Latest news with #Mifepristone
The Hindu
17-07-2025
- Health
- The Hindu
Show cause notice to 149 medical shops in Telangana for illegal sale of abortion kits
The Telangana Drugs Control Administration (DCA) conducted a special inspection drive on Wednesday (July 16, 2025) to curb the illegal sale of abortion kits across medical shops. The inspections, held simultaneously in multiple districts, targeted unauthorised sale of Schedule-H drugs such as Mifepristone and Misoprostol tablets, commonly used in medical terminations of pregnancy. The drive, aimed at ensuring compliance with the Drugs and Cosmetics Act, 1940, and associated rules, revealed serious violations in 149 medical shops. Show Cause notices were issued to these outlets, paving the way for departmental action, officials said. According to the DCA, the officers detected a range of violations during the inspections. These included selling abortion kits without a valid prescription, dispensing drugs in the absence of a licensed pharmacist, and failing to issue or maintain sales and purchase bills. Other lapses included the non-maintenance of prescription registers and irregularities in the documentation of stock records and invoices. 'Abortifacient drugs are powerful medications that should only be used under strict medical supervision. Their misuse can have life-threatening consequences. These inspections are part of our effort to ensure public safety and uphold the law,' said a release.
Time of India
16-07-2025
- Health
- Time of India
West Virginia ban on abortion medication upheld
A divided federal appeals court on Tuesday upheld West Virginia's near-total ban on abortion, including limits on the widely used medication abortion drug mifepristone. The 4th U.S. Circuit Court of Appeals in Richmond, Virginia, said the Food and Drug Administration's approval of mifepristone did not preempt West Virginia's law as applied to medication abortions, which account for more than half of U.S. abortions. Circuit Judge J. Harvie Wilkinson said a 2007 federal law giving the FDA more authority over "high-risk" drugs did not evince a clear intention to displace states' traditional right to protect their citizens' health and safety. Wilkinson also found no indication that Congress intended to guarantee nationwide access to mifepristone. "The debate joined by able and dedicated supporters and opponents of access to abortion medications is simply not one, in the absence of clear congressional direction, for this court to decide," the judge wrote. Tuesday's 2-1 decision is the first by a federal appeals court to say states can restrict use of the pill. In June 2024, the U.S. Supreme Court preserved access to mifepristone, rejecting an effort by anti-abortion doctors and groups to roll back FDA approval. West Virginia's law had been challenged by GenBioPro, a Nevada company that sells a generic version of mifepristone. Opponents said letting the law stand could allow other states to criminalize access to federally approved medications. The law "sets a dangerous precedent regarding access to other evidence-based health care that (the) FDA has deemed safe and effective," said Skye Perryman, president of the nonprofit Democracy Forward, which helped represent GenBioPro. Erin Hawley, a lawyer representing West Virginia, said the court "rightly refused GenBioPro's invitation to federalize the issue of abortion." Hawley is senior counsel at the nonprofit Alliance Defending Freedom, which also brought the Supreme Court mifepristone case. Governor Patrick Morrisey , a Republican who defended West Virginia's law as that state's attorney general, called the decision a "big win" that lets West Virginia "lead the nation in our efforts to protect life." DISREGARDING SUPREME COURT 'NOT AN OPTION' Mifepristone is the first pill, followed by the drug misoprostol, for medication abortion in the first 10 weeks of pregnancy, and won FDA approval in 2000. Twenty-eight states restrict access to medication abortions, according to the nonprofit Guttmacher Institute, which focuses on reproductive health. West Virginia's Unborn Child Protection Act banned abortion with narrow exceptions, including within the first 14 weeks of pregnancy for minors who are victims of rape and incest. Without opining on the law, Wilkinson said federal courts shouldn't substitute their policy preferences for those of state legislators. He also said voiding the law would amount to near "defiance" of Dobbs v. Jackson Women's Health Organization , the 2022 Supreme Court decision that eliminated the federal constitutional right to abortion. "Just after the Supreme Court restored the states' traditional authority to regulate abortion, GenBioPro would have us wrest it right back," Wilkinson wrote. "At a time when the rule of law is under blunt assault, disregarding the Supreme Court is not an option," he added. Wilkinson was appointed to the bench by Republican President Ronald Reagan. His opinion was joined by U.S. District Judge Rossie Alston, an appointee of Republican President Donald Trump who normally sits in Alexandria, Virginia. Circuit Judge DeAndrea Gist Benjamin, an appointee of Democratic President Joe Biden, dissented, saying West Virginia's law "erects barriers to life-saving healthcare for countless West Virginians in ways not envisioned by Congress." She also said the law could unduly burden patients in medically underserved areas elsewhere by forcing West Virginians to travel to other states for treatment. Tuesday's decision upheld an August 2023 ruling by U.S. District Judge Robert Chambers in Huntington, West Virginia.
