Introduction to FDA Approval of Generic Abortion Pill
The FDA has approved another generic version of the abortion pill mifepristone, a move that has sparked criticism from anti-abortion groups and politicians. This regulatory approval is a formality that has quickly triggered pushback from those opposed to abortion.
Background on Mifepristone
Mifepristone is a pill approved to end pregnancies through 10 weeks. It works by dilating the cervix and blocking the hormone progesterone, while another drug, misoprostol, causes the uterus to cramp and contract. The combination of these two drugs accounts for roughly two-thirds of all U.S. abortions.
FDA Approval Process
The FDA approved the original version of mifepristone in 2000 and gradually eased access over time. In 2019, the FDA approved the first generic pill, from drugmaker GenBioPro. The approval of generic drugs is typically a rote process at the FDA, with multiple copycat versions usually approved after the patent on the original drug expires.
Reaction to FDA Approval
Students for Life Action, which opposes abortion, called the approval “a stain on the Trump presidency and another sign that the deep state at the FDA must go.” Republican Sen. Josh Hawley of Missouri also criticized the move, stating: “I have lost confidence in the leadership at FDA.” A spokesperson for the agency said the FDA “has very limited discretion in deciding whether to approve a generic drug,” and added that FDA officials do not “endorse any product.”
Ongoing Controversy
The criticism comes as Republican President Donald Trump’s top health officials, including Health Secretary Robert F. Kennedy Jr., face growing pressure from abortion opponents to reevaluate mifepristone. In a letter to Republican attorneys general last month, Kennedy and FDA Commissioner Dr. Marty Makary pledged to conduct a full review of the drug’s safety.
Access to Mifepristone
Access to mifepristone is restricted across large sections of the country because of state laws that ban abortion — including medication abortion — or impose separate restrictions on the drug’s use. Those laws are subject to a number of ongoing lawsuits that are winding their way through the legal system. Restrictions on the pill are not supported by most major medical societies, including the American Medical Association.
Evita Solutions and Generic Mifepristone
Drugmaker Evita Solutions announced on its website that the Food and Drug Administration signed off on its low-cost form of the pill. The company did not immediately respond to requests for comment. On its website, Evita states that it “believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care.”
Conclusion
The FDA approval of another generic version of mifepristone is a significant development in the ongoing debate over access to abortion. While the approval is unlikely to affect access to the pill, it has sparked criticism from anti-abortion groups and politicians. As the controversy continues, it is essential to consider the impact of restrictions on access to mifepristone and the importance of ensuring that all individuals have access to safe and effective abortion care.
FAQs
- What is mifepristone, and how does it work?
Mifepristone is a pill approved to end pregnancies through 10 weeks. It works by dilating the cervix and blocking the hormone progesterone, while another drug, misoprostol, causes the uterus to cramp and contract. - What is the FDA approval process for generic drugs?
The FDA approval process for generic drugs is typically a rote process, with multiple copycat versions usually approved after the patent on the original drug expires. Generic drugmakers only need to show that their drug matches the ingredients and formula used in the original medication. - What are the restrictions on access to mifepristone?
Access to mifepristone is restricted across large sections of the country because of state laws that ban abortion — including medication abortion — or impose separate restrictions on the drug’s use. - What is the position of major medical societies on restrictions on mifepristone?
Restrictions on the pill are not supported by most major medical societies, including the American Medical Association.By MATTHEW PERRONE, AP Health Writer
WASHINGTON (AP) — Federal officials have approved another generic version of the abortion pill mifepristone, a regulatory formality that quickly triggered pushback from anti-abortion groups and politicians aligned with the Trump administration.
Drugmaker Evita Solutions announced on its website that the Food and Drug Administration signed off on its low-cost form of the pill, which is approved to end pregnancies through 10 weeks.
Students for Life Action, which opposes abortion, in a statement Thursday called the approval “a stain on the Trump presidency and another sign that the deep state at the FDA must go.”
Republican Sen. Josh Hawley of Missouri also criticized the move in a post on X, stating: “I have lost confidence in the leadership at FDA.”
A spokesperson for the agency said the FDA “has very limited discretion in deciding whether to approve a generic drug,” and added that FDA officials do not “endorse any product.”
The criticism comes as Republican President Donald Trump’s top health officials, including Health Secretary Robert F. Kennedy Jr., face growing pressure from abortion opponents to reevaluate mifepristone, which was approved 25 years ago and has repeatedly been deemed safe and effective by FDA scientists.
In a letter to Republican attorneys general last month, Kennedy and FDA Commissioner Dr. Marty Makary pledged to conduct a full review of the drug’s safety.
The FDA approved the original version of mifepristone in 2000 and gradually eased access over time. That included approving the first generic pill, from drugmaker GenBioPro, in 2019.
In 2021, the FDA under Democratic President Joe Biden permitted online prescribing and mail-order delivery of the drug, greatly expanding access. Abortion opponents have been fighting the change ever since.
Approval of generic drugs is typically a rote process at the FDA, with multiple copycat versions usually approved after the patent on the original drug expires. In most cases, generic drugmakers only need to show that their drug matches the ingredients and formula used in the original medication.
“This is exactly how our system is supposed to work, and it has worked this way for decades,” said Mini Timmaraju of Reproductive Freedom for All. “Career scientists and civil servants at the FDA did their jobs.”
The FDA typically approves such applications within 10 months. But filing documents posted to the FDA’s website show that Evita Solutions filed its application to market mifepristone four years ago.
The company did not immediately respond to requests for comment.
On its website, Evita states that it “believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care.”
Approval of a second generic is unlikely to affect access to the pill, which is typically taken with another drug, misoprostol. The combination accounts for roughly two-thirds of all U.S. abortions. Mifepristone dilates the cervix and blocks the hormone progesterone, while misoprostol causes the uterus to cramp and contract.
Access to mifepristone is restricted across large sections of the country because of state laws that ban abortion — including medication abortion — or impose separate restrictions on the drug’s use. Those laws are subject to a number of ongoing lawsuits that are winding their way through the legal system.
Restrictions on the pill are not supported by most major medical societies, including the American Medical Association.
Associated Press writer Christine Fernando in Chicago contributed reporting.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Originally Published: October 2, 2025 at 3:52 PM EDT
