The future of medical abortion is bogged down in lawsuits over the availability and legality of mifepristone, the first of two drugs used in the procedure.
in late february, Attorneys general from about a dozen states led by Democrats sued the FDA over regulations they say are medically unnecessary and intended to make it more difficult for people to obtain mifepristone. The FDA owns it Some restrictions eased over the past two years, but the mifepristone prescription still holds many qualifiers under the risk assessment mitigation strategy, also known as Reims.
But others claim that the FDA’s rules aren’t strict enough. Whether mifepristone can even survive on the US market could depend on the ruling of a single Texas judge, who has already banned abortion for the state. With narrow exceptionsThe verdict could come any day. In part, the lawsuit alleges that the FDA never had the right to approve mifepristone in the first place, and questions the drug’s safety even though medical organizations continue to support it as safe. If the judge agrees, the case has the potential to ban mifepristone and even change the way medical abortions are performed Countries where abortion is legalalthough a series of Other legal steps and appeals It is expected to follow immediately.
Medication abortion is usually limited to the first trimester of pregnancy and accounts for an increasing number of the total number of abortions in the United States – currently More than half. Medical organizations including the American Medical Association and the American College of Obstetricians and Gynecologists Say that mifepristone is safe. Patients may choose a medical abortion because it is done in the privacy of their own home and can be more accessible or less expensive than the in-clinic procedure. After the US Supreme Court ru flipped. against Wade Last spring, restricting the abortion pill became a priority for lawmakers trying to ban or limit abortion.
Regardless of the judge’s rules in Texas, a flood of appeals and other court moves are expected to follow, making it hard to say for sure what will happen to mifepristone. It’s par for the course after Roe v. Wade, health care providers and legal experts alike say, when the future and legality of drugs used in pregnancy and abortion is left up to government agencies and the courts.
But in the case of Texas, specifically, the FDA’s approval process has been called into question. If a judge revokes the agency’s 20-year seal of approval on a drug, it will be bypassed Calculations of the US Food and Drug Administration regarding the drug’s benefits and risks – And “UnprecedentedMove in the regulation of US drugs, according to an article in the New England Journal of Medicine. Even if mifepristone remains on the market, the case opened the door to the possibility that other drugs and medications could be removed from the market, regardless of the medical condition. The consensus is.
What is mifepristone, and what is the Texas issue?
Mifepristone is a drug used in medicines Abortion in the first trimester As well as early abortion treatments. It temporarily blocks progesterone, a hormone necessary for the maintenance and development of pregnancy. Patients who use it for abortions take it before misoprostol, a medication that causes uterine contractions, to start the end of a pregnancy. Patients who have had a miscarriage He might take it too To help their bodies stop behaving during pregnancy when the pregnancy is no longer viable and the fetus or fetus has stopped developing.
On its own, mifepristone alone is not particularly effective in terminating a pregnancy, which is why it is not Approved by the Food and Drug Administration Specifically for use along with misoprostol, a medication originally intended for stomach ulcers and other health conditions. Misoprostol It is technically used off-label for induced abortion (usually just “miscarriage”) or spontaneous abortion (miscarriage).
Mifepristone has been in the spotlight in abortion discussions because its sole purpose and approval is to terminate pregnancy.
Among the plaintiffs in the Texas case are the Alliance for Hippocratic Medicine, a health care group that is against abortion and socially divisive but medicine-based topics, such as medical-assisted suicide. The lawsuit claims that the US Food and Drug Administration (FDA) never had the authority to approve mifepristone and that it had harmful side effects. the suit It also treats pregnancy as a disease, and the FDA regulates mifepristone as if it were. The actual threat of mifepristone futures market depends on several factors.
