Topline
The legality of abortion drug mifepristone is now in doubt after a conservative judge ruled Friday to block its federal approvals—which could have impacts beyond abortion, as mifepristone and other medications that can terminate a pregnancy can also be used for a range of other medical conditions, and those treatments may be affected by the court’s ruling and ongoing attacks on the drugs.
Key Facts
Medication abortion is traditionally a regimen involving two drugs: mifepristone, which terminates a pregnancy by blocking the hormone progesterone, and misoprostol, which induces contractions to expel the tissue, though medication abortion can also be performed using only misoprostol.
While mifepristone is primarily known as an abortion drug, it can also be used for miscarriages and early pregnancy loss, Kristyn Brandi, an OB/GYN and fellow at the American College of Obstetrics and Gynecologists, told Forbes, and has other gynecologic uses, like being used off-label as a treatment for uterine fibroids.
Mifepristone has already been targeted through legislation banning or restricting abortion pills, and Judge Matthew Kacsmaryk ruled Friday to revoke its approval by the Food and Drug Administration in response to a lawsuit from anti-abortion advocates.
If carried through, that’s expected to also impact its use for miscarriages and other gynecologic uses, as Abigail Long, director of public affairs at mifepristone manufacturer Danco Laboratories, told Forbes prior to the ruling that healthcare providers obtain mifepristone in “exactly the same way” for conditions like miscarriages as they do for using the drug for abortions.
Mifepristone is used in a different dosage and marketed as a separate drug as a treatment for Cushing’s syndrome, a rare endocrine disease that overproduces the hormone cortisol—which mifepristone blocks—though Leslie Edwin, the president of the Cushing’s Support and Research Foundation, told Forbes prior to the court’s ruling “there have been no interruptions to Cushing’s patient access to Korlym [the form of mifepristone used to treat it]
and there is no expectation for problems in the future.”
Mifepristone is also being used in clinical trials and through a compassionate use program as a treatment for conditions including multiple forms of cancer and depression, which Edwin and Long suggested to Forbes are arranged differently with manufacturers and pharmacies than when mifepristone is used for abortion and thus likely wouldn’t be formally legally affected by Kacsmaryk’s ruling.
That may not happen in practice, however: NBC News reported last year physicians already faced logistical issues with accessing mifepristone for clinical trials even before the Supreme Court overturned Roe v. Wade, and Allison Whelan, a law professor at Georgia State University specializing in health law, told Forbes prior to Kacsmaryk’s ruling the “biggest concern” is the “collateral consequences” that could come if “risk-averse” or anti-abortion pharmacies or pharmacists “[view] patients with skepticism” and refuse to prescribe mifepristone even if it’s for a different condition, if they’re afraid it could also be used for abortion.
Tangent
Misoprostol also has a number of other uses, including treating ulcers, inducing labor and early miscarriage management. While it hasn’t yet been subject to the same legal attacks as mifepristone, anecdotally there have already been reports of pharmacists denying patients access to the drug, helping spur the Biden Administration to issue new rules last year that required pharmacies not to restrict access to abortion-inducing medications. Some abortion providers have said they plan to switch to misoprostol-only regimens in the event of mifepristone being banned, which Whelan predicted means the “logical next step” for anti-abortion rights advocates will be to target misoprostol in court. That would “just greatly impact a large number of other conditions,” Whelan warned. Beyond mifepristone and misoprostol, there have also been widespread reports since the Supreme Court’s June ruling of patients being denied prescriptions for methotrexate, a drug used to treat such conditions as cancer, rheumatoid arthritis and other autoimmune diseases, because the medication can also be used to induce abortion.
What To Watch For
The Biden Administration has appealed the court ruling blocking mifepristone, and has asked the court to rule by 12 p.m. on Thursday. Kacsmaryk said in his ruling Friday that his order revoking mifepristone’s approval won’t take effect for a week, meaning there’s still time for the appeals court—or the U.S. Supreme Court—to block his decision before access to mifepristone is affected. It’s still unclear how mifepristone actually will be impacted by the ruling, as some lawmakers, including Republican Rep. Nancy Mace (S.C.) have urged the Biden Administration to ignore the ruling and assert that federal approval of the drug lies with the Food and Drug Administration and not the judiciary. Politico reported the White House is afraid that defying the order could jeopardize any appeals, however. A separate ruling also came out on Friday that actually expanded access to mifepristone, and the administration has asked that court to clarify how to square that ruling with Kacsmaryk’s decision given the conflict between them.
Surprising Fact
Health and Human Services Secretary Xavier Becerra warned Sunday Kacsmaryk’s ruling could also affect other FDA-approved drugs that don’t even have anything to do with abortion, given that it sets the precedent that plaintiffs can successfully sue to block federally approved drugs in court. “You’re talking about every kind of drug,” Becerra said, and experts have previously suggested a ruling affecting mifepristone could lead to similar cases against controversial vaccines, treatments for diseases like HIV or gender-affirming medical care, among other drugs.
Key Background
Medication abortions make up a majority of all abortions performed in the U.S.—53% in 2020, before the Supreme Court overturned Roe v. Wade—and mifepristone has been approved by the FDA for abortion since 2000. The drug regimen has become more integral to abortion access over the past year since Roe was overturned, as state-level abortion bans have shuttered clinics across the country, making abortion pills the easiest way for many people in states where the procedure is banned to obtain care. That has led to anti-abortion advocates ramping up their attacks on medication abortion in recent months, with lawmakers introducing bills targeting abortion pills specifically in addition to the lawsuit at the heart of Kacmaryk’s ruling. The Trump-appointed judge said in his ruling, which has been widely criticized by legal experts, the FDA was in violation of federal law when it enacted approvals around the drug, including allowing it to be mailed, and repeated claims contesting the safety of abortion pills, which numerous other studies have refuted.
Further Reading
Trump-Appointed Judge Halts Abortion Pill Mifepristone’s FDA Approval Nationwide (Forbes)
Abortion Pills: What To Know About Mifepristone As Biden Administration Defends It From Legal Attack (Forbes)
Ruling Against Abortion Pill Mifepristone Could Affect Other FDA-Approved Drugs, HHS Secretary Warns (Forbes)
The ‘abortion pill’ may treat dozens of diseases, but Roe reversal might upend research (NBC News)
Source: https://www.forbes.com/sites/alisondurkee/2023/04/11/mifepristone-ruling-here-are-the-unintended-health-consequences-of-attacks-on-abortion-pills/