The Hill
25-06-2025
- Health
- The Hill
The FDA's ‘data guy' should trust the data on the abortion pill
At a time when abortion access is under attack, Food and Drug Administration Commissioner Marty Makary's pledge to reexamine the safety of medication abortion isn't just pointless — it's dangerous. While the FDA has yet to announce when this review will take place or what it will entail, it's clear that Makary's decision is part of a strategy to stoke fear and distrust of abortion pills and further prevent patients from making their own decisions about their health. Mifepristone, the abortion pill, is one of the most studied drugs on the market. Since its approval 25 years ago, 7.5 million patients across the country have used it safely. Study after study shows that it is effective and low-risk and can be life-saving. This is not an abstract debate for us. One of us is a public health scientist who has spent two decades studying the safety and accessibility of abortion, leading large-scale studies that have shaped national conversations and informed policy. The other runs a telemedicine clinic that has provided medication abortion by mail after an online consultation to tens of thousands of patients across the country, many of whom would otherwise face long travel, high costs, delayed abortion or no options at all. Together, we bring both data and lived experience to this issue. We don't just know the research — we see the real-life consequences of abortion policy every day. When the FDA approved mifepristone in 2000, it tacked on restrictions widely acknowledged as politically motivated, not medically necessary. Only doctors could prescribe it, and patients had to pick it up in person at a clinic or hospital — no pharmacies, no mail. These hurdles had little to do with safety and everything to do with stigma and paternalism. After two decades of peer-reviewed research and clinical experience, the FDA rolled back those restrictions, paving the way for those seeking an abortion across the country to access care via virtual telehealth services. Today, medication abortion is the most common method of abortion in the U.S., accounting for more than 63 percent of abortions. In 2024, the University of California San Francisco led a landmark study that found this model is not only as effective and low-risk as in-person medication abortion care, but critical for expanding access. It reduces stigma and allows people to get care affordably and privately, and without the burden of travel. Access is everything. For young people, rural communities and those struggling to make ends meet, telehealth can be the difference between getting care or not. Since the fall of Roe v. Wade, states where abortion is still legal have seen surging demand. Telehealth helps meet that need, reducing wait times and letting people get care earlier in pregnancy. In fact, a newly released report states that one in four abortions in the U.S. happens via telehealth. Medication abortion is safe. Yet after more than two decades of following the science and expanding access to mifepristone, the FDA is suddenly casting doubt on it. Makary, who proudly calls himself a 'data guy,' should have no trouble acknowledging that the science behind mifepristone is rock solid — and it hasn't changed. In fact, Makary's own agency released a new report on adverse events for mifepristone less than six months ago, proving the drug's exceptional track record yet again, including when it is dispensed through telehealth. Decades of peer-reviewed research prove this medication is not just safe but safer than most prescription drugs and even many over-the-counter ones. Millions of Americans have relied on medication abortion to make deeply personal decisions about their own bodies — and that reality isn't going anywhere. We don't need another round of endless reviews. The evidence for medication abortion's safety is overwhelming and crystal clear. The FDA's job is simple: follow the science, not second-guess it. Anything less will risk standing in the way of Americans' health and well-being. Ushma Upadhyay, Ph.D., MPH is a professor at the University of California, San Francisco in the Department of Obstetrics, Gynecology, and Reproductive Sciences. Kiki Freedman is co-founder and CEO of Hey Jane.
