Since the Supreme Court overturned Roe v. Wade last year, a legal fight has been underway in the federal courts over a widely-used abortion medication. A federal judge in Texas tried to ban it. Another federal judge in Washington state issued an order barring any action to reduce the drug’s availability. This week, a federal appeals court ruled in the Texas case that the abortion pill mifepristone can remain on the market for now, but with new restrictions. Health reporter Lynn Arditi explains what’s at stake and what Rhode Islanders need to know.
What’s at stake?
The abortion medication mifepristone, also known as RU-486 and sold under the brand-name Mifeprex, was approved by the Food and Drug Administration more than 20 years ago. About half of all abortions in Rhode Island and the U.S. are performed using mifepristone as the first of a two-pill regimen during the first 10 weeks of pregnancy. (Mifepristone is also used to help manage miscarriages.) Mifepristone is safer than some over-the-counter drugs like acetaminophen, the active ingredient in Tylenol, according to an analysis of an FDA report published by Advancing New Standards in Reproductive Health, a research program based at the University of California San Francisco.
If it’s so safe, why is the FDA’s approval threatened?
A coalition of abortion rights opponents filed a lawsuit in Texas challenging the process by which the FDA approved the drug in 2000. The federal judge in the case, a Trump appointee, sided with the plaintiffs and, in a preliminary ruling, declared the FDA’s approval invalid. He stayed his ruling until Friday to allow an appeals court to weigh in.
What happened this week?
A federal appeals court ruled late Wednesday that mifepristone can remain available nationwide while the federal case plays out, but effectively turned back the clock on restrictions for its use. The latest order, issued April 12, by a three-judge panel for the Fifth Circuit allows the use of mifepristone for up to seven weeks into pregnancy, instead of the 10 weeks previously allowed. The judges also rolled back other steps the FDA took starting in 2016 to make it easier for patients to access the pill. The latest ruling bars the drug from being sent to patients through the mail, prevents health providers other than physicians from prescribing or administering the drug, and requires three instead of one in-person office visit for a mifepristone prescription.
Do the new restrictions on mifepristone apply in Rhode Island?
Rhode Island has no plans to change the way it prescribes or administers mifepristone, say spokesmen from the state Office of Attorney General and the state Department of Health. [The state Health Department issued a formal advisory to that effect on April 17.] Rhode Island is one of 17 Democratic-led states and the District of Columbia where attorneys generals joined a federal lawsuit filed in Washington state seeking to force the FDA to expand access to mifepristone. The judge in that case, an Obama appointee, ruled April 7 that the FDA cannot alter access to the medication while the lawsuit proceeds. Connecticut and Maine also joined the lawsuit; Massachusetts did not. A preliminary injunction filed in the suit protects access to mifepristone in Rhode Island and the other states that joined the suit, the federal judge in the Washington state case reiterated in an April 13 order. That should prevent the FDA from imposing any further restrictions on mifepristone in Rhode Island and the other states that are plaintiffs in the case until the matter is clarified by the federal courts, said Brian Hodge, a spokesman for state Atty. Gen. Peter F. Neronha. The Justice Department filed a motion in federal court in Washington state on April 10 to clarify the conflicting circuit court rulings and said in a statement released Thursday that it plans to “seek emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”
Massachusetts and other Democratically-led states where abortion is legal are stockpiling abortion pills. What about Rhode Island?
Massachusetts Gov. Maura Heley enlisted the University of Massachusetts Amherst to purchase some 15,000 doses of mifepristone — close to two years’ worth — in anticipation of the Texas judge’s decision to invalidate the abortion medication. And California’s governor said his state secured 2 million doses of another abortion medication, misoprostol, often used in combination with mifepristone.
Rhode Island Gov. Dan Mckee said in a statement that “the Rhode Island Department of Health has been in touch with major pharmacies and providers in Rhode Island to ensure the medication being targeted in the Texas ruling continues to remain accessible.” The state Department of Health is “doing direct outreach to clinics and other facilities where mifepristone is dispensed to assess access in Rhode Island,’’ Joseph Wendelken, a department spokesman, said in an email.
How about hospitals’ supply of mifepristone?
Pharmacies at Rhode Island’s largest hospital system, Lifespan, “maintain a continuous and sufficient supply of all family planning medications,’’ Kathleen Hart, a Lifespan spokeswoman, said in a statement. Care New England operates Women & Infants Hospital, which also has an out-patient family planning clinic which provides abortion services. But Women & Infants side-stepped questions about its supply of mifepristone. “Mifepristone has an over two-decade history of safety and effectiveness and currently remains available for use in patients who meet the medical requirements,’’ the hospital’s president and chief operating officer, Shannon Sullivan, said in a statement.
If mifepristone ultimately becomes harder to access everywhere, would medication abortions still be available in Rhode Island?
Even if Rhode Island no longer had access to mifepristone, doctors and other reproductive health providers say that medication abortion would still be performed in Rhode Island. If mifepristone becomes unavailable, providers say, they will still be able to offer the second abortion medication, misoprostol, which is also used to help induce labor and as a treatment for stomach ulcers. Misoprostol is not subject to the same regulatory restrictions as mifepristone. But taken alone, misoprostol, which causes the uterus to contract and helps expel pregnancy tissue, is somewhat less effective and may have more side effects than when used in combination with mifepristone, which blocks a hormone necessary for pregnancy. (Whatever the outcome of the federal court cases on mifepristone, it is not expected to impact the availability of surgical abortions in Rhode Island.)
So if medication abortions are still available in Rhode Island, do these federal court battles have any impact here?
Even if Rhode Island is able to continue to provide surgical and medication abortions with no additional restrictions, doctors said, the cloud of uncertainty and confusion surrounding the court battles and shifting legal landscape have created barriers in themselves to accessing care. One Rhode Island doctor recalled seeing a patient recently in the emergency department who mentioned that they needed abortion care, but wasn’t sure if it was still legal. The doctor reassured his patient that abortion is, indeed, legal in Rhode Island.
This story has been updated.
Health reporter Lynn Arditi can be reached at larditi@thepublicsradio.org. Follow her on Twitter @LynnArditi
