The Supreme Court has a case against it
Do doctors argue that the FDA should not approve mifepristone? The case for abortion rights in the United States and the Supreme Court
There is one issue in FDA v. Alliance for Hippocratic Medicine. There are physicians against abortion rights on the other side. Originally, they argued that the FDA should not have approved mifepristone in 2000; now they’re focusing on the argument that it should not have made it easier to access in 2016 and 2021.
In another amicus brief, former FDA commissioners argued that drug companies could make use a precedent set by this case to challenge a competitor’s FDA approval. Or, they write, “organizations representing patients who experience rare adverse events could challenge FDA’s risk-benefit analyses and attempt to bar access to safe and effective remedies for others who need them.”
She says Justice Alito told them it was time for the question to be returned to the people. “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.)
At the center of this fight is mifepristone, a pill that blocks a hormone needed for pregnancy. The drug has been approved by the FDA for over 20 years and is used in some cases to treat disorders like endometriosis and uterus disorders. But its primary use is the one contested now—mifepristone is the first of two pills taken in the first 10 weeks of pregnancy for a standard medication abortion, along with the drug misoprostol.
“We use this medication for a variety of purposes, including for conception and loss of the baby,” explains Dr. Perritt, who is also the President of Physicians for Reproductive Health. She says that no one will be able to get access to it if it is banned or restricted.
It would also make it only available until seven weeks of pregnancy, instead of 10 weeks under the current rules, along with other changes. (Globally, the medication can be used as late as 12 weeks.)
Although the difference between 7 and 10 weeks might be small, nearly half of medication abortions happen after seven weeks according to the CDC. Melissa Grant, COO of carafem, which runs abortion clinics and provides telemedicine abortions, explains that’s because the earliest someone might find out they’re pregnant is at four weeks.
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 very fast turn around.
Why Should Medical Practitioners Be Worried About the FDA? The Case of Mifepristone plus Misoprostol, Dr. Amy Banks
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.
She toldNPR that after she found out her baby wasn’t hers, she was worried that she would end up bleeding on her commute to work in Louisiana. Taking mifepristone made her feel at home with her now-fiancé.
In the nearly two years since the Supreme Court overturned Roe, states have moved in two opposing directions – about half of states ban or seriously restrict abortion, and the other half have passed measures to protect access.
“This is only a case about one medicine, but it could be any medicine,” Dr. Banks said at the press conference.
She said that the FDA process is expensive and rigorous, but that 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 affect investors and drug companies and “could put innovation for new drugs and much, much needed therapies for patients, not just in the United States, but globally, at fundamental risk,” Banks said.
That’s why the pharmaceutical industry is worried, says Ziegler. If this could happen with a drug that has been well studied, that has a low chance of side-effects, and which is known to work well, then what would stop other drugs from doing it?
This case could affect everyone in the country, that’s what legal scholars like Ziegler say. She says that there is a chance that the Comstock Act will be reinvented as an abortion ban.
The mailing of things was not allowed under the Comstock Act of the 19th century. The plaintiffs in this case use Comstock in one of their arguments, treating it as a straightforward statute and not a defunct law.
Mifepristone may be dangerous to women and to children: The Alliance for Hippocratic Medicine argues that it does not lead to emergency room visits for women
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. In February, a study that was cited by the plaintiffs to back their claims was found to come up with incorrect conclusions.
Julie Kay is the director of the Abortion Coalition for Telemedicine.
