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NBC News
2 days ago
- Health
- NBC News
Four states petition the FDA to lift abortion pill restrictions
Four states petitioned the Food and Drug Administration on Thursday to lift its lingering restrictions on abortion pills. The attorneys general of California, Massachusetts, New Jersey and New York argue in the petition that the FDA's current regulations make it difficult to prescribe mifepristone — one of two pills involved in a medication abortion — in primary care settings, despite evidence that it's safe to do so. '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 in a statement. 'The FDA must follow the science and lift these unnecessary barriers that put patients at risk and push providers out of care.' The drug is a central flash point in the abortion debate. Many anti-abortion groups see restricting who can get mifepristone or rescinding its approval as one of the most effective ways to limit abortion access nationwide. The petition comes just days after FDA Commissioner Marty Makary said he was committed to conducting a safety review of mifepristone. Health and Human Services Secretary Robert F. Kennedy Jr. and Sen. Josh Hawley, R-Mo., each requested the review following the release of a paper, which was neither peer-reviewed nor published in a medical journal, that claimed to find a high rate of serious adverse events in women who recently took the medication. Researchers who study reproductive health said the report amounts to junk science and exaggerates the risks of mifepristone. They note that it does not meet basic research standards, relying on overly broad definitions and failing to disclose which database it used. The report was released by the Ethics and Public Policy Center, a conservative think tank that served on the advisory board of Project 2025, a right-wing policy initiative that called for the FDA to walk back its approval of mifepristone. The attorneys general said Thursday that the FDA should use the safety review as an opportunity to remove barriers to accessing mifepristone nationwide — or, at minimum, in the four states involved in the petition. The FDA regulates certain medications with serious safety concerns via a drug safety program called Risk Evaluation and Mitigation Strategies (REMS). Mifepristone is currently part of that program, though a wealth of research has shown that less than 0.5% of women who take it have serious adverse reactions. Studies have also demonstrated that prescribing mifepristone through telehealth is as safe and effective as administering it in person. As part of the REMS program, mifepristone is subject to a few restrictions: People who prescribe the pills must be certified health care providers, and pharmacies must obtain certifications to dispense the medication. Patients who receive mifepristone must also sign a form attesting that they intend to end their pregnancy. The attorneys general said in their petition that those restrictions are burdensome and unnecessary. They claim that many primary care and family medicine physicians aren't able or willing to take on the administrative burden of getting certified to prescribe the pills, or are worried about being added to a list of national or local abortion providers. The FDA has already lifted several restrictions on mifepristone over the last decade. In 2016, it extended the window in which mifepristone could be used to terminate pregnancies from seven weeks' gestation to 10 weeks. In 2019, it approved a generic form of the medication, which increased supply. And in 2021, it eliminated a requirement to dispense mifepristone in person, allowing the drug to be prescribed via telehealth and sent by mail. Anti-abortion groups have called on the FDA to reinstate those restrictions, often pointing to misleading studies that suggest the medication has harmful effects. The April report that launched the FDA safety review, for instance, claims to find a 22-times higher rate of serious complications from mifepristone than reported by the agency. In their petition Thursday, the four attorneys general denounced recent attempts to challenge mifepristone's safety, which they said rely on methodologically flawed research. A coalition of anti-abortion groups sued the FDA in 2022 over its approval of mifepristone, citing two studies from the Charlotte Lozier Institute, a group that opposes abortion, that claimed to show severe complications from the drug. The lawsuit was ultimately thrown out by the Supreme Court and the studies were later retracted by a medical publisher. The Charlotte Lozier Institute released another paper last month claiming that a growing number of emergency room visits after abortions are incorrectly attributed to miscarriages, thereby masking abortion complications. Rachel Jones, a principal research scientist at the Guttmacher Institute, a research organization that supports abortion access, said the data only captures a small portion of abortions and is skewed in favor of those that are potentially higher risk. Some of the same data was used in the retracted studies, she said. Jones added that the timing of the new reports from anti-abortion groups is not coincidental. 'The anti-choice people are really going after medication abortion and doing whatever they can to get the FDA under the Trump administration to revisit the availability of the drug,' she said.
