Medication abortion remains a battleground, this time beyond FDA authority

The future of medical abortion is mired in lawsuits over the availability and legality of mifepristone, the first of two drugs used in the procedure.

Last week, attorneys general from about a dozen Democratic-led states sued the U.S. Food and Drug Administration over regulations they say are medically unnecessary and intended to make it harder for people to get mifepristone. But whether the drug can remain on the market could depend on a Texas judge’s decision, which could come any day. The judge is ruling on a lawsuit that claims, in part, that the FDA never had the right to approve mifepristone in the first place and questions the safety of the drug, despite the fact that medical organizations still support it as safe. If the judge agrees, the case has the potential to ban mifepristone even in states where abortion is legalalthough a number of other legal steps and appeals are expected to follow immediately.

Medication abortions are usually limited to the first trimester of pregnancy and account for a growing number of the total number of abortions in the US — currently more than half. Medical organizations, including the American Medical Association and the American College of Obstetricians and Gynecologists, say its use for abortions is safe. Patients may choose medical abortion because it is done in the privacy of their own home and may be more accessible or less expensive than the in-clinic procedure. After the US Supreme Court overturned Roe. v. Wade last spring, restrictive abortion pills became a priority for lawmakers trying to ban or restrict abortions.

Whatever the judge in Texas decides, a series of appeals and other court moves are expected to follow, making it difficult to say for sure what will happen to mifepristone. Health care providers and legal experts say that’s the lesson after Roe v. Wade, when the future and legality of drugs used in pregnancy and abortion depends on state actors and the courts.

But in the case of Texas, in particular, the FDA’s approval process is being called into question. If the judge revokes the agency’s 20-plus-year stamp of approval on a drug, it would override the FDA’s own calculations of a drug’s benefits and risks — an “unprecedented” move in US medicine regulation, according to with article in The New England Journal. of Medicine. Even if mifepristone remains on the market, the case has opened the door to possible removal of other drugs and medications from the market, regardless of what the medical consensus is.

What is mifepristone and what is the Texas case?

Mifepristone is a medication used in first-trimester medical abortions as well as early miscarriage treatments. It temporarily blocks progesterone, a hormone needed to maintain and develop a pregnancy. Patients using it for abortion take it before misoprostol, a medicine that causes uterine contractions, to begin the end of pregnancy. Patients who have had a miscarriage may also take it to help their body stop behaving as pregnant when the pregnancy is no longer viable and the embryo or fetus has stopped growing.

On its own, mifepristone alone is not particularly effective at terminating a pregnancy, so the FDA specifically approved it for use with misoprostol, a drug originally intended for stomach ulcers and other health conditions. Misoprostol is technically used off-label for induced abortion (usually just “miscarriage”) or spontaneous abortion (miscarriage).

Mifepristone has been at the center of the abortion debate because its sole purpose and approval is to terminate pregnancy.

Plaintiffs in the Texas case include the Alliance for Hippocratic Medicine, a health care group opposed to abortion and similar socially divisive as well as medical issues such as medically assisted suicide. The lawsuit alleges that the FDA never had the authority to approve mifepristone and that it has harmful side effects. The suit also challenges pregnancy as a disease and the FDA regulating mifepristone as if it were. The real threat to the future of mifepristone in the market depends on a number of factors.

Implications for FDA drug regulations

“If the court rules against the FDA, part of the threat depends on how the opinion is written,” I. Glenn Cohen, a Harvard law professor and faculty director of the school’s Petrie-Flom Center for Health Law Policy . he said in an email. Cohen has also signed an FDA legal scholar amicus brief in the Texas case and authored an article on the case published in The New England Journal of Medicine. An opinion could be more narrow and focused on the pregnancy, or it could be written broadly, Cohen said. If broad, it has the potential to influence decisions about other drugs for other health conditions. But it will begin a lengthy process involving the Justice Department and other actors, according to Cohen.

Cohen added that national mandates that “essentially allow a district court judge anywhere in the country to make decisions for the entire country” have drawn much skepticism, including from two conservative Supreme Court justices.

If the judge rules in favor of the Alliance for Hippocratic Medicine and revokes the FDA’s 20-plus-year stamp of approval, it will override the FDA’s benefits versus risk calculations. For a judge to override this “process created by Congress” in drug regulation would be unprecedented, Cohen and the other authors write in the article. The scope of the order — if mifepristone is banned nationwide — will have to be determined in other courts, and such a decision has the potential to go all the way to the Supreme Court.

Not only could it change how the FDA weighs the benefits and risks of medication, but the court would open the door to removing drugs other than those used in pregnancy or abortion, including vaccines, from the market. and gender-affirming drugs that have been politicized by lawmakers. And as Slate reports, the fate of medication abortion also depends on how much power the FDA retains and how it uses its enforcement discretion.

But the FDA is not the last frontier in an effort to stop medication abortions. Also in Texas, lawmakers introduced a bill last week that aims to block websites with information about abortion drugs or websites where people can find the pills, which would include overseas pharmacies such as AidAccess. Even in states where abortion is currently banned, people can order pills from these sites because they are not regulated by the FDA.

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Medical abortions can only be continued with misoprostol

Misoprostol alone is the other recommended method of medical abortion and may already be a treatment for many people in non-rich countries who do not have access to mifepristone.

Many health care providers are expected to continue to prescribe misoprostol for medical abortions where abortion is legal, including on the Internet. Monica Cepak, chief marketing officer of telemedicine reproduction website Wisp, said misoprostol would still be available to patients if mifepristone were banned.

And despite the outcome of the ongoing court cases, medical abortion pills will still be available at overseas pharmacies like AidAccess, and surgical abortion will remain an option where state laws allow it.

However, while studies show that misoprostol alone is effective on its own at terminating a pregnancy, it is not quite as effective as the mifepristone-misoprostol combination and may cause more pain and side effects, including the need for an emergency room visit if one’s body doesn’t get through pregnancy, says Dr. Glenmarie Matthews, OB-GYN and assistant professor at Rutgers Robert Wood Johnson Medical School. He says a call to ban mifepristone simply takes a safe procedure and makes it less safe.

Will providers still feel comfortable providing misoprostol-only abortions?

“It’s not about getting comfortable,” Matthews said. “We will still have to do medical abortion with misoprostol because women will still need medical abortion.”

Even if the judge in Texas doesn’t rule in a way that blocks mifepristone nationally, lawsuits like this one still affect abortion because they add to the stigma, according to Dr. Jennifer Lincoln, an OB-GYN in Portland, Ore., and director of Mayday .Health.

“It just further limits and adds unnecessary shame and stigma to drugs that have over 20 years of data that are perfectly safe,” Lincoln said, adding that medical abortion pills “send fewer people to the hospital than Tylenol and Viagra.”

Matthews says bans on medication abortions widen existing gaps in access to health care in the US.

“Obviously, people of color and people of lower socioeconomic status are going to be hit harder again because they’re the ones who won’t have the resources to get their medications,” Matthews said, referring to the existing burden of getting misoprostol from pharmacies that already can be reluctant to give misoprostol to pregnant women.

The US has the highest maternal mortality rate of any rich country. Black women are about three times more likely to die during pregnancy, childbirth, or the postpartum period.

The information contained in this article is for educational and informational purposes only and is not intended as health advice or medical assistance. Always consult a physician or other qualified health care provider with any questions you may have about a medical condition or health goals.

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