A case currently pending in Texas – Alliance for Hippocratic Medicine et al v. U.S. Food and Drug Administration – poses an unprecedented threat to medication abortion. If the judge issues an injunction, the current protocol for medication abortion will be prohibited nationwide, even in states where abortion is legal and protected by state law or constitutional amendment.
THE FACTS ON THE MIFEPRISTONE CASE
What are the basics of this case?
Alliance for Hippocratic Medicine et al v. U.S. Food and Drug Administration was deliberately filed in the Amarillo division of the Northern District of Texas. The case uses junk science to allege that the FDA erred 22 years ago in its approval of Mifepristone, one of two drugs used in medication abortion protocols in the United States. If an injunction is issued as the plaintiffs are requesting, Mifepristone will become unavailable for patients and providers throughout the country.
No state has the authority to circumvent the FDA in permitting administration or prescription of any medication; the outcome of this case will impact every state in the country, regardless of individual state laws. This includes states like Vermont where the right to reproductive liberty is enshrined in the state’s constitution.
Is Planned Parenthood involved in this court case?
Who is behind this lawsuit and what are their motivations?
This lawsuit is a politically motivated attack, instigated and funded by extreme anti-abortion actors to further their agenda to ban abortion, birth control, and other sexual and reproductive health care nationwide.
What is the path and timeline of this case?
An injunction could be issued as soon as Feb. 10. Regardless of whether the judge rules for the plaintiffs or the FDA, it is expected to go to the 5th Circuit Court of Appeals, and, ultimately, to the U.S. Supreme Court, where a majority of justices have demonstrated an appetite for restricting access to abortion at any cost. It is important to understand that although this case was filed in Texas, the ban on Mifepristone could take effect immediately nationwide, as the FDA’s approval of the drug applies to all states.
Who will be most negatively impacted by this case?
This case has the potential to have a devastating impact on millions of people across the country where access to abortion is already out of reach due to the overturning of Roe v Wade and states banning or severely restricting abortion. It will be compounded for patients who already face financial hardship and barriers to healthcare including BIPOC patients and patients in rural communities.
THE FACTS ON MEDICATION ABORTION
What is medication abortion?
Medication abortion, also known as the “abortion pill,” commonly refers to the process of using two drugs to induce an abortion early in pregnancy. The two drugs are Mifepristone, which blocks the hormone progesterone and stops the pregnancy from continuing, and Misoprostol, which causes the uterus to empty.
Medication abortion can be used up to 77 days, or 11 weeks, after a patient’s first day of their last menstrual period. Both drugs are extremely safe and effective and have been used by more than five million people to safely end their pregnancies. A complete description of the Mifepristone/Misoprostol medication abortion protocol can be viewed here.
What is Mifepristone?
Mifepristone is one of two drugs commonly used in a medication abortion. Mifepristone works by blocking the hormone progesterone. Mifepristone has been safe and legal in the United States since 2000, when the U.S. Food and Drug Administration (FDA) approved the brand name Mifeprex. In April 2019, the FDA approved the first generic form of Mifepristone, following a review of evidence that medication abortion is a safe, effective way to end an early pregnancy.
What is Misoprostol?
Misoprostol is the second drug used in the current standard medication abortion protocol. It causes the uterus to empty.
How effective is the Mifepristone/Misoprostol medication abortion protocol?
The Mifepristone/Misoprostol medication abortion protocol is extremely effective. Its efficacy is highest early in pregnancy, through approximately 11 weeks. The sooner the protocol is administered, the better the efficacy. In general, the Mifepristone/Misoprostol protocol has a success rate of more than 95%.
What percentage of PPNNE’s patients choose medication abortion?
Approximately 70% of our patients who decide to end their pregnancy in the first 11 weeks receive the Mifepristone/Misoprostol medication abortion protocol.
Why would someone choose a medication abortion over an in-clinic abortion?
People choose medication abortion for many reasons, such as the ability to end their pregnancy at home or in another setting where they feel most comfortable. Medication abortion also reduces barriers to care, such as travel to an in-clinic setting and paying for associated costs such as gas, lodging, or childcare. Some patients opt for medication abortion to avoid the potential harassment and intimidation of protesters at health centers.
Are the abortion pill and the morning after pill the same thing?
No. Medication abortion, also known as the abortion pill, ends an existing pregnancy. Emergency contraception, also known as the morning after pill or Plan B, prevents pregnancy from occurring.
What impact would an injunction or ruling against the FDA’s approval of Mifepristone have on PPNNE and its patients?
If the Texas judge issues an injunction, Planned Parenthood of Northern New England will be forced to change our medication abortion protocols and stop using Mifepristone. PPNNE will pivot to a Misoprostol-only medication abortion, which is just as safe as the dual drug approach. This will ensure we can keep access to medication abortion a vital option for all patients who need it.
Is a Misoprostol-only medication abortion as safe and effective?
A Misoprostol-only abortion is just as safe as a Mifepristone/Misoprostol combination abortion and is already used in other parts of the world where other medications may be harder to obtain. While a Misoprostol-only medication abortion is effective, this protocol is less effective and can cause more complications than the current standard Mifepristone/Misoprostol protocol. In addition, multiple doses of Misoprostol may be required for each patient.
Can Misoprostol-only medication abortion still be used up to 11 weeks of pregnancy?
PPNNE’s state affiliates in Maine, New Hampshire and Vermont operate under different laws regulating abortion. Will they all be affected?
Yes. No state has the authority to usurp FDA approval of any drug.
About Planned Parenthood of Northern New England: PPNNE is the largest provider of sexual and reproductive health care across Maine, New Hampshire, and Vermont. In FY22, PPNNE provided care to more than 36,000 patients for more than 52,000 visits. There are 15 health centers across the region. We serve New Hampshire residents through 5 health centers in Derry, Exeter, Keene, Manchester, and White River Junction, VT.