Latest news with #mifepristone
New York Times
09-06-2025
- Health
- New York Times
A Day With One Abortion Pill Prescriber
The young woman's voice trembled over the phone. Sitting in her car in Alabama, where abortion is almost totally banned, the 26-year-old mother of two was grappling with an unintended pregnancy. 'I'm like 'How in the world?'' she said, stifling a sob. 'I already have two children, and I cannot. I can't. I just can't go through with it.' She wanted an abortion, she said, but was afraid of getting caught and didn't know what to expect from the process. 'Growing up, I never really thought about actually doing something like this,' she said. On the other end of the line, at home on a quiet residential street in Delaware, Debra Lynch, a nurse practitioner who runs a service prescribing abortion pills, spoke calmly. 'It's completely valid to be scared,' she said from her desk in a home office filled with plants and shelves of medication. 'And that's why we want you to call us, even if you're calling just to say: 'I'm scared. I need to hear somebody tell me that what's going on right now is normal, and it's OK.'' During the 25-minute conversation, Ms. Lynch asked the woman about her health history and pregnancy and assessed that she was medically eligible for abortion medications that can be taken in the first 12 weeks of pregnancy: mifepristone, which blocks a hormone necessary for pregnancy development, and misoprostol, taken 24 to 48 hours later, which causes contractions so pregnancy tissue can be expelled. Want all of The Times? Subscribe.
Yahoo
08-06-2025
- Health
- Yahoo
AG pushes back on federal abortion medication restrictions
BOSTON (SHNS) – Attorney General Andrea Campbell implored federal regulators Thursday to eliminate medication abortion restrictions on prescribers and pharmacies, arguing Massachusetts already has 'robust' guardrails in place to protect patient safety. Campbell, along with AGs from California, New York and New Jersey, want the U.S. Food and Drug Administration to eliminate its Risk Evaluation and Mitigation Strategy (REMS) program for mifepristone — or at least stop applying certain parts of it to the four petitioning states. The program outlines certification requirements for health care providers and pharmacies to dispense mifepristone, plus paperwork that patients must sign. About 65% of abortions in Massachusetts in 2023 were medication abortions, according to the 64-page citizen petition Campbell co-filed Thursday. The FDA says REMS programs are used for drugs with 'serious safety concerns to help ensure the benefits of the medication outweigh its risks.' Campbell's office contends the mifepristone requirements impose 'burdensome restrictions on access to medication abortion while not meaningfully improving patient safety, and that these restrictions severely impede patient access by reducing the number of prescribers and pharmacies authorized to dispense this FDA-approved medication.' 'The Mifepristone REMS Program also imposes an undue burden on pregnant patients experiencing miscarriage and early pregnancy loss who seek treatment at emergency departments,' the petition says. 'For instance, the administrative requirements imposed by the REMS can effectively discourage emergency departments from carrying mifepristone in their pharmacies.' Reduced access to mifepristone can particularly impact patients in rural and medically underserved areas, the petition added. The Democratic AGs teamed up in response to U.S. Health and Human Services Secretary Robert Kennedy recently instructing FDA Commissioner Martin Makary to pursue a 'complete review' of mifepristone and labeling requirements. The FDA is required to respond to their petition within 180 days by either approving, denying or dismissing it — or providing a 'tentative response' about why the agency is unable to reach a decision yet, according to federal regulations. In response to the Trump administration, Beacon Hill lawmakers are escalating their focus on shoring up protections for reproductive and transgender care. A Sen. Cindy Friedman bill (S 2522) that's gaining traction would tighten the 2022 abortion shield law, including by requiring hospitals to provide emergency abortion care and allowing provider practices, rather than specific prescriber names, to appear on medication abortion labels. WWLP-22News, an NBC affiliate, began broadcasting in March 1953 to provide local news, network, syndicated, and local programming to western Massachusetts. Watch the 22News Digital Edition weekdays at 4 p.m. on Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Gizmodo
06-06-2025
- Health
- Gizmodo
Four Democrat-Led States Ask FDA to Lift Restrictions on Abortion Pill
The attorneys general of four Democrat-led states—New York, New Jersey, Massachusetts, and California—petitioned the Food and Drug Administration on Thursday, June 5, asking the agency to lift what they view as unnecessary restrictions on the abortion pill mifepristone. The petition aims to force the FDA to acknowledge robust clinical evidence and decades of mifepristone use that support the drug's safety and efficacy. The move comes just one month after Health and Human Services Secretary Robert F. Kennedy Jr. told Congress that he ordered a safety review of the abortion pill. An FDA spokesperson confirmed plans for the review in a statement to CBS News on Tuesday, June 3. According to the FDA, mifepristone, approved by the regulator in 2000, is a drug that blocks the hormone progesterone, which is necessary for pregnancy to continue. It is most commonly used in combination with the drug misoprostol to terminate a pregnancy within 10 weeks of gestation. An analysis of 2023 data by the Guttmacher Institute found that medication abortions account for more than half (63%) of all abortions in the U.S. But in the years since the Supreme Court overturned Roe v. Wade, 17 states have banned this medication, and an additional 10 states have placed restrictions on it, according to the Washington Post. 'The medication is a lifeline for millions of women who need access to time-sensitive, critical healthcare—especially low-income women and those who live in rural and underserved areas,' California attorney general Rob Bonta told the Los Angeles Times. The petition specifically asks the FDA to lift the mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program. This additional regulatory framework is designed to 'help ensure the benefits of the medication outweigh its risks,' according to the FDA. REMS has been applied to 325 medications since its inception and currently applies to 71 drugs. REMS places multiple restrictions on mifepristone use, including that prescribers be put on national and local abortion provider lists; patients give written statements that they intend to end their pregnancies; and pharmacies keep records of mifepristone prescribers and users. The attorneys general argue that these rules 'impose unnecessary and burdensome hurdles on patients, prescribers, pharmacists, and the healthcare system.' They also point out that mifepristone has been marketed in the U.S. for decades and has been safely used by more than 7.5 million American women. 'Moreover, no new evidence raising safety concerns has emerged in the last two decades,' they state. These states are not alone in their pursuit of expanded mifepristone access. Seventeen other Democratic-led or -leaning states, plus Washington D.C., are suing the FDA in Spokane, Washington, to loosen restrictions on the drug, Reuters reported in February. What's more, leading medical organizations have called on the FDA to remove REMS restrictions on mifepristone for years. If the FDA declines to remove REMS, Thursday's petition asks the agency to 'exercise its discretion not to enforce' some or all of the restrictions in New York, New Jersey, Massachusetts, and California, as these states already place 'rigorous restrictions' around the practice of medicine.