The Hill
28-02-2025
- Health
- The Hill
Abortion medication faces RFK Jr. scrutiny
The prior comments from Kennedy are raising fears that the HHS chief is open to restrictions on the pill. 'President Trump has asked me to study the safety of mifepristone,' Kennedy said during a confirmation hearing. 'He has not yet taken a stand on how to regulate it. Whatever he does, I will implement those policies.' Health policy experts do not think that Kennedy will try to remove the drug from the market straight away. Instead, they think he might direct agencies within HHS to change who can take mifepristone and how it can be administered. Right now, mifepristone can be prescribed online and sent through the mail and is approved to end a pregnancy in the first 10 weeks of gestation. Health experts who spoke to The Hill agreed the easiest way Kennedy could change access to the drug is through trying to alter its Risk Evaluation and Mitigation Strategies (REMS). REMS are regulations added to some medications with safety concerns. REMS changes typically take time, but there's concern that the Trump administration could try to speed up the process by issuing an executive order based on a study claiming mifepristone is dangerous for public consumption and applying pressure to the FDA to restore previous restrictions. What's a REMS: The Food and Drug Administration (FDA) is responsible for protecting public health by ensuring medications are safe and effective. One of the ways the agency does this is by implementing REMS. REMS can include some interventions to ensure the safe use of a drug, like requiring patients to undergo certain tests before they can be prescribed a medication or requiring that it be administered in clinic. Mifepristone has had a REMS since it was first approved by the FDA in 2000, and it's been modified multiple times over the years, most recently in 2023 when the FDA dropped an in-person dispensing requirement for the drug. Changing the REMS for a drug is not normally a quick process. Often, it is the drug manufacturer that requests changes to these rules, although the FDA can also request changes. Typically, the agency needs to work with the manufacturer to roll out those modifications.
Yahoo
27-02-2025
- Health
- Yahoo
How RFK Jr. could restrict abortion medication access
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has suggested that he is open to restricting access to abortion medication, the primary method used for abortions across the U.S. Kennedy pledged to study the abortion drug mifepristone on President Trump's request during his confirmation hearings, citing 'safety issues.' He did not offer further explanation of what those issues were. 'President Trump has asked me to study the safety of mifepristone,' Kennedy said during the hearings last month. 'He has not yet taken a stand on how to regulate it. Whatever he does, I will implement those policies.' If the administration does seek to restrict access to the drug, health policy experts do not think Kennedy will attempt to remove it from the market, but say he could instead try to direct agencies within HHS to limit who can take mifepristone and how it can be administered. 'If you are trying to make a product harder to access … you are going to institute restrictions that reduce the ease in which people can access the product,' said Caleb Alexander, a physician and professor at the Johns Hopkins Bloomberg School of Public Health with research focus on drug utilization and safety. HHS oversees 13 agencies including the Food and Drug Administration (FDA), which is responsible for protecting public health in part by making sure that the country's drug supplies are safe and effective for consumption. One way the FDA tries to ensure that medications are safe is by implementing Risk Evaluation and Mitigation Strategies (REMS). These are a series of rules the agency imposes on some drugs to prevent, monitor and manage the frequency or severity of adverse health events, according to the FDA's website. They can include some interventions to ensure the safe use of medication, like an in-person dispensing requirement. Mifepristone was previously under such a requirement until the Biden administration dropped it. Altering the REMS associated with the drug would be the most direct way to change who can take it and how, health experts said. Though changes to REMS are often requested by the drug manufacturer, the FDA can also determine if a change is needed, according to agency guidelines. It still typically needs to work with the drug producer in those cases, however. 'The FDA may release a REMS or remove certain components of a REMS, if, after review of REMS assessments or other information, we determine that the extra measures in a REMS are no longer necessary to ensure a medication's benefits outweigh its risks,' the agency's website reads. To change REMS for a drug, the FDA would need to provide evidence that itposes a danger to people and that the current REMS do not protect consumers well enough from those risks, health experts said. The FDA first approved the abortion medication Mifeprex in 2000 and more than 100 studies conducted in at least 26 countries have found that most patients who have taken the drug have not experienced a serious complication like hospitalization or surgery. Typically, the process for changing REMS doesn't happen 'overnight,' according to Laurie Sobel, associate director of women's health policy at health research nonprofit KFF. But she suggestedthe process could be different under Trump, saying the administration could potentiallyissue an emergency declaration based on a study arguing that mifepristone is dangerous and revert back to earlier REMS for the drug. Such a move could eventually make it harder to access to drug by reinstituting