dakota, where restrictions have compelled health care providers to use the outdated, inferior, and less effective regimen when prescribing medication abortion.
The FDA’s approval of the new label for medication abortion — which promotes a regimen that causes fewer side effects and results in fewer trips to the clinic — is based on substantial evidence demonstrating that medication abortion is safe for virtually all women. Studies show that:
- Medication abortion has a 99% safety record.
- Medication abortion is up to 98% effective in ending an early pregnancy.
The Real-World Impact of the FDA’s Change
Setting aside other restrictive state laws that interfere with the doctor-patient relationship and the provision of abortion in Texas, Ohio and North Dakota, the FDA’s approval of the new label means that medication abortion can once again be provided everywhere in the U.S. in accordance with what research shows is safest and most effective. Because of the FDA’s announcement, abortion providers in these states will no longer be forced to provide medication abortion according to an outdated regimen that the American Medical Association and the American College of Obstetricians and Gynecologists agree is inferior.
Similar restrictions on medication abortion passed but have been blocked by court order in Arizona, Arkansas, and Oklahoma. In Arizona, the legislature has amended state law to require that providers follow the regimen outlined on the old label for medication abortion, regardless of scientific evidence and the new FDA-approved label.
Stand With Planned Parenthood
Simply put, the “new” protocol aims to improve the use of medication abortion. The FDA’s announcement is a significant step forward for science and women’s health — it means that health care providers can provide medication abortion according to the highest standard of care established after more than 15 years of research and experience. And THAT brings the nation one step closer to a place where access to health care doesn’t depend on who you are or where you live.
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