Reuters
05-06-2025
- Business
- Reuters
Four Democratic-led US states urge FDA to remove abortion pill restrictions
NEW YORK, June 5 (Reuters) - The attorneys general of New York, California, Massachusetts and New Jersey asked the Food and Drug Administration to expand access to the abortion pill mifepristone, and remove what they view as outdated and medically unnecessary restrictions. Thursday's petition by the Democratic-led states seeks to force the FDA to acknowledge what the states view as "extensive" evidence that mifepristone is safe, notwithstanding the Trump administration's general opposition to abortion. It came after Health and Human Services Secretary Robert F. Kennedy Jr told Congress last month he ordered FDA Commissioner Marty Makary to review the pill, and unspecified "alarming" new data suggested the government should at least change the label. 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. Medication abortions account for more than half of U.S. abortions, though 28 states restrict access, according to the nonprofit Guttmacher Institute, which focuses on reproductive health. The petition challenges FDA requirements that mifepristone prescribers be included in national and local abortion provider lists, patients attest in writing that they intend to end their pregnancies, and pharmacies perform a variety of recordkeeping. Citing the drug's safety record, it said those rules, part of the FDA's Risk Evaluation and Mitigation Strategy program, are "no longer justified by science or law," especially in states where abortion is legal and comprehensively regulated. New York Attorney General Letitia James said the rules keep mifepristone out of reach of most primary care settings. She called that problem particularly acute in rural and other areas where getting abortions often requires lengthy travel. "There is simply no scientific or medical reason to subject it to such extraordinary restrictions," James said, referring to mifepristone. "The FDA must follow the science." A spokeswoman for the Department of Health and Human Services said FDA Commissioner Makary "will ensure gold standard science is used while incorporating practical, common-sense considerations to its regulatory processes." Many states, primarily Republican-led or leaning, have restricted or substantially eliminated abortions in the three years since the U.S. Supreme Court overturned Roe v. Wade, the 1973 decision that legalized the procedure nationwide. Last June, the Supreme Court preserved broad access to mifepristone, unanimously ruling that a group of anti-abortion organizations and doctors lacked legal standing to challenge the FDA's approval of the pill. Despite largely siding with abortion opponents, Republican President Donald Trump said during his 2024 campaign he did not plan to limit access to mifepristone. Last month, the administration asked a federal judge to dismiss, on procedural grounds, a lawsuit by three generally Republican states seeking to narrow such access. That lawsuit began during the administration of Democratic President Joe Biden, who generally supported abortion access. Seventeen other Democratic-led or -leaning states plus Washington, D.C., are separately suing the FDA in Spokane, Washington, to loosen restrictions on mifepristone. They said doctors and pharmacies should be able to dispense the pill, as with most drugs, without special certifications. On May 30, the Trump administration urged a dismissal, saying the states didn't show the FDA's policy was flawed or the agency ignored important evidence. The states filed Thursday's petition after a short delay, with the filing having been expected earlier in the morning.
Washington Post
05-06-2025
- Health
- Washington Post
Four Democrat-led states ask FDA to remove abortion pill restrictions
Four blue states are asking the U.S. Food and Drug Administration to remove restrictions on a key abortion medication and make it easier for clinicians to prescribe and dispense it — an attempt to widen access as the agency plans to review the pill's safety. The Democratic attorneys general of California, New York, Massachusetts and New Jersey filed a petition Thursday asking the FDA to remove stringent regulations on access to mifepristone, saying they are 'medically unnecessary' for a drug that scientific studies have shown is safe. The drug is taken alongside misoprostol to end pregnancies through 10 weeks' gestation and treat early miscarriages.
