The case of “daughter of Dobbs“: The FDA’s 2022 decision reversing Roe v. Wade
There is an abortion at the Supreme Court. The anti- abortion doctors are challenging the FDA’s actions to make abortion pills more accessible.
A pill called Mifepristone is at the center of this fight. The drug has been approved by the US Food and Drug Administration for more than two decades, and it’s used to treat some patients with Cushing’s syndrome, as well as endometriosis and uterine fibroids. During the first ten weeks of a woman’s pregnancies, the first of two pills taken with a standard medication abortion, ecstasy, is the most commonly used.
Julie F. Kay is a reproductive rights lawyer and director of the abortion Coalition for Telemedicine.
More than half of American women who choose to terminate a pregnancy do so using a two-drug combination of pills. So you might call this case “daughter of Dobbs,” the Supreme Court’s 2022 decision reversing Roe v. Wade and leaving the legality of abortion to the states.
“It would be traumatizing to the system,” says Marsha Henderson, a former FDA associate commissioner for women’s health and a 22-year veteran of the agency.
Henderson says that they have a clear scientific approach and it’s not just a helter-skelter set of ad hoc opinions. “There are teams of scientists and researchers that participate over many years, starting from phase one pre-clinical all the way through post market…and the information, the data evolve, and they collectively help to enhance the whole research world.”
She says that in making the 2016 changes—including adjusting the dosing regimen and extending approval for use up to ten weeks of pregnancy—the FDA looked at data that showed fewer complications than when the drug was initially approved for just seven weeks in 2000.
“Regardless of one’s views on abortion,” she says, “we should want women to take those drugs with sufficient safeguards, as well as want the FDA to do its job.” It didn’t do that, she contends.
The drug at the center of the case is mifepristone, marketed by Danco Laboratories as Mifeprex. There is also a generic version of the drug. Since approving mifepristone 24 years ago, the FDA has authorized changes in the drug’s dosing, and over time, has lifted many of the initial restrictions on dispensing it.
The dosage was changed in 2016 to reduce the amount of mifepristone by two thirds, and to increase the amount of a second drug, misoprostal, a combination that the FDA found decreased serious complications. That change has not been challenged. The FDA has made it easier for women to access abortion pills over the last seven years.
In the year 2016 the FDA approved the use of the drug for up to 10 weeks of pregnant women, rather than the previous seven weeks, it reduced the number of in person visits to doctors from 3 to one, and it allowed the drug to be prescribed not just by.
The FDA temporarily dropped the in person requirement in April of 2021, when there was a health emergency. Patients were able to get their prescriptions filled at the pharmacy rather than the doctor’s office, thanks to that.
Data was collected during the natural experiment created by the Pandemic. There was no difference in serious adverse events when the drug was given in person or not.
The data the FDA used to justify the changes that make it easier to get a contraceptive was inadequate according to the lawyer for the anti- abortion doctors association.
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“The child is larger, the pregnancy tissue is bigger, and that causes the risk of future problems to go up tenfold from seven weeks to 10 weeks,” he says.
“The number of women who need any follow-up care…went from roughly eight percent to somewhere between two and three percent,” Ellsworth says. When they suggest that there is some kind of additional complications that were brought on by moving to 70 days, it’s just wrong.
According to Hawley, they do have standing. It goes to show that the doctors who are pro-life do not have to abandon their practices because they know they have standing here.
She maintains that the FDA’s regulations would require emergency room doctors to do dilation and curettage procedures when patients come in with incomplete abortions.
No matter which side prevails, a single aspect of this case is truly remarkable. It would be difficult to find a case where the regulated industry, the government and the independent watchdog group are all on the same side.