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A federal lawsuit that has two of Montana’s abortion providers at the center of it has been filed in Virginia as the Center for Reproductive Rights has challenged the Food and Drug Administration for the way it has handled the requirements surrounding the drug mifepristone.
Blue Mountain Clinic and All Families Healthcare are both Montana providers that have joined with groups in Virginia, Kansas, Maryland, New Mexico, Illinois, and Minnesota to challenge the federal government’s restrictions they say have been unfairly and arbitrarily applied to the drug. Moreover, they say that drug’s long track-record and the burdensome paperwork that goes along with prescribing it is a function of political pressure, not an issue of medical science.
The lawsuit, which names the FDA and the United States Department of Health and Human Services as defendants, was filed on Monday in Virginia.
Two separate federal rulings have caused uncertainty, which is, in part, why the Center for Reproductive Rights said it filed the suit. Those two rulings — one from Washington and one from Texas — leave a patchwork of regulations, pending lawsuits, and restrictions regarding the drug, which is given along with misoprostol to end a pregnancy.
The lawsuit argues that the government has put several unnecessary and politically motivated restrictions on the drug, which they argue is statistically safer than over-the-counter medications such as ibuprofen or popular prescriptions like Viagra.
The suit references the uncertain legal setting after the U.S. Supreme Court struck down Roe v. Wade and replaced it with Dobbs v. Jackson Women’s Health. They argue that competing decisions in Texas and Washington have created an uncertain environment, making it nearly impossible for providers who are caught in the middle of trying to protect patient privacy and complying with federal, and, in some cases, ever-changing state law.
Mifepristone has been used and approved for abortion for 23 years by more than 5 million Americans. The plaintiffs in the lawsuit argue that the drug has been subjected to requirements, including the use of the “risk evaluation and mitigation strategy” or REMS system. They argue that those protocols are used only for drugs with a high rate of adverse effects, like allergic reactions, chemical interactions with other drugs or food, or drugs that can have moderate to severe side effects.
“By making mifepristone seem uniquely dangerous, FDA’s continuing restriction of mifepristone stigmatizes medication abortion and contributes to the chaos anti-abortion activists now sow,” the suit says. “Plaintiffs are continuously facing the weaponization of the REMS by anti-abortion activists around the country.”
They point out that even after the U.S. Court of Appeals for the Fifth Circuit halted Texas federal judge Matthew Kacsmaryk’s nationwide ban on the medication, it didn’t leave the old rules in place but modified them unreasonably – for example banning mid-level practitioners, like nurse practitioners, from prescribing the drug and banning its use in telehealth, something that had been allowed before the court battles.
“Plaintiffs – independent abortion providers with limited resources in hostile states – are caught in the middle of this maelstrom,” the suit says. “They provide care in states that are party to neither case and thus in a particularly precarious and uncertain position. Plaintiffs cannot retool their practices overnight with no notice – health care has no on/off switch. They and their patients require clarity.”
They are urging the federal government, via a court order, to remove the REMS restrictions that force additional paperwork and certification. They believe eliminating the REMS requirement will lessen the chance that patients’ private medical data are turned over to other authorities.
Safer than aspirin?
The FDA itself has researched mifepristone and determined that serious or adverse events associated with it are “acceptably low.”
A 2016 review from the National Institute of Health showed that “major adverse” events was roughly. 0.3%, while other studies pegged the rate of infection at 0.015%. The suit points out the drug has been in used in more than 600 published clinical trials and 800 peer-reviewed medical journals.
From 2000 to 2016, there were only 13 deaths even possibly linked to the medication, and none were causally linked to the drug.
“In either case, that is far less than the risk of death from the use of Viagra or over-the-counter, medications such as acetaminophen,” it says.
The lawsuit notes that Tylenol reports more than 500 deaths per year and is among the most common reasons for liver transplants. Meanwhile, Viagra has a mortality rate six times higher than mifepristone.
The FDA noted that the risk, more probably, was linked to “pregnancy itself” and the same problems can occur during a miscarriage or surgical abortion.
It found no significant outcomes based on whether the medication was issued by a doctor or mid-level practitioner, or via telehealth.
The challengers also note that while mifepristone is prescribed for abortion, it has other uses, but those aren’t subject to the same regulation. The drug Korlym has as much as six times the amount of mifepristone as the prescription used for abortion and is not subject to the same paperwork. It’s used to treat Cushing’s syndrome, a disease affecting the pituitary gland. As many as 15 million people have the disease, according to the Endocrine Society.
Targeting the already vulnerable
The lawsuit argues that requiring the services of a doctor and mandating a clinic visit were unreasonable restrictions the government placed on the medication, even after its own research proved the drug’s safety.
“Many people seek medication abortion with mifepristone because it can be easier to access, particularly for patients in communities facing the most obstacles to care,” it said.
“Medication abortion actively reduces what may be insurmountable barriers people face in access abortion care. People commonly take mifepristone at home following a consultation with a health care provider because they can have an abortion in privacy, at a place of their choosing, and with the support of their immediate network.”
The lawsuit brought by the providers points out that since the Fifth Circuit Court ruling, the FDA has imposed a pharmacy certification, which requires any pharmacy distributing the mifepristone to be “specially certified” to dispense the drug and keep records on it.
A paper trail for prosecution
The plaintiffs in the lawsuit argue that as some states adopt more aggressive measures against abortion, not just making it illegal but punishing providers who offer services, medical records could be targeted, leaving patient data at risk.
The suit says that additional paperwork imposed by the FDA on both providers and pharmacies is an overreach that could lead to the unintended prosecution of those who have abortions.
“If someone obtains access to the patient’s medical record – which is all the more possible with states criminalizing abortion and imposing civil liability for people assisting others in access abortion – they will have evidence that the patient received the medication for abortion,” the suit said. “This is a particular concern for patients who travel from a state where abortion is banned to a state where it is illegal.”
The suit says that it’s not just those seeking an abortion who may be affected, though.
The plaintiffs point out that signing off on paperwork is necessary in cases where patients received the drug in the miscarriage process. However, the paperwork require those patients to acknowledge they are taking the drug “deciding to end their pregnancy,” which could mean the patient would be targeted when they weren’t using the medication for an abortion.
The suit raises concerns about other information, such as spouses and family members who could be included in the data and later targeted because they knew someone who had an abortion. The lawsuit specifically mentions states that have attached penalties for those who help a woman have an abortion and payments to those who successfully report an illegal abortion.
“The legal battle over mifepristone is causing chaos for our clinics and widespread confusion and fear among those who need an abortion,” said Nicole Smith, executive firector of Blue Mountain Clinic. “We take care of patients from both Montana and our neighboring states who already face nearly insurmountable odds to receive essential abortion care. These restrictions perpetuate harm, stigma, and create unnecessary barriers to medication that is safer than penicillin.”
This article originally appeared in florida phoenix