rules thatallowed only certain clinicians the right to prescribe it, she said. Since 2000, the abortion medication has had a series of REMS that have been modified. The Biden-era FDA's announcement in 2021 that it woulddrop its requirement that the drug be dispensed in person to patients marked one of the more recent modifications. That requirement was officially dropped in 2023, with the agency releasing new REMS for the drug. In addition to seeking to roll back that change, the Trump FDA could also possibly suggest placing new requirements in the REMS that patients seeking mifepristone must undergo specific tests before they can be given the drug or be observed for a certain amount of time in clinic after it, according to Alexander. If the agency were to suggest changes to REMS for mifepristone, the drug's manufacturers Danko Laboratories and GenBioPro, which creates a generic version of the drug, would likely challenge the changes in court, health experts said. 'But it's unclear how successful that challenge might be,' said Sobel. The FDA did not answer questions from The Hill about REMS for mifepristone. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
The Hill
27-02-2025
- Health
- The Hill
How RFK Jr. could restrict abortion medication access
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has suggested that he is open to restricting access to abortion medication, the primary method used for abortions across the U.S. Kennedy pledged to study the abortion drug mifepristone on President Trump's request during his confirmation hearings, citing 'safety issues.' He did not offer further explanation of what those issues were. 'President Trump has asked me to study the safety of mifepristone,' Kennedy said during the hearings last month. 'He has not yet taken a stand on how to regulate it. Whatever he does, I will implement those policies.' If the administration does seek to restrict access to the drug, health policy experts do not think Kennedy will attempt to remove it from the market, but say he could instead try to direct agencies within HHS to limit who can take mifepristone and how it can be administered. 'If you are trying to make a product harder to access … you are going to institute restrictions that reduce the ease in which people can access the product,' said Caleb Alexander, a physician and professor at the Johns Hopkins Bloomberg School of Public Health with research focus on drug utilization and safety. HHS oversees 13 agencies including the Food and Drug Administration (FDA), which is responsible for protecting public health in part by making sure that the country's drug supplies are safe and effective for consumption. One way the FDA tries to ensure that medications are safe is by implementing Risk Evaluation and Mitigation Strategies (REMS). These are a series of rules the agency imposes on some drugs to prevent, monitor and manage the frequency or severity of adverse health events, according to the FDA's website. They can include some interventions to ensure the safe use of medication, like an in-person dispensing requirement. Mifepristone was previously under such a requirement until the Biden administration dropped it. Altering the REMS associated with the drug would be the most direct way to change who can take it and how, health experts said. Though changes to REMS are often requested by the drug manufacturer, the FDA can also determine if a change is needed, according to agency guidelines. It still typically needs to work with the drug producer in those cases, however. 'The FDA may release a REMS or remove certain components of a REMS, if, after review of REMS assessments or other information, we determine that the extra measures in a REMS are no longer necessary to ensure a medication's benefits outweigh its risks,' the agency's website reads. To change REMS for a drug, the FDA would need to provide evidence that itposes a danger to people and that the current REMS do not protect consumers well enough from those risks, health experts said. The FDA first approved the abortion medication Mifeprex in 2000 and more than 100 studies conducted in at least 26 countries have found that most patients who have taken the drug have not experienced a serious complication like hospitalization or surgery. Typically, the process for changing REMS doesn't happen 'overnight,' according to Laurie Sobel, associate director of women's health policy at health research nonprofit KFF. But she suggestedthe process could be different under Trump, saying the administration could potentiallyissue an emergency declaration based on a study arguing that mifepristone is dangerous and revert back to earlier REMS for the drug. Such a move could eventually make it harder to access to drug by reinstituting rules thatallowed only certain clinicians the right to prescribe it, she said. Since 2000, the abortion medication has had a series of REMS that have been modified. The Biden-era FDA's announcement in 2021 that it woulddrop its requirement that the drug be dispensed in person to patients marked one of the more recent modifications. That requirement was officially dropped in 2023, with the agency releasing new REMS for the drug. In addition to seeking to roll back that change, the Trump FDA could also possibly suggest placing new requirements in the REMS that patients seeking mifepristone must undergo specific tests before they can be given the drug or be observed for a certain amount of time in clinic after it, according to Alexander. If the agency were to suggest changes to REMS for mifepristone, the drug's manufacturers Danko Laboratories and GenBioPro, which creates a generic version of the drug, would likely challenge the changes in court, health experts said. 'But it's unclear how successful that challenge might be,' said Sobel.
