A court ruling is threatening abortion pill access

The FDA’s case against misoprostol: The case for medical abortions, and the resurrected obscenity laws

The FDA didn’t properly approve a drug that has been available for more than 20 years for medical abortions, a federal judge ruled on Friday. The drug in question, mifepristone, is used along with one other drug in most medication abortions in the U.S.

In a statement, President Joe Biden called the decision “another unprecedented step in taking away basic freedoms from women and putting their health at risk,” saying his administration would continue to fight it in court. He called on voters toelect legislators who would protect abortion access, saying it was the only way to stop the same decisions happening again and again.

None of the drugs or the medication abortions are legal in these states. Misoprostol itself remains legal when used for other purposes, like treating ulcers or inducing labor.

The case is also notable for relying on the Comstock Act, a 150-year-old obscenity law that, among other things, bans the shipping of materials related to abortion. The opinion approvingly interprets the ban on any article, substance or drug that is advertised or described in a way that is calculated to lead another to use it or apply it for producing abortion as a ban on mailing it. The statute does not require intent on the part of the seller to be used unlawfully, writes Kacsmaryk. It’s the latest sign that long-dormant obscenity rules are being resurrected following an unsuccessful attempt to ban books in Virginia using a mostly forgotten state statute.

But in the short term, the ruling’s potential effects are muddy and reliant on the Fifth Circuit Court of Appeals, which could reverse the stay. (The Fifth Circuit is notably the one that allowed a ban on internet moderation to stand in 2022.) In February members of the nonprofit Women’s Law Project pointed out that the FDA could limit the ruling’s effects even if it were not allowed to stand. The response could affect whether patients have access to the pill in the face of legal uncertainty.

Preventing Abortion via Misoprostol and Aid Access in the United States and Newsom’s office on Tuesday announced an emergency stockpile of 2 million pills

Doctors will use only the other drug, misoprostol, if there is a possibility of this happening. How safe and how easy it is for a patient to get an abortion are among the things that can be learned from this information.

The so-called abortion pill in the US is Mifeprex or Korlym and can only be taken 24 to 48 hours later.

There’s lots of research that shows the misoprostol-only protocol is as safe as the two-medication protocol – but it does tend to cause more side effects.

If patients experience heavy or long-term bleeding, like spotting that continues for two weeks or bleeding so heavy that they soak through two hours worth of pads, they might need a procedure to complete the abortion.

A prolonged fever above 100.4 degrees Fahrenheit is also a reason to seek medical care. Even if you don’t suffer life threatening side effects such as chills and low-grade infections, they are a good indicator that you have a potentially life threatening disease.

The Food and Drug Administration has approved the two-drug regimen to end pregnancies up to 10 weeks gestational age, but the World Health Organization endorses it up to 12 weeks. After that, they’re less likely to be effective and may cause more bleeding and cramping.

Several states say they are stocking up on medications used to induce abortions as a major abortion pill appears poised to potentially become unavailable in the U.S.

Aid Access, for example, is based in the Netherlands and will mail mifepristone and misoprostol to patients in states where abortion is banned. Pills sent from abroad are not subject to FDA approval and safety regulations. U.S.-based health care providers are employed by the organization, who prescribe FDA- regulated abortion pills in states where they are allowed.

Gov. Gavin Newsom’s office says it’s made plans to secure an emergency stockpile of up to 2 million pills of misoprostol, a drug used in combination with another pill that is now the subject of legal battles in federal courts. The state already has around 25% of the pills it needs, which it was able to purchase for $100,000.

Meanwhile, Massachusetts Gov. Maura Healy said Monday afternoon that her state has stockpiled some 15,000 mifepristone pills or more than a year’s worth of doses. Last week, Washington Gov. Jay Inslee announced his state had prepared a stockpile of about three years’ worth of mifepristone.

Newsom’s office says the pills were secured through the state’s CalRx prescription drug program, and California is providing information about its purchase agreement to other states that may be interested in taking similar action.

If a pharmacy is facing a shortage they will be directed to a website where they can find information on how to request pills from the supply.

Prohibiting Abortion at Ohio Women’s Center and Other Reproductive Health Clinics Across the Country: Implications for Public Safety and Patient Safety

Less than a year after the US Supreme Court ended legal protections for abortions nationwide, clinics that provide reproductive health care across the country are bracing for more restrictions.

At Northeast Ohio Women’s Center, staffers are calling patients who expected to get medication abortions next week, telling them to change their plans.

It can be used to prevent bleeding between periods and to control hyperstimulation of the ovaries during in-vitro fertilization, the society said in a statement.

When a baby is too risky, time is of the essence according to Alison Edelman, who directs the division of Complex Family Planning at Oregon Health and Sciences University.

Studies also show that mifepristone has moderate to strong benefits for inducing labor and treating uterine fibroids and endometriosis, sometimes helping avoid surgery, according to the American Society of Health Systems Pharmacists.

Doctors say they still have other ways to treat those problems, but when considering the needs of individual patients, they will be missing a valuable tool.

“We have our gold standard of what we provide – the safest, most effective regimen – and then if it’s not available, we use the next best one. If we left with that, we would be left with nothing.

“They want to see a national ban and that is what they are going for in this case,” saidKristen Moore, director of the EMAA Project, a nonprofit that is seeking to make it easier to get abortion medications in the US

What Next? Misoprostol as a Mediator for the Treatment of Gastric Ulcers and Other NSAIDs

Things are not settled yet, what will happen next is unknown. Appeals have been filed to stop the ruling in Texas from taking hold, and higher courts will have to weigh in.

Carafem has been using a single regimen of drugs since the Covid-19 outbreak began, according to the COO.

According to the American Congress of Obstetricians and Gynecologists, the clinicians will have to use other options because they won’t be able to decide on their own. I do not want to be in that situation as a clinician.

Misoprostol is approved by the FDA to prevent and treat gastric ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs). It’s also used off-label for other types of blisters, and it has the ability to reduce blood loss and help with women who have miscarried.

“It’s a little old-school, but we could do it,” said Dr. Kristyn Brandi, an ob/gyn and abortion provider in New Jersey and a spokesperson for the American College of Obstetricians and Gynecologists.

“Many places around the country that don’t have access to mifepristone, often due to politics, have been using misoprostol-only regimens for a long time,” she said.

A person who uses this method is told to swallow four pills under their tongue for 30 minutes and then drink water from a container. They can also be used vaginally.

Heavy bleeding may last longer than two weeks, but there are no side effects at the FDA, and there are few barriers at the state and federal level

Typically, bleeding will begin within one to four hours after the first dose. Heavy bleeding can last longer than five hours, but it usually lasts two weeks or more.

“Again, it is safe. It is effective. It requires a different dosing, and you experience the symptoms a little bit longer,” Perritt said. “There are some other some additional side effects, like a longer duration of bleeding or more intense nausea or vomiting or gastrointestinal side effects, but when you look at that against the barriers that are put in place, both at the state and now the federal level for accessing abortion, many individuals still choose the second medication alone, because it is more convenient and easier, and it means you’re not walking through hundreds of protesters when you go to get care at your health care provider’s office.”

“We do use off label medications when clinically appropriate; however, that should not happen here because we have over two decades worth of clinically sound evidence based information that this is valid option,” Hoskins said.