Mifepristone Marks 25 Years of FDA Approval, Now Faces Uncertain Future Amid Intensifying Anti-Abortion Pressure

Mifepristone Marks 25 Years of FDA Approval, Faces Uncertain Future On September 28, 2000, the US Food and Drug Administration (FDA) approved mifepristone for use in medical abortions. Twenty-five years later, the drug's future is under threat as anti-abortion Republicans push to revoke its approval. Mifepristone, a medication that blocks the pregnancy hormone progesterone, was first used in France in 1989 and has since become a crucial component of the standard abortion pill regimen. When combined with misoprostol, it causes the uterus to contract, expelling the pregnancy. The FDA's approval of mifepristone allowed pregnant individuals to have abortions in the comfort of their own homes, reducing the need for clinic visits and minimizing encounters with anti-abortion protesters. "Mifepristone has revolutionized abortion access in the US," said Dr. Daniel Grossman, a reproductive health expert at the University of California, San Francisco. "It's allowed people to have control over their bodies and make decisions about their own healthcare." Initially approved for use up to seven weeks of pregnancy, mifepristone has been shown to be safe and effective in terminating pregnancies through 10 weeks. However, its approval is now under attack by anti-abortion lawmakers who aim to restrict access to abortion nationwide. The House of Representatives passed a bill in July that would revoke the FDA's approval of mifepristone, citing concerns over its safety and efficacy. The legislation has been sent to the Senate for consideration, where it faces an uncertain future. "Mifepristone is a safe and effective medication that has been extensively studied," said Dr. Julie R. Oakley, a reproductive endocrinologist at the University of California, Los Angeles. "Revoking its approval would be a step backward for women's health and reproductive rights." The FDA's approval process for mifepristone was rigorous and involved multiple studies demonstrating its safety and efficacy. The agency has continued to monitor the medication's use and has made adjustments to its labeling over the years. As the debate over mifepristone's future continues, reproductive health advocates are sounding the alarm about the implications of revoking its approval. "If mifepristone is taken off the market, it will have a devastating impact on women's access to abortion," said Dr. Grossman. "It will force people to seek out clandestine and potentially unsafe procedures." The outcome of this battle remains uncertain, but one thing is clear: the future of mifepristone hangs in the balance. Background Mifepristone was first approved in France in 1989 under the brand name RU-486. It was developed by French scientists Roger Baulieu and Etienne-Emile Baulieu. The FDA's approval of mifepristone in 2000 marked a significant shift in abortion access, allowing pregnant individuals to have abortions at home. Additional Perspectives Reproductive rights advocates argue that revoking mifepristone's approval would be a step backward for women's health and reproductive rights. "Mifepristone is a safe and effective medication that has been extensively studied," said Dr. Oakley. "Revoking its approval would be a disservice to the millions of people who rely on it for abortion access." Anti-abortion lawmakers argue that mifepristone poses safety risks and should be removed from the market. However, reproductive health experts counter that the medication has been extensively studied and is safe when used as directed. Current Status The House of Representatives passed a bill in July to revoke the FDA's approval of mifepristone. The legislation has been sent to the Senate for consideration, where it faces an uncertain future. Reproductive health advocates are urging lawmakers to protect access to abortion and preserve the FDA's approval of mifepristone. Next Developments The outcome of this battle remains uncertain, but one thing is clear: the future of mifepristone hangs in the balance. As the debate continues, reproductive health advocates will continue to push for protection of access to abortion and preservation of the FDA's approval of mifepristone. *Reporting by Motherjones.*