Influencing drug regulations at the Food and Drug Administration
Glenn Cohen, a Harvard law professor and faculty director at the school’s Petrie Flom Center for Health Law Policy, said in an email. Cohen is also a signatory to the FDA’s legal researcher friend’s brief for the Texas case, and an author on an article on the case published in the New England Journal of Medicine. An opinion can be more specific and pregnancy-focused, Cohen said, or it can be written broadly. If it is extensive, it is likely to influence judgments of other medications for other health conditions. But it will begin a long process that will involve the Justice Department and other factors, according to Cohen.
Cohen added that nationwide restraining orders that “essentially allow one county court judge anywhere in the country to decide for the entire country” have raised a lot of skepticism, including from Two conservative Supreme Court justices.
If the judge rules in favor of the Alliance for Hippocratic Medicine and revokes the FDA’s 20-plus year seal of approval, this will have crossed the line. FDA benefits vs. risk calculations. For a judge to be able to circumvent this “congressional-created process” in regulating drugs would be unprecedented, Cohen and the other authors write in the article. The scope of the injunction — whether mifepristone is banned nationally — will have to be determined in other courts, and that decision will likely go all the way up to the Supreme Court.
Not only could it change the way the Food and Drug Administration weighs the benefits and risks of drugs, but the courtroom door would be opened to remove other drugs from the market than those used in pregnancy or abortion, including vaccines and Sex confirmation drugs that have been politicized by legislators. And as Reported in slateThe fate of medical abortion also hinges on how much power the FDA retains, and how it uses its discretion in enforcement.
But the Food and Drug Administration is not the final frontier in trying to stop medical abortions. Also in Texas, lawmakers introduced a bill last week aimed at Block websites containing information on medical abortion drugs or sites where people can find pills, which may include third-party pharmacies such as AidAccess. Even in states where abortion is currently prohibited, people can order pills from these websites because they are not regulated by the Food and Drug Administration.
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A medical abortion can continue with only misoprostol
Misoprostol by itself The other recommended method is medical abortionand it may indeed be an adequate regimen for many people in less affluent countries who do not have access to mifepristone.
It is expected that many healthcare providers will continue to prescribe misoprostol for medical abortion where abortion is legal, including online. Monika Siback, Chief Marketing Officer of the Sexual and Reproductive Telemedicine website lock of hairHe said misoprostol would still be available to patients if mifepristone was banned.
And despite the results of the ongoing lawsuits, medical abortion pills will still be available at overseas pharmacies such as AidAccessSurgical abortion will continue to be an option permitted by state laws.
But as studies show misoprostol alone Effective by itself in terminating a pregnancy, it’s not quite as effective as the combination of mifepristone and misoprostol and may cause more pain and side effects, including the need for follow-up care in the emergency room if someone’s body doesn’t go through with the pregnancy, says Dr. Glenmarie Matthews, MD. Obstetrics and Gynecology and Assistant Professor at the Robert Wood Johnson College of Medicine at Rutgers. She says the call to ban mifepristone requires a safe measure and makes it less safe.
Will providers still be comfortable offering misoprostol-only abortions?
“It’s not about being comfortable,” Matthews said. “We still have to have a medical abortion with misoprostol because women still need a medical abortion.”
Even if a judge in Texas doesn’t rule in a way that bans mifepristone nationwide, lawsuits like that still affect abortion because they increase stigma, according to Dr. Jennifer Lincoln, MD, an OB-GYN in Portland, Oregon, and director of Mayday Health.
“It’s just a limitation and adding unnecessary shame and stigma to drugs that have more than 20 years of data that are completely safe,” Lincoln said, adding that the medical abortion pill “sends fewer people to the hospital than Tylenol and Viagra do.”
Matthews says banning medical abortion widens existing gaps in health care access across the United States.
“Of course, people of color and people of low socioeconomic status will again be affected more because they won’t have the resources to get their medication,” Matthews said, referring to the current burden of obtaining misoprostol from pharmacies that may already be reluctant to give misoprostol to pregnant women.
The United States has The highest maternal mortality rate of all rich countries. black women About three times more likely To die during pregnancy, childbirth or the postpartum period.
The information in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified healthcare provider with any questions you may have about a medical condition or health goals.
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