The American College of Obstetricians and Gynecologists (ACOG), the American Medical Association and 47 other organizations representing reproductive healthcare providers, researchers and advocates, filed a citizen petition earlier this month, urging the U.S. Food and Drug Administration (FDA) to increase access to mifepristone for miscarriage treatment.
Mifepristone is highly effective at treating incomplete miscarriages, but patients often cannot get the medication because the FDA tightly regulates the drug as an abortion medication. These restrictions, along with new state abortion bans enacted after the Supreme Court eliminated the constitutional right to abortion last summer, are creating barriers for patients needing mifepristone for treatment of incomplete miscarriages.
“The confusion that the opposition has sown with all their legislation plus the risk of criminalization equals chaos. And that just leads to cruelty. That’s what we’re seeing. People are being denied care in real time and lives are totally upended,” said Kirsten Moore, director of Expanding Medication Abortion Access (EMAA) Project, which joined the petition.
The FDA has approved mifepristone for pregnancy termination, but does not explicitly label the drug for use in miscarriage care.
The citizen petition asks the FDA to modify the drug’s label to add an indication for miscarriage treatment and to remove requirements that clinicians and pharmacies be certified to prescribe and distribute the drug, which create barriers to accessing the medication for miscarriage.
People are being denied care in real time and lives are totally upended.Kirsten Moore, director of Expanding Medication Abortion Access Project
Approximately 25 percent of all pregnancies end in miscarriage. To treat a miscarriage, some clinicians take a wait-and-see approach, with active monitoring in case symptoms such as infection develop and require intervention. Other clinicians offer medications to complete the miscarriage or manually empty the uterus.
For patients choosing medication, the gold standard is mifepristone in combination with misoprostol. Mifepristone interrupts the flow of the hormone progesterone that sustains a pregnancy and misoprostol causes contractions to expel the contents of the uterus. Misoprostol is commonly available medication used to treat ulcers.
Clinicians can prescribe mifepristone for miscarriages as an off-label use—a common practice with many medications that the FDA allows—but only if they are a certified prescriber, because the FDA tightly restricts mifepristone under the Risk Evaluation and Management Strategy (REMS) drug safety program. Because of this restriction, many clinicians in medical offices and emergency rooms cannot prescribe the medication.
As a result, the most commonly used medical protocol for miscarriage management today is misoprostol alone. But, research shows that the combination of mifepristone and misoprostol is faster and more effective for miscarriage care as well as less painful than misoprostol alone.
The lack of mifepristone labeling for miscarriage is making the medication vulnerable to bans in states hostile to abortion. Lawmakers in Alabama and Arizona recently introduced legislation to ban mifepristone.
“These are wholesale bans on mifepristone for any use and, if enacted, will prevent clinicians from providing the gold standard miscarriage care in their communities of practice, harming public health,” said the citizen petition. “Even without a wholesale ban on mifepristone, clinicians in states that ban abortion may be hesitant to prescribe a drug that has only been approved for abortion even for a legal, off-label use, like miscarriage management.”
Advocates hope that adding miscarriage management to the label would legitimate this important use and make it harder for states to ban the drug.
“The FDA has the authority delegated by Congress to regulate the safety of drugs and what should be on the market and how it can be on the market. States should not be able to override FDA authority,” said Moore.
We should be normalizing miscarriage, not because we want it to be normal, but because it is normal, and people should have access to the best treatments available.Kristen Moore
In addition to relabeling mifepristone, the petition asks the FDA to eliminate the requirement of clinician certification to prescribe and distribute mifepristone.
“ACOG is encouraging doctors to become certified prescribers if they wanted to do miscarriage treatment, even if they don’t want to do abortions. But they’d have to certify and say that they themselves were an abortion doctor, and that is a hurdle,” said Moore.
Requiring providers to become certified to prescribe mifepristone is not only an administrative burden, but it could open them up to risks of violence and harassment because of the medication’s association with abortion. The petition cites research showing that physicians who only planned to prescribe mifepristone for miscarriage care still feared becoming targets of anti-abortion protesters.
In addition to requesting the removal of the provider certification requirement, the citizen petition asks for removal of the pharmacy certification requirement as well. In the past, the FDA blocked pharmacies from distributing the medication, but they announced last December a new policy—yet to take effect—allowing certified pharmacies to distribute the medication. The citizen petition argues this requirement is unnecessary and creates barriers to access, especially for poor and rural women.
The petition asks the FDA to remove a requirement that patients receiving mifepristone sign an informed consent form saying they are using the drug for abortion.
“Asking a miscarriage patient to attest to having an abortion will confuse patients at best, but due to the prevalence of abortion stigma, it might also add emotional harm to their miscarriage experience,” said the citizen petition.
Moore emphasizes the urgency of these changes so that patients can access the best care possible in a time of crisis.
“If you’re talking about someone who’s seeking treatment for miscarriage, they want to go to their own healthcare provider and get their prescription filled as quickly as possible,” said Moore. “We should be normalizing miscarriage, not because we want it to be normal, but because it is normal, and people should have access to the best treatments available.”
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