Latest news with #RiskEvaluationandMitigationStrategy
Yahoo
a day ago
- Health
- Yahoo
Blue states call on FDA to expand abortion pill access
Attorneys general of New York, California, New Jersey and Massachusetts are asking the Food and Drug Administration (FDA) to expand access to the abortion pill and remove some 'unnecessary' drug restrictions that have been in place for more than two decades. The joint petition, filed Thursday, comes days after FDA Commissioner Marty Makary committed to reviewing the abortion drug amid pressure from Department of Health and Human Services Secretary Robert F. Kennedy Jr. and some Republican lawmakers. The FDA first approved of the use of mifepristone and misoprostol for an abortion in 2000. Unlike surgical abortions, medication abortions do not need to take place in a clinical setting, and patients are able to take the pills at home. Most abortions in the U.S. are now medication abortions, according to data from the reproductive health and rights group Guttmacher Institute. In 2023, 63 percent of all abortions in the U.S. were medication abortions. The safety of mifepristone has come under increased scrutiny by some Republican lawmakers, citing a flawed study claiming the rate of adverse health events that occur among patients is far higher than previously reported. More than 100 scientific studies have been conducted looking at the safety and efficacy of mifepristone and misoprostol; all of them have found that the drugs are a safe way to terminate a pregnancy. 'Given Mifepristone's 25-year safety record, there is simply no scientific or medical reason to subject it to such extraordinary restrictions,' New York Attorney General Letitia James said. 'The FDA must follow the science and lift these unnecessary barriers that put patients at risk and push providers out of care.' Mifepristone's use is subject to a Risk Evaluation and Mitigation Strategy (REMS) program under the FDA. The attorneys general argue three requirements under the REMS program for the drug should be removed since they pose a burden to patients and health care systems. The first is related to prescriber certification. As part of the REMS program, health care providers who prescribe mifepristone are required to add their names to national and abortion provider lists, which the attorneys general say raise 'serious safety and legal concerns.' The second has to do with patient agreement forms. All patients who want mifepristone — even those using the drug to treat a miscarriage — are required to sign a document stating they are using the drug to end a pregnancy. The third requirement mentioned in the petition is connected to pharmacy certification. As part of mifepristone's REMS program, pharmacies that carry the drug are subject to tracking, shipping and reporting requirements, which the attorneys general argue may 'dissuade' some from carrying the drug. The FDA has yet to reply to a request for comment from The Hill about the petition. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
The Hill
a day ago
- Health
- The Hill
Blue states call on FDA to expand abortion pill access
Attorneys general of New York, California, New Jersey and Massachusetts are asking the Food and Drug Administration (FDA) to expand access to the abortion pill and remove some 'unnecessary' drug restrictions that have been in place for more than two decades. The joint petition, filed Thursday, comes days after FDA Commissioner Marty Makary committed to reviewing the abortion drug amid pressure from Department of Health and Human Services Secretary Robert F. Kennedy Jr. and some Republican lawmakers. The FDA first approved of the use of mifepristone and misoprostol for an abortion in 2000. Unlike surgical abortions, medication abortions do not need to take place in a clinical setting, and patients are able to take the pills at home. Most abortions in the U.S. are now medication abortions, according to data from the reproductive health and rights group Guttmacher Institute. In 2023, 63 percent of all abortions in the U.S. were medication abortions. The safety of mifepristone has come under increased scrutiny by some Republican lawmakers, citing a flawed study claiming the rate of adverse health events that occur among patients is far higher than previously reported. More than 100 scientific studies have been conducted looking at the safety and efficacy of mifepristone and misoprostol; all of them have found that the drugs are a safe way to terminate a pregnancy. 'Given Mifepristone's 25-year safety record, there is simply no scientific or medical reason to subject it to such extraordinary restrictions,' New York Attorney General Letitia James said. 'The FDA must follow the science and lift these unnecessary barriers that put patients at risk and push providers out of care.' Mifepristone's use is subject to a Risk Evaluation and Mitigation Strategy (REMS) program under the FDA. The attorneys general argue three requirements under the REMS program for the drug should be removed since they pose a burden to patients and health care systems. The first is related to prescriber certification. As part of the REMS program, health care providers who prescribe mifepristone are required to add their names to national and abortion provider lists, which the attorneys general say raise 'serious safety and legal concerns.' The second has to do with patient agreement forms. All patients who want mifepristone — even those using the drug to treat a miscarriage — are required to sign a document stating they are using the drug to end a pregnancy. The third requirement mentioned in the petition is connected to pharmacy certification. As part of mifepristone's REMS program, pharmacies that carry the drug are subject to tracking, shipping and reporting requirements, which the attorneys general argue may 'dissuade' some from carrying the drug. The FDA has yet to reply to a request for comment from The Hill about the petition.
