Washington – Abortion providers across the country are preparing for a ruling from a federal judge in Texas that could disrupt access to a key drug used to facilitate medical abortion, and have made plans to ensure an alternative is available to patients if needed.
next resolution of US District Judge Matthew Kacsmarek In response to a request from anti-abortion medical societies for an order from the Food and Drug Administration (FDA) Withdraw her consent of mifepristone.
Kacsmaryk has scheduled a hearing Wednesday for the doctors’ groups and the Biden administration to press their arguments about the legality of Mifepristone’s approval, According to the Washington Post. The judge in Amarillo can issue a decision after the hearing at any time.
The Food and Drug Administration first approved mifepristone in 2000. In its lawsuit, the associations say the agency miscalculated its safety and efficacy, and claim it exceeded its regulatory authority by approving the abortion pill.
Mifepristone is the first of a two-drug regimen used to terminate a pregnancy within 10 weeks of pregnancy. In anticipation of an injunction from Kacsmaryk, abortion providers are preparing to offer patients a use-only option misoprostolIt is the second drug approved by the FDA for the prevention and treatment of stomach ulcers.
“They work very well together,” said Melissa Grant, director of operations for carafem, an organization that provides online and in-person abortion services, of mifepristone and misoprostol. She said misoprostol can be used alone when mifepristone is not available, although “it is an operation and people should be willing to invest the time it takes to complete the operation”.
Carafem has been offering medical abortions using only misoprostol since 2020, when the COVID-19 pandemic increased the need for easy access to the abortion pill. At the time, Grant said, more than 80% of Carafem customers chose to use only misoprostol when they chose.
“It became an important option during the pandemic,” she said, and provided the opportunity for the Karafim Group to provide better access to some residents.
The proportion of patients who choose to take misoprostol alone to terminate their pregnancy has dropped to between 10% and 15% after the FDA. Relaxation in personal dispensing requirements In 2021, allowing providers to use telemedicine to prescribe mifepristone and patients to get it by mail.
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Grant predicted that if providers were restricted from providing mifepristone as a result of a court order, more women seeking medical abortion might choose the misoprostol-only option.
Under the two-drug regimen, one mifepristone pill is taken first to block progesterone, which is the hormone necessary for the growth of the pregnancy. Between 24 and 48 hours afterward, the patient takes misoprostol to induce contractions, which is a dose consisting of four tablets that can be dissolved in the mouth or vaginally.
The sequence of two drugs is in between 95% and 99% effective In termination of pregnancy, treatment of medical abortion more than 50% Of all abortions in the United States in 2020, according to the Centers for Disease Control and Prevention. a Stady From the Guttmacher Institute, a pro-abortion research organization, found that 98% of medical abortions in the United States use the combination of mifepristone and misoprostol.
If Kacsmaryk orders the FDA to revoke its approval of mifepristone, the process could take months, and would not mark the end of medical abortion in the United States. Instead, patients can use misoprostol alone, which studies The offer is 80% to 100% effective and it is effective Recommended by World Health Organization as a safe and effective alternative. For misoprostol use only, a total of 12 tablets are taken in three doses every three hours.
“We know there is a slight difference in effectiveness, but it’s still safe and effective,” said Dr. Julie Amaun, medical director at Just The Pill, referring to the use of misoprostol alone. “The biggest thing we’re preparing for is the collective confusion that happens after most of these decisions fall through.”
As with the recent changes in the legal landscape since the Supreme Court Ended the constitutional right to abortion In June 2022, Amaun said her organization is working to prevent outages for her patients.
“We are in the Wild West,” she said. “Everyone is not sure what this ruling could mean.”
With a looming decision by Kacsmaryk, the National Abortion Federation, the professional organization for abortion providers, recently amended Policy guidelines For abortion care to recommend that “where mifepristone is not legally available or inaccessible, misoprostol alone or other evidence-based regimens may be offered.”
“We’re trying to make sure that people understand what’s going on and that medical abortion is still safe and available,” Melissa Fowler, director of programs at the union, told CBS News.
For abortion providers, ensuring that patients are made aware of the effects of the decision about the abortion pill and the options available to them is critical. Caravim staff have been shown how to talk about and taught the misoprostol-only protocol to ensure it is most effective, and the organization has volunteered to help other groups to make sure they understand how the one-drug regimen works.
“Every time a change happens, it can send people at risk into a tailspin, so we think it’s important that we share as much as we can about what the alternative options are,” Grant said.
Just The Pill and Hey Jane, the virtual abortion clinic, are also ready to switch to misoprostol.
Misoprostol suppliers, such as online pharmacies such as Honeybee Health, have assured providers that they are not concerned about meeting a potential surge in demand.
“The judicial system does not regulate drugs, so we need to see the extent of the power [Kacsmaryk] “The FDA approval really should be revoked,” said Kiki Friedman, co-founder and CEO of Hey Jane. I hope it will not come to that and we will do everything we can within legal limits, but we will certainly do everything we can to continue to provide care to our patients.”
Clinics are already grappling with an influx of patients seeking abortions sparked by the Supreme Court’s decision to overturn Roe v. Wade, which paved the way for restrictions or outright bans in more than a dozen states.
“We’ve already overstrained many of the medical buildings that provide abortion care because they’re starting to serve people from restricted states who are traveling,” Grant said.
More disruptions to access to the abortion pill will put more pressure on traditional health centers that provide surgical abortions and on state health care systems, an outcome the US Food and Drug Administration has warned about.
“Excluding patients from the medical abortion option will lead to overcrowding and delays in clinics that provide surgical abortion, including not only abortion clinics but also general practitioners,” the agency told Kasmarek. filing. “This would lead to delays in a range of healthcare services as providers and resources are unnecessarily diverted to surgical abortions.”
Abortion rights groups are also concerned that a legal challenge to the FDA’s approval of mifepristone could have ramifications far beyond the borders of Texas, where the lawsuit was filed, and lead to lawsuits targeting other drugs.
“If he orders the FDA to withdraw its approval, it will affect every state. It will affect places where abortion is protected,” Fowler said. “This condition is larger than miscarriage and has consequences that could affect and undermine the FDA approval process. We don’t want to set a precedent where a small group of people can step in or revoke FDA approval of drugs just because they don’t. I don’t like the drug. It should. To trust science.”
