Misoprostol

The U.S. Supreme Court unanimously upheld the availability of mifepristone, rejecting a lawsuit that sought to challenge the FDA's rules for prescribing and dispensing the abortion medication. This decision marks the court’s first major ruling on abortion since conservative justices overturned Roe v. Wade two years ago. The court determined that the plaintiffs, anti-abortion doctors and their groups, lacked the legal standing to challenge the FDA’s approval and regulations of mifepristone. This ruling preserves access to the medication nationwide, including in states where abortion is still legal. Currently, 14 states have total abortion bans, and three others prohibit abortion after about six weeks of pregnancy, often before women know they are pregnant. Justice Brett Kavanaugh, who voted to overturn Roe, wrote in the court’s opinion on mifepristone that “federal courts are the wrong forum for addressing the plaintiffs' concerns about FDA’s actions.” The mifepristone case began soon after the Supreme Court overturned Roe v. Wade, with an initial ruling by a Texas judge to revoke the drug’s approval. The 5th U.S. Circuit Court of Appeals upheld the FDA’s original approval but sought to reverse the relaxed regulations, a move paused by the Supreme Court. In 2016, to enhance accessibility, the FDA updated the drug's REMS program. These revisions extended the maximum gestational age to 70 days, removed the requirement for in-person dispensing, permitted non-doctors to prescribe and administer mifepristone, and stopped the reporting of non-fatal adverse events. After a U.S. District Court Judge in Texas issued a radical ruling in April that suspended the FDA's approval of mifepristone, SCOTUS stepped in, asserting that mifepristone must remain available under the existing rules until the appeals process was complete. In August, the 5th Circuit Court of Appeals in New Orleans decided that while mifepristone should stay legal in the U.S., there should be significant restrictions on patient access, reverting to the 2016 requirements. Just a few weeks ago, the Louisiana House approved a bill adding mifepristone and misoprostol to the state's list of controlled dangerous substances.

THURSDAY, June 13, 2024 -- The U.S. Supreme Court on Thursday threw out a case that aimed to curb access to the controversial abortion drug mifepristone , saying the plaintiffs who brought the case to the court had no legal standing to do so. In a unanimous vote, the nine judges ruled that a group of doctors and other medical professionals -- represented by the conservative Christian legal group Alliance Defending Freedom -- had no legal right to challenge access to the abortion pill and dismissed the case. “Today’s decision from the U.S. Supreme Court provides us with long-awaited relief. We now know that patients and clinicians across the country will continue to have access to mifepristone for medication abortion and miscarriage management," Dr. Stella Dantas , president of the American College of Obstetricians and Gynecologists, said in a statement released after the ruling was issued. "Decades of clinical research have proven mifepristone to be safe and effective, and its strong track record of millions of patient uses confirms that data," she added. At issue in the case were recent U.S. Food and Drug Administration regulatory changes that eased access to mifepristone, one of a two-drug combo (the other being misoprostol) that together induce a medication abortion . The FDA has made it easier to get mifepristone by mail, for example, instead of requiring an in-person visit with a doctor. But the group of doctors behind the case questioned the legality of that move. Other moves by the FDA to increase access to mifepristone included allowing women to obtain the pill within 10 weeks of gestation (instead of seven) and allowing health care providers other than physicians to dispense the pill. All of these regulatory decisions will remain in place following the court's dismissal. "The plaintiffs have sincere legal, moral, ideological and policy objections to elective abortion and to [the] FDA’s relaxed regulation of mifepristone. But under Article III of the Constitution, those kinds of objections alone do not establish a justiciable case or controversy in federal court," the justices wrote. "Here, the plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact. For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions." However, this may not be the end of the fight against mifepristone, since another plaintiff could bring a similar case to the courts at a later date, NBC News reported. The move to force the FDA to back away from its regulatory decisions around mifepristone had implications beyond the abortion debate. As reported by NBC News , the pharmaceutical industry reacted to the case with alarm, noting that it opened the agency up to second-guessing of its approval process by untrained federal judges. That could create uncertainty in the drug industry and undermine research and innovation. Thursday's ruling by the largely conservative court followed a landmark decision in 2022 to overturn Roe v. Wade, which had guaranteed a woman's right to seek an abortion. That decision has led to bans on abortion in 14 states and restrictions in others. In 2023, Texas-based U.S. District Judge Matthew Kacsmaryk issued a ruling invalidating the FDA's approval of mifespristone. But the Supreme Court soon stepped in and put that decision on hold, allowing the pill to remain available to women while the legal fight over access continued. In August, a New Orleans-based court of appeals narrowed Kacsmaryk's ruling but retained his contention that the FDA's decision in 2016 to lift restrictions on mifepristone was illegal. Both sides in the case brought their arguments before the Supreme Court. The judges agreed to hear the Biden administration's defense of later FDA decisions around mifepristone access, but they rejected a hearing on any challenge to the drug's original approval in 2000. According to NBC News , other hot-button abortion litigation is currently before the Supreme Court. The justices are due to decide on an Idaho case involving the right of emergency room physicians to conduct an abortion when a pregnant woman brought to the ER is facing dangerous complications. Idaho's strict anti-abortion laws ban such action at present. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.