Yahoo
a day ago
- Health
- Yahoo
New York, other states urge FDA to expand access to abortion pill
By Jonathan Stempel NEW YORK (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 outdated restrictions still in place 25 years after its approval. Thursday's petition came after Health and Human Services Secretary Robert F. Kennedy Jr told Congress last month he directed FDA Commissioner Marty Makary to review the pill, saying "alarming" new data suggested at minimum that the label should be changed. Mifepristone, together with the drug misoprostol, won FDA approval in 2000 for medication abortion in the first 10 weeks of pregnancy. 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. New York Attorney General Letitia James said the FDA's Risk Evaluation and Mitigation Strategy program imposes "medically unnecessary" rules that keep mifepristone out of reach of most primary care settings. She called the 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." 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. The White House under Republican President Donald Trump has largely sided with abortion opponents, though 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.
Reuters
a day ago
- Business
- Reuters
New York, other states urge FDA to expand access to abortion pill
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 outdated restrictions still in place 25 years after its approval. Thursday's petition came after Health and Human Services Secretary Robert F. Kennedy Jr told Congress last month he directed FDA Commissioner Marty Makary to review the pill, saying "alarming" new data suggested at minimum that the label should be changed. Mifepristone, together with the drug misoprostol, won FDA approval in 2000 for medication abortion in the first 10 weeks of pregnancy. 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. New York Attorney General Letitia James said the FDA's Risk Evaluation and Mitigation Strategy program imposes "medically unnecessary" rules that keep mifepristone out of reach of most primary care settings. She called the 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." 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. The White House under Republican President Donald Trump has largely sided with abortion opponents, though 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.
Yahoo
20-05-2025
- Health
- Yahoo
Abortion providers challenge FDA's remaining mifepristone restrictions in federal court
'We just want to ensure that the most popular method for abortion in Virginia and beyond is protected no matter who sits at the White House and who sits in the FDA,' said Whole Woman's Health founder and president Amy Hagstrom Miller outside of the U.S. District Court of the Western District of Virginia in Charlottesville, Virginia, on May 19, 2025. (Photo by Charlotte Rene Woods/Virginia Mercury) CHARLOTTESVILLE, Va. — Abortion pills — and questions over their inherent safety — were back in federal court Monday. Unlike a lawsuit rejected by the U.S. Supreme Court last year, plaintiffs this time are not anti-abortion activists arguing medication abortion should be banned, but abortion providers arguing the remaining restrictions should be lifted to match the drug's 25-year record of safety and efficacy. The suit seeks to make abortion pills more accessible by removing several existing restrictions on the U.S. Food and Drug Administration's mifepristone-misoprostol regimen first approved in 2000. The drug was approved under the FDA's drug safety program called Risk Evaluation and Mitigation Strategy (REMS), provisions of which have been steadily eliminated over time but not fully. On behalf of independent providers in Virginia, Montana, and Kansas, Center for Reproductive Rights senior counsel Linda Goldstein argued the FDA's most recent evaluations did not properly assess whether remaining restrictions are still medically necessary. She argued that the biggest risks the FDA has identified with mifepristone — serious bleeding and infection — are not exclusive to the drug but with all pregnancy terminations, including spontaneous miscarriages, which she said affected about 25% of all pregnancies. Beyond abortion, for which the drug has captured attention, mifepristone is also used to treat miscarriages so that they conclude safely to help prevent infection. 'The FDA has acknowledged that staying pregnant is more dangerous than not staying pregnant,' said Goldstein, arguing that at minimum the FDA should be required to explain why drugs that pose similar risks are not subject to the same restrictions. She noted that of the 20,000 drugs the FDA has approved, only 73 have REMS provisions, and that mifepristone has proven to be a safe drug over time. About 7.5 million U.S. patients have taken it as of the end of last year, Goldstein said. As of December 2024, the FDA has reported 36 patient deaths associated with mifepristone since it was first approved in 2000. Whole Woman's Health Alliance v. FDA is the first time the U.S. Department of Justice is arguing a position on mifepristone in court since the Trump administration took office. Justice Department attorneys said current regulations are necessary for the most common form of pregnancy termination to be considered safe. When asked by the judge, DOJ attorney Noah Katzen did not confirm or deny whether or not the FDA still considers the drug to be safe and effective overall. 