Yahoo
23-06-2025
- Health
- Yahoo
Mifepristone Shown to Reduce A1C in Patients with Difficult-to-Control Type 2 Diabetes and Hypercortisolism
Study Results Signal Paradigm Shift in Diabetes Care for Patients with Difficult-to-Control Type 2 Diabetes CHICAGO, June 23, 2025 /PRNewswire/ -- New findings from the CATALYST study show that the use of mifepristone resulted in improved blood glucose (blood sugar) control and weight reduction in patients with difficult-to-control type 2 diabetes and hypercortisolism. The results of the largest prospective trial of its kind were presented as a late-breaking symposium at the 85th Scientific Sessions of the American Diabetes Association® (ADA) in Chicago, and simultaneously published in Diabetes Care®. Among patients with type 2 diabetes, more than half do not achieve blood glucose targets as assessed by the hemoglobin A1C test, despite substantial lifestyle efforts and multiple medications. The CATALYST study explored whether hypercortisolism is a contributing factor in people with difficulty achieving A1C targets despite multiple medications. Hypercortisolism is a condition where the body produces too much cortisol, which can raise blood glucose. Part 1 of the CATALYST study, presented at the 84th Scientific Sessions, revealed that hypercortisolism may be a significant contributing factor in one in four patients with difficult-to-control diabetes. Patients with hypercortisolism presenting as uncontrolled type 2 diabetes physically appear the same as those without hypercortisolism, but they do seem to require more medications and have more complications. Part 2 of the CATALYST study was a randomized, prospective, placebo-controlled, double-blind multi-center trial designed to assess the safety and efficacy of mifepristone treatment in patients with hypercortisolism who have difficult-to-control type 2 diabetes. 136 participants with hypercortisolism received either mifepristone or placebo over a 24-week period to assess the impact on glycemic control and other metabolic parameters. Mifepristone is a medication that reduces the effects of cortisol and is FDA approved for the treatment of elevated blood glucose in patients with hypercortisolism and prediabetes or type 2 diabetes. Mifepristone reduced A1C by 1.5% as compared to a reduction of 0.2% with placebo. The A1C reductions occurred even as many patients decreased or stopped other diabetes medications, including insulin. In addition, treatment of hypercortisolism with mifepristone was associated with nearly 10 pounds of weight loss and a reduction in waist circumference of more than two inches. "These findings demonstrate a potentially promising treatment solution for patients with difficult-to-treat type 2 diabetes and hypercortisolism, a patient population frustrated with poor results of their diabetes care," said John Buse, MD, PhD, from the University of North Carolina School of Medicine and one of the authors of the study. "By treating the root cause—excess cortisol—we saw meaningful improvements in both blood glucose and weight which could be game changing when it comes to managing type 2 diabetes." The authors note that results may translate to expanded screening for hypercortisolism in patients with type 2 diabetes. Future research is needed to understand whether patients with less advanced type 2 diabetes may experience similar benefits, if other cortisol-directed therapies offer similar results, and whether long-term treatment will provide benefits in preventing complications associated with inadequately controlled type 2 diabetes. Research presentation details:Dr. Buse will present the findings at the following symposium along with Drs. Ralph DeFronzo, Vanita Aroda, and Vivian Fonseca: Symposium: Treatment of Hypercortisolism in People with Difficult-to-Control Type 2 Diabetes—Final Results of the CATALYST Trial Presented on Monday, June 23 at 3:15 p.m. CT About the ADA's Scientific SessionsThe ADA's 85th Scientific Sessions, the world's largest scientific meeting focused on diabetes research, prevention, and care, will be held in Chicago, IL on June 20-23. Thousands of leading physicians, scientists, and health care professionals from around the world are expected to convene both in person and virtually to unveil cutting-edge research, treatment recommendations, and advances toward a cure for diabetes. Attendees will receive exclusive access to thousands of original research presentations and take part in provocative and engaging exchanges