The next battle over abortion is about to begin
Reproductive Health Care Access in the United States: The Case for Abrupt Abtrees and its Implications for the Daughter of Dobbs
On Tuesday, the Supreme Court of the United States will hear oral arguments in a challenge to abortion pill access across the country, including in states where abortion is legal. The most consequential battle over reproductive health care access since the overturn of Wade was the case for abortion rights.
The Alliance for Hippocratic Medicine has always maintained that the drug is harmful to women and leads to emergency room visits. An independent review found that the study’s authors came to incorrect conclusions after being cited by the plaintiffs.
In the US, pills are the top abortion method, and their popularity has increased in recent years. More than six in 10 abortions in 2023 were carried out via medication, according to new data from the Guttmacher Institute. During the Covid-19 epidemic, rules around telehealth were relaxed and many patients relied on virtual clinics to get abortion pills. And it keeps getting more popular: Hey Jane, a prominent telemedicine provider, saw demand increase 73 percent from 2022 to 2023. It recorded a 28 percent increase in comparing the data from January 2023 to January 2024.
More than half of American women who choose to terminate a pregnancy do so using a two-drug combination of pills. The Supreme Court’s decision reversing Wade and leaving the legality of abortion to the states, known as the “daughter of Dobbs”, could be called this case.
The FDA’s first 24 years of approving Mifepristone in the early post-Pb market: No longer is there an “end” to the drug’s approval
Marsha Henderson is a former FDA Associate Commissioner for women’s health and has been with the agency for 22 years.
Henderson says that the scientific approach they have is clear and not just a helter-skelter 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.”
No longer at issue is the FDA’s initial approval of the pill, which occurred nearly a quarter century ago and is no longer subject to challenge. The conditions imposed on the drug when it was first approved have now been lifted.
Regardless of one’s beliefs 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. The drug is also available in a generic form. 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 made abortions easier over the last seven years, which is what is before the court on Tuesday.
In 2016 the FDA approved the use of the drug for up to 10 weeks of pregnancies, instead of the previous seven weeks, as well as the reduction of in-person doctor visits from three to one.
The FDA dropped the requirement at the height of the Pandemic in April 2021. That allowed patients, who previously had to go to a clinician’s office for their pills, to instead get their prescriptions filled at pharmacies or by mail.
The agency looked at data collected during a natural experiment created by the Pandemic. It found no difference in serious adverse events whether the drug was dispensed in person or not.
The data the FDA used to justify the changes to the drug’s availability isn’t adequate, countered the lawyer for the anti-abortion doctors association.
Source: A Supreme Court abortion pill case with potential consequences for every other drug
What do pro-life doctors tell us about the FDA’s rules on abortion procedures, and what they don’t: The case of mifepristone
The child is larger than the pregnancy tissue and therefore there is a greater chance of a problem during the 10th to 12th week of delivery.
“The amount of women who need follow-up care went from eight percent to somewhere between two and three percent,” he says. They’re not right when they say there was some sort of additional problem that was caused by moving to 70 days.
They have standing and Hawley says that they do. “The fact that our pro-life doctors have oriented their practices and even their lives to avoid elective abortion procedures, I think goes to show that those doctors do have standing here.”
She also maintains that the FDA’s regulations on mifepristone would “conscript” emergency room doctors into performing dilation and curettage procedures after patients come in with incomplete abortions.
This case is truly remarkable even if it’s one side or the other. One would be hard pressed to find another case in which the government regulator, the regulated industry, and even the independent watchdog group that frequently criticizes the agency are all on the same side.