'That is what the FDA determined in the past,' Katzen said during the hearing at the U.S. District Court for the Western District of Virginia in Charlottesville, where the case was originally filed in 2023. Katzen, the FDA's former associate chief counsel until 2021 and currently a trial attorney for the Consumer Financial Protection Bureau, said the FDA has found that the evidence was 'not sufficient' to conclude the REMS are no longer necessary. U.S. District Judge Robert S. Ballou, appointed by Democratic President Joe Biden, appeared more sympathetic to plaintiffs' argument that some of the requirements appear arbitrary in that they don't apply to other drugs with equal or greater risk, including drugs his parents have taken. Ballou did not rule at the end of Monday's hearing but said he would as soon as possible. After the hearing, Whole Woman's Health Alliance founder and president Amy Hagstrom Miller told States Newsroom she took note of Katzen's response about whether the FDA considers mifepristone to be safe and effective. 'It was an interesting choice of words,' she said. This lawsuit is among several federal cases involving mifepristone. Earlier this month, the Trump administration filed a brief in the case Missouri v. FDA, requesting the court dismiss three states' lawsuit to restrict mifepristone on procedural grounds, but did not comment on the merits of the case or explicitly defend the FDA's current medication abortion policy. While the Missouri v. FDA lawsuit seeks to reinstate regulations loosened between 2016 and 2021, the Whole Woman's Health v. FDA lawsuit takes aim at restrictions that require: medical professionals who prescribe mifepristone to register with the drug manufacturer; pharmacies to apply for special certification and maintain copious records, and patients to review and sign a counseling form. On behalf of plaintiffs, which include Whole Woman's Health Alliance in Virginia and other states, All Families Healthcare and Blue Mountain Clinic in Montana, and Trust Women in Kansas, Goldstein argued that these existing rules are burdensome and make these medications harder to access by limiting the number of providers and pharmacies who can provide and dispense it and impede access to time-sensitive care. Goldstein noted the 'political climate' surrounding mifepristone and pointed to how abortion opponents seek either rescinding of FDA approval for mifepristone or a return to the in-person dispensing requirements. She added how efforts to make abortion medication more difficult to obtain are outlined in Project 2025 — the conservative Heritage Foundation's playbook. Before and especially since Roe v. Wade was overturned in 2022, anti-abortion groups have tried to convince courts that abortion pills, in addition to ending the lives of embryos and fetuses, harm pregnant people at rates that warrant being pulled from the market or at the very least heavily restricted. During his presidential campaign and since taking office, President Donald Trump and his health appointees have messaged strategically on medication abortion, on the one hand promising to retain its access while also open to examining new evidence suggesting it is unsafe. Just last week, U.S. Health and Human Services Secretary Robert F. Kennedy Jr. said he would direct the FDA to review abortion pill safety and potentially change its drug label, following the release of an anti-abortion white paper commissioned by far-right funders, whose analysis has been widely criticized by reproductive health scientists and is outflanked by hundreds of studies showing a very low rate of serious adverse events. Hagstrom Miller called the current restrictions 'politically motivated' and said overturning them would be especially significant for Virginia, which as the least restrictive state in the South, has seen an uptick in people traveling from elsewhere to receive care. 'They're not related to the safety of the medication,' Hagstrom Miller said, of the current restrictions. 'We just want to ensure that the most popular method for abortion in Virginia and beyond is protected no matter who sits at the White House and who sits in the FDA.' Virginia moves to protect reproductive and voting rights, but the fight is far from over Virginia is in the process of amending its state constitution to enshrine abortion and other reproductive health care procedures or medications. The constitutional amendment passed the legislature on party-line votes this year and must pass again next year before appearing on ballots for voters statewide. Its continued success or failure hinges on the outcome of the state's competitive House of Delegates elections — where Democrats hold a slim majority. While governors don't have a say in constitutional amendments, the issue is a divergence between gubernatorial candidates Lt. Gov. Winsome Earle-Sears and Democratic challenger former Congresswoman Abigail Spanberger. This means that should the amendment fail and partisan control of the House shift, whoever is the next governor could advance or block potential future efforts to walk back Virginia's current abortion access laws. 'It's really important that we protect that safe access to medication abortion no matter where people live — Virginia is playing a key role in the South right now,' Hagstrom Miller said. SUPPORT: YOU MAKE OUR WORK POSSIBLE
