Federal agencies studying safety of abortion drug mifepristone ‘Properly Protect’ Women
The U.S. Food and Drug Administration Federal (FDA) is currently evaluating data on the safety and effectiveness of a key medication used in abortion care.
The goal of the review is to determine safe dispensing practices, according to a new letter sent by U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and Federal FDA Commissioner Dr. Marty Makary to 22 Republican attorneys general.
“According to Kennedy and Makary, the Federal FDA will conduct an independent review of available data – including real-world results and clinical evidence – to assess the safety and effectiveness of mifepristone
Health and Human Services Secretary
In the September 19 letter, they emphasized that the Administration is committed to safeguarding women’s health by carefully examining the conditions under which mifepristone can be dispensed safely.
Abortion rights advocates worry that the letter signals potential federal restrictions on medication abortion, which in recent years has become more widely accessible through telehealth services.
Food and Drug Administration (FDA)
Earlier this month, Kennedy informed senators that the Federal FDA is gathering new data as part of its safety review of mifepristone, noting that these studies are ongoing. During the hearing, he alleged that the Biden administration had misrepresented data on mifepristone to downplay a potential safety concern, though he did not specify what the issue might be.
Kennedy told the U.S. Senate Committee on Finance that the Federal FDA is continuously receiving and reviewing new data.
Meanwhile, Republican attorneys general pointed to a report from the Ethics and Public Policy Center – a group that identifies itself as working to counter progressive policies and promote conservative consensus – as evidence that mifepristone poses risks and should face stricter oversight.
In their latest response, Kennedy and Makary stated that the report highlights ” potential risks of providing mifepristone without adequate medical guidance or supervision. ” However, many experts dismiss the report as ” junk science, ” noting that it has neither been peer-reviewed nor published in a reputable medical journal.
Society of Family Planning
Dr. Ushma Upadhyay, an associate professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at the University of California, San Francisco, emphasized that a major issue with the report is its lack of transparency. In her 10-point analysis outlining key flaws, she noted that the report provides minimal details about the data sources.
She explained that the report exaggerates the risks linked to mifepristone, noting that it classified any emergency room visit as a serious adverse event-even in cases where no treatment was needed. Other studies indicate that nearly half of abortion-related ER visits are for observation only.
Family Planning
The Society of Family Planning, a nonprofit dedicated to advancing research on abortion and contraception, has called on the Federal FDA to reject the report due to its failure to meet scientific standards. In a letter to Makary, the organization stated, ”
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This paper lacks methodological rigor, is not evidence-based, and should not be considered credible, especially in scientific discussions.
U.S. Approval
In the United States, mifepristone is widely used in combination with misoprostol to perform medication abortions. First approved by the Federal FDA in 2000, the drug has consistently been proven safe and effective and is authorized for use in ending pregnancies up to 10 weeks of gestation.
Extensive clinical research and decades of real-world use have confirmed mifepristone’s safety and effectiveness. According to Federal FDA data, since its U.S. approval in 2000, there have been only 5 deaths per 1 million users-a mortality rate of just 0.0005%.
Studies also show that the drug’s safety profile is comparable to widely used over-the-counter pain relievers such as ibuprofen and acetaminophen.
American College
Leading medical organizations, such as the American College of Obstetricians and Gynecologists, have consistently advocated for broader access to mifepristone. During the COVID -19 pandemic, the Biden administration eased restrictions by permitting certified providers to prescribe the medication through telehealth and deliver it by mail, greatly improving availability, especially in rural regions with limited abortion clinics.
Leading medical organizations, such as the American College of Obstetricians and Gynecologists, have consistently advocated for broader access to mifepristone.
During the COVID -19 pandemic, the Biden administration eased restrictions by permitting certified providers to prescribe the medication through telehealth and deliver it by mail, greatly improving availability, especially in rural regions with limited abortion clinics.
United States Recorded
According to the Guttmacher Institute-a research and policy organization specializing in sexual and reproductive health and supportive of abortion rights-the United States recorded over 1 million abortions in 2024, marking the second consecutive year the number surpassed 1 million.
Since the US Supreme Court’s Dobbs ruling in June 2022 overturned the federal right to abortion, 20 states have either banned or heavily restricted access, while others have enacted new protections for abortion care.
According to the Guttmacher Institute, the wider availability of telehealth clinics offering medication abortion has played a key role in the overall increase. In 2024, about 14% of abortions were provided by online-only clinics, compared with 10% in 2023 – a jump of roughly 40,000 procedures.