with leading diabetes experts. Join the Scientific Sessions conversation on social media using #ADASciSessions. About the American Diabetes Association The American Diabetes Association (ADA) is the nation's leading voluntary health organization fighting to end diabetes and helping people thrive. This year, the ADA celebrates 85 years of driving discovery and research to prevent, manage, treat, and ultimately cure—and we're not stopping. There are 136 million Americans living with diabetes or prediabetes. Through advocacy, program development, and education, we're fighting for them all. To learn more or to get involved, visit us at or call 1-800-DIABETES (800-342-2383). Join us in the fight on Facebook (American Diabetes Association), Spanish Facebook (Asociación Americana de la Diabetes), LinkedIn (American Diabetes Association), and Instagram (@AmDiabetesAssn). To learn more about how we are advocating for everyone affected by diabetes, visit us on X (@AmDiabetesAssn). Media Contact: MCarmody@ View original content to download multimedia: SOURCE American Diabetes Association
Yahoo
11-06-2025
- Health
- Yahoo
Montana Supreme Court strikes down trio of abortion bills as unconstitutional
In this photo illustration, packages of Mifepristone tablets are displayed at a family planning clinic on April 13, 2023 in Rockville, Maryland. A Massachusetts appeals court temporarily blocked a Texas-based federal judge's ruling that suspended the FDA's approval of the abortion drug Mifepristone, which is part of a two-drug regimen to induce an abortion in the first trimester of pregnancy in combination with the drug Misoprostol. (Photo illustration by) A trio of abortion-related bills, passed in 2021, were declared unconstitutional by a nearly unanimous Montana Supreme Court on Monday. Nearly, because Justice Jim Rice wrote both a concurring and dissenting opinion affirming again Montana's constitutionally protected right-to-privacy, which includes medical procedures and abortion. The laws were halted before they could even be practically enacted, so the hurdles to the procedure, including waiting periods, mandatory ultrasound, a pile of documentation and banning abortion after 20 weeks, even before the point of fetal viability, never rippled throughout the state. Justice Beth Baker wrote the opinion on behalf of the court, which not only reaffirmed the state Constitution's right-to-privacy as unique and separate from federal cases on abortion, but also took the state to task for failing to support its claim that the State of Montana had a compelling interest in abortion, while not proving that any of the legislative hurdles were scientifically supported. The lawsuit was brought by Planned Parenthood of Montana, and had a handful of other entities that wrote friends-of-the-court briefs, including a group of delegates to the 1972 Montana Constitutional Convention. The three laws that were challenged were House Bill 136, House Bill 140 and House Bill 171: HB 136 would have banned abortion at 20 weeks, even though expert opinion agreed that fetal viability is not possible until at least 22 weeks. HB 171 would have put paperwork and more requirements for healthcare providers who provide abortion via medication or telehealth, subjecting them to both civil and criminal penalties. HB 180 would have required healthcare professionals to provide both ultrasound and fetal heartbeat tones to those considering abortion, and requiring a patient to sign a form created by the state, demonstrating that the patient had been offered the choice, and yet declined. Because fetal viability — or the concept a child can survive outside the womb — is dictated by a host of factors, including medical science and approximate age of the fetus, the court rejected the state's attempts to prescribe a fixed number of weeks for viability. 'A fixed gestational age that does not allow a provider's case-specific determination fails to ensure that the government does not interfere with an individual's private medical decision,' the ruling said. 'Until a fetus is viable and able to survive outside the womb, the right of personal autonomy belongs to the person on whose body the fetus depends. 'We find no legal authority for the idea that the state's interest in preserving fetal life or the fetus' right to life takes precedence over all constitutional protections and dignities of the mother.' Attorneys for the state had argued that physical safety risks of abortion increase as the pregnancy progresses, and that abortions lead to worse mental health outcomes, an argument that the Supreme Court dismissed and debunked. 