The New York Times explains why abortion is back at the Supreme Court

The FDA (F.D.A.) vs. Alliance for Hippocratic Medicine: Medical Evidence against the Use and Distribution of Mifepristone

The first case, scheduled for argument on Tuesday, F.D.A. v. Alliance for Hippocratic Medicine, is a challenge to the Food and Drug Administration’s protocols for approving and regulating mifepristone, one of the two drugs used for medication abortions. The F.D.A. relaxed the use and distribution of mifepristone in 2016 and then again in 2021, according to an anti-abortion physicians group. The agency changed their policies in 2016 in order to allow use of the drug up to 10 weeks of pregnancy rather than seven, reduce the number of required in-person visits for the drug’s distribution, and allow individuals like nurse practitioners to prescribe the drug. In 2021, it eliminated the in-person visit requirement, clearing the way for the drug to be dispensed by mail. The doctors want the court to throw out the regulations and make it easier for the state to control access to the drug in every state, regardless of abortion politics.

The study evaluated prospective patients using written medical questionnaires, issued prescriptions from doctors who were typically in Europe and had pills shipped to India from where it cost around $100. Community networks usually ask for information about the baby and will usually deliver or mail the pills for free.

Online vendors who supplied a small percentage of the pills in the study didn’t ask for women’s medical history, and sent the pills with the least detailed instructions. Plan C looked at vendors in the study and found that they were providing genuine abortion pills.

The Times of the First Laws – Reconfiguring Healthcare Access: The Case of Mifepristone at the Supreme Court of Appeals

Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.

That is the main issue in FDA v. Alliance for Hippocratic Medicine. There is an on one side are anti-abortion rights physicians. Their argument of how the FDA should not have approved it in 2000 has now been shifted to how it should have made it simpler to access in 2016 and 2021.

The FDA’s former commissioner argued in a brief that drug companies could use the case to challenge a competitor’s FDA approval. They wrote that there could be organizations representing patients who experience rare adverse events that try to bar access to safe and effective remedies for others.

“When the Supreme Court overruled Roe, the takeaway, if you will, from Justice Alito, was, ‘It’s time for this question to be returned to the people and their elected representatives,'” she observes. “And yet, fast forward less than two years later and we have two major abortion cases at the Supreme Court, both of which could very much reconfigure what happens in states.” (The other case, from Idaho, challenges federal rules requiring abortion during a medical emergency, regardless of state restrictions.)

The pill at the center of the fight is Mifepristone. The drug has been approved for more than 20 years by the FDA and is used to treat patients with a number of diseases. In the first 10 weeks of a woman’s pregnancy there are two pills taken in combination with a standard medication abortion.

Last August, the Fifth Circuit Court of Appeals ruled that FDA should roll back its prescribing rules to what they were in 2011. That would dramatically cut down on the number of people able to access this medication, for several reasons. It would shut down telemedicine access to the medication and could undo retail pharmacies’ new ability to dispense it.

It would also make it only available until seven weeks of pregnancy, instead of 10 weeks under the current rules, along with other changes. The medication can be used as late as 12 weeks.

Even though the difference between seven and 10 weeks might not sound like much, nearly half of medication abortions happen after seven weeks, according to CDC. At four weeks, is the earliest someone might find out they’re pregnant, according to Melissa Grant, COO of carafem.

A seven-week limit gives people three weeks, at most, “to get a positive pregnancy test, determine what option is best for them, potentially involve people that they care about in their lives, find an appointment, look at potential assistance for the finances of it, and then actually go and get the medication and use it,” she says. That’s a rapid change.

Is the Comstock Act a dead law? Dr. Joyce Ziegler discusses the case of mifepristone plus misoprostol

When someone has a miscarriage, doctors often prescribe the same mifepristone plus misoprostol regimen. The treatment can potentially ward off weeks of waiting, worrying and bleeding.

In an NPR interview, Brown claimed that she was terrified of starting bleeding on her long commute to work in Louisiana because there was no safe place to pull over. Taking mifepristone allowed her to plan ahead so she could be comfortable at home with her then-fiancé.

The Supreme Court’s ruling on abortion in 2012 resulted in a split in the states – about half of the states have enacted measures to restrict access, while the other half have implemented policies to protect access.

The case has been about one medicine, but it could be any medicine, according to Dr. Banks, who spoke in a press conference this month.

“The [FDA] regulatory process that we rely upon as an industry is rigorous and long and it’s expensive,” she explained, adding that it’s not a perfect process, but it’s predictable. If it can be undone by plaintiffs who morally object to a medicine and friendly federal courts, that predictability goes out the window, she said.

The uncertainty could make investors and drug companies hesitant to invest, and it could cause the drug industry to rethink how it works for patients and how much it costs.

“I think that’s why the pharmaceutical industry is nervous,” Ziegler says. If this is possible, with a drug that has been controversial, and which has a very, very low complication rate, what would stop anyone from taking it?

Legal scholars like Ziegler also note that there’s an even bigger way that this case could affect everyone in the country. “You have, lurking in the background, the possibility that the Comstock Act is going to be reinvented as an abortion ban,” she says.

The law prohibiting the mailing of things for “indecent” or “immoral” use was enacted in the 19th century. One of their arguments is that the statute was a straightforward statute and not a dead law.

Mifepristone is dangerous to women, and it leads to emergency room visits: A reply to Alito in a case overturning Roe v. Wade

Despite decades of scientific consensus on the drug’s safety record, the Alliance for Hippocratic Medicine has alleged that mifepristone is dangerous to women and leads to emergency room visits. A 2021 study cited by the plaintiffs to back up their claims was retracted in February after an independent review found that its authors came to inaccurate conclusions.

In his majority opinion in the case overturning Roe v. Wade, Justice Samuel Alito insisted that the high court was finally settling the vexed abortion debate by returning the “authority to regulate abortion” to the “people and their elected representatives.”