Medication abortion battlefield: Lawsuit challenges FDA’s drug review process

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

In late February, attorneys general from nearly a dozen Democratic-led states sued the US Food and Drug Administration over rules they say are medically unnecessary and make it harder for people to obtain mifepristone. are for FDA has eased some restrictions over the years, but a mifepristone prescription still has many qualifications under the Risk Evaluation Mitigation Strategy aka REMS.

But others claim that the FDA’s regulations are not strict enough. Whether mifepristone is able to stay on the US market may depend on a decision by a judge in Texas, which has already banned abortion for the state with narrow exceptions, and a decision could come any day. In part, the lawsuit claims the FDA did not have the authority to approve mifepristone in the first place, and it questions the drug’s safety despite medical organizations maintaining it is safe. If judges agree, the case has the potential to ban mifepristone and change the way drug abortions are performed. states where abortion is legalHowever, other legal steps and appeals are expected to follow soon.

Medication abortions are usually limited to the first trimester of pregnancy and account for an increasing number of total U.S. abortions — currently more than half. Medical organizations including the American Medical Association and the American College of Obstetricians and Gynecologists state that mifepristone is safe. Patients may choose medication abortion because it is performed in the privacy of their home and may be more accessible or less expensive than an in-clinic procedure. After the US Supreme Court overturned Roe. V. Wade last spring, restricting abortion pills became a priority for lawmakers trying to ban or limit abortion.

Whatever the Texas judge rules, a stream of appeals and other court steps are expected to follow, making it difficult to say with certainty what will happen to mifepristone. Health care providers and legal experts alike say that of course post-Roe v. Wade, when the future and legality of medicine used in pregnancy and abortion is up to state actors and the courts.

But in the Texas case, in particular, the FDA’s approval process is called into question. According to an article in The New England Journal, if a judge revokes the agency’s more than 20-year stamp of approval for a drug, it would override the FDA’s own calculations on the drug’s benefits and risks. An “unprecedented” step in drug regulation. Of medicine Even if mifepristone remains on the market, the case has opened the door for potentially removing 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 drug that is used in the treatment of early miscarriage along with medication abortion in the first trimester. It temporarily blocks the hormone progesterone, which is essential for maintaining and developing a pregnancy. Patients using it for abortion take it before misoprostol, a drug that induces uterine contractions, to initiate the end of the pregnancy. Patients who have had a miscarriage can take it even when the pregnancy is no longer viable and the development of the embryo or fetus has stopped.

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

Mifepristone has been in the spotlight in the abortion debate because its sole purpose and approval is for pregnancy termination.

Plaintiffs in the Texas case include the Alliance for Hippocratic Medicine, a health care group against abortion and similarly socially divisive yet medically based topics, such as measurable suicide. The lawsuit claims that the FDA did not have the authority to approve mifepristone and that it has harmful side effects. The suit also takes issue with pregnancy as a disease, and the FDA regulating mifepristone as if it were. The real threat to mifepristone’s future on the market depends on a few factors.

Effects on FDA’s drug regulations

I. Glenn Cohen, a Harvard law professor and faculty director of the school’s Petri-Flom Center for Health Law Policy, said, “If the court decides against the FDA, how big a risk it is depends on whether the opinion how it is written.” said in an email. Cohen is also a signatory to an FDA law scholar amicus brief for the Texas case, and an author in an article on the case published in The New England Journal of Medicine. An opinion can be more narrow and focused on pregnancy, Cohen said, or it can be worded more broadly. If it is widespread, it has the potential to influence decisions on other drugs for other health conditions. But that would start a long process that would involve the Justice Department and other factors, according to Cohen.

Cohen said that the nationwide injunction that “essentially allows a district court judge anywhere in the country to make decisions for the entire nation” has drawn many skeptics, including two conservative Supreme Court justices.

If the judge rules in favor of the Alliance for Hippocratic Medicine and voids the FDA’s 20-plus year stamp of approval, it will override the FDA’s benefits versus risks calculations. Cohen and other authors wrote in the article that it would be unprecedented for a judge to override “a process created by Congress” in drug regulation. The scope of the injunction – whether mifepristone is banned nationwide – will need to be determined in other courts, and such a decision has the potential to go all the way up to the Supreme Court.

Not only could it change the way the FDA weighs a drug’s benefits and risks, but it would open the door for the court to remove other drugs from the market outside of drugs used in pregnancy or abortion, including vaccines. and gender-affirming drugs. Legislators have become politicised. And as noted in Slate, the fate of medication abortion also depends on how much power the FDA wields, and how it exercises its enforcement discretion.

But the FDA is not the final frontier in its effort to stop medication abortions. Also in Texas, lawmakers introduced a bill last week that aims to block websites containing information on pharmaceutical abortion drugs or sites where people can find the pills, which would include foreign pharmacies such as Edexcess. Even in states where abortion is currently prohibited, people can order the pills from these sites because they are not regulated by the FDA.

Medication abortion can only be continued with misoprostol.

Misoprostol itself is the other recommended method of medication abortion, and may already be a preferred regimen for many people in non-wealthy countries who do not have access to mifepristone.

Many health care providers are expected to continue prescribing misoprostol for medication abortion where abortion is legal, including online. Even if mifepristone is banned, misoprostol will remain available to patients, said Monika Sepak, chief marketing officer for sexual and reproductive telemedicine site Wisp.

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

But while studies show that misoprostol alone is effective at terminating a pregnancy, it is not quite as effective as the mifepristone-misoprostol combination and may cause more pain and side effects, including emergency room follow-up care in one’s body. Also included is the requirement. OB-GYN and assistant professor at Rutgers Robert Wood Johnson Medical School, Dr. Pregnancy does not pass, says Glenmary Matthews. She says banning mifepristone only took a safe process and made it less safe.

Will providers still be comfortable performing misoprostol-only abortions?

“It’s not a matter of feeling comfortable,” Mathews said. “We will still have to have medication abortions with misoprostol because women will still need medication abortions.”

Even if the judge in Texas doesn’t rule in a way that blocks mifepristone nationwide, lawsuits like this one still affect abortion because they’re an OB-GYN in Portland, Oregon, and Dr. Let’s add to the stigma, according to Jennifer Lincoln. May Day.Health.

“It’s further restricting and adding unnecessary shame and stigma to drugs with over 20 years of data that are completely safe,” Lincoln said.

Mathews says the ban on medication abortion exacerbates existing gaps in access to health care across America.

“Of course, people of color and lower socioeconomic status are again going to be more affected because they’re the ones who don’t have the resources to get their medication,” Mathews said, referencing the current burden of obtaining misoprostol. Pharmacies may be reluctant to give misoprostol to people who are already pregnant.

The US has the highest maternal mortality rate of all wealthy countries. Black women are almost 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 to be health or medical advice. Always consult a physician or other qualified health provider with respect to any questions you may have regarding a medical condition or health objectives.