'The record shows that abortion is safe,' the decision said. 'As the district court noted, there were zero deaths cause by abortion in Montana between 2010 and 2020 and only 25 of 8,402 (0.3%) reported abortions in Montana from 2016 to 2021 resulted in complications. This court cannot find a bona fide health risk simply based on a detailed step-by-step description of what the state defines as 'barbaric' and 'gruesome' procedure when the overwhelming evidence shows that procedural abortions are safe.' The ruling also said if the state wanted to address health outcomes or mental health issues, banning abortion was not the least restrictive way to do it. The court also pointed out waiting-periods and requiring multiple in-person visits, as outlined by HB 171, actually increased the odds of harm or complications, instead of avoiding them. 'The record demonstrates that compliance with the 24-hour wait period, the multiple in-person visits, and the telehealth ban serve only to delay access to abortion care — thus increasing the odds that the patient will not be able to obtain an abortion or increasing the odds of the very complications this state asserts it wishes to protect against,' the opinion said. The ruling also said in addition to violating the state's constitutional provisions for privacy, it also impacted physician's free-speech rights by requiring them to provide forms and documents, for example, information about a disputed abortion reversal procedure, that have not been medically verified or supported. They said HB 171 compelled healthcare professionals to give advice contrary to their training and conscience. Physicians and experts also raised concerns about the state's assertion abortion led to other health care concerns, for example, an increase in breast cancer, which has never been scientifically established. 'Forcing medical providers to give medical advice that they disagree with — like the safety and efficacy of abortion reversal — is a form of compelled-speech triggering protections,' the ruling said. '(Planned Parenthood) asserts that patients may mistakenly understand the consent form to indicate DPHHS's and their provider's approval of abortion reversal.' The ruling calls such compelled speech egregious because it 'favors one viewpoint over another — namely, the viewpoint that abortion reversal is safe and possible over the judgements and viewpoints of providers that it is unsafe, ineffective and undermines informed consent.' The court noted the state does not mandate documentation or consent that requires medical providers to discuss the risk of carrying a pregnancy to term. Finally, the court also called into question the real purpose of HB 140, which mandates ultrasounds and fetal heart tones before an abortion, something that providers said either happens during the course of pregnancy, but may not be medically necessary. 'The court stated it was 'left with the strong impression that the law aims to advance the ulterior motive of discouraging abortion,' which is unacceptable under the law,' the ruling said. Montana's highest court found that in the case of HB 140, it was exactly substituting the judgment of the state, and the lawmakers who supported it, with the views of the doctor. 'The court's decision further protects what Montanans need and deserve: Legal access to compassionate, timely abortion care, free from government interference. At the same moment as this win for Montanans, anti-abortion politicians continue to threaten to decimate access to care by 'defunding' Planned Parenthood via the reconciliation bill before Congress, in an effort to shut down health centers who provide abortion and other reproductive care. Montanans agree that abortion should remain legal and accessible, and Planned Parenthood of Montana will always do whatever we can to ensure that patients in Montana have access to abortion care,' said Martha Fuller, president and CEO of Montana Planned Parenthood, after the ruling in a statement. The case was active for several years of litigation, and had district court Judge Amy Eddy sitting in place of former Chief Justice Mike McGrath, who retired at the end of 2024, as well as Judge Shane Vannatta, who was sitting in for Dirk Sandefur, who also retired. McGrath has since been replaced by Chief Justice Cory Swanson, and Sandefur was succeeded by Justice Katherine Bidegaray.
