Misoprostol

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.

The Supreme Court on Thursday unanimously ruled an anti-abortion group contesting the Food and Drug Administrations approval of the abortion pill mifepristone does not have a legal basis to sue, putting an end to a high-profile court battle.Justices held that the plaintiffs desire to make a drug less available to others did not give them standing to challenge the FDAs actions around mifepristone.The plaintiffs have failed to demonstrate that FDAs relaxed regulatory requirements likely would cause them to suffer an injury in fact, Justice Brett Kavanaugh wrote in the courts opinion. For that reason, the federal courts are the wrong forum for addressing the plaintiffs concerns about FDAs actions.The Supreme Courts decision reverses a lower court ruling that would have limited mifepristones availability, and allows access to the drug to remain as it is. That includes recent changes made by the FDA to permit prescriptions via mail and use through 10 weeks of pregnancy.Abortion still remains banned in states where legislatures have enacted laws following Roe v. Wades reversal. And as the Supreme Court decided the case on the basis of standing, it didnt delve into debates over how the FDA has regulated the drugs use.Mifepristone has been approved in the U.S. since 2000, but its place on the market came under threat when the Alliance for Hippocratic Medicine sued the FDA in 2022. The groups case, which was first heard in a Texas district court, came less than one year after the Supreme Court overturned Roe v. Wade, the landmark 1973 verdict that had granted the constitutional right to an abortion.Mifepristone is typically taken in combination with another drug called misoprostol for medication abortions. In the two decades since mifepristones initial approval, studies have shown it to be safe and effective. Medication abortions have for years accounted for a large share of the abortions conducted in the U.S. a share that has grown to more than 60% since Roe v. Wade was reversed.But the Alliances challenge, and initial rulings at the district court and appeals court level, put access to mifepristone in jeopardy. They also raised the possibility of judicial intervention in the FDAs scientific decision-making. Biotechnology industry leaders were outspoken about the risks to drug regulation posed by the case, citing concerns of a precedent for the legal revocation of a drug approval.Those fears now appear unfounded, as the Supreme Court rejected the plaintiffs arguments the FDAs actions had harmed them.The ruling reflected skepticism justices voiced in March, when the high court heard oral arguments from the Alliance, the Biden Administration and abortion pill manufacturer Danco Laboratories. Then, the Alliance had argued against FDA decisions to expand the drugs approval between 2016 and 2021. Lawyers for the group claimed there was a subsequent increase in emergency room visits, and cited possible harm to doctors who object to abortion but might be required to treat complications from mifepristone use.Justices, however, were skeptical, citing existing legal protections for doctors. Federal law fully protects doctors against being required to provide abortions or other medical treatment against their consciences and therefore breaks any chain of causation between FDAs relaxed regulation of mifepristone and any asserted conscience injuries to the doctors, Kavanaugh wrote in Thursdays opinion.The legal battle over mifepristone began when the Alliance sued the FDA for wrongfully approving the medication. Conservative U.S. District Court Judge Matthew Kacsmaryk, who first heard the case, ruled to invalidate the FDAs approval, sparking appeals and counter-rulings. Soon after Kacsmaryks verdict, a judge in Washington ordered the FDA to maintain the pills status in 17 Democratic-led states that had sought broader access, for example.After an appeal from Danco and the Biden administration, the U.S. Court of Appeals for the 5th Circuit partially blocked Kacsmaryks decision, determining the Alliances challenge came too late to overturn the FDAs 2000 approval of mifepristone. But the court rolled back the expansions to the drugs labeling granted by the FDA. The FDA and Danco appealed, sending the case to the Supreme Court, which put the lower courts decision on temporary hold while it deliberated.The decision Thursday now reverses the 5th Circuits ruling. Justice Clarence Thomas wrote a concurring opinion to Kavanaughs. '