FDA Approves New Generic Version of Mifepristone Abortion Pill

WASHINGTON — The Food and Drug Administration has approved another generic version of mifepristone, a medication commonly used for medication-induced abortions. This approval has sparked immediate backlash from anti-abortion groups and some Republican lawmakers.

Evita Solutions, the drug manufacturer, announced on its website that the FDA has authorized its low-cost version of mifepristone, which is approved for use in terminating pregnancies up to 10 weeks. The approval comes as Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary face increasing pressure from abortion opponents to reassess the drug's safety.

In a statement, Students for Life Action criticized the approval, calling it “a stain on the Trump presidency and another sign that the deep state at the FDA must go.” Senator Josh Hawley (R-MO) also expressed his discontent, stating, “I have lost confidence in the leadership at FDA.”

The FDA's approval process for generic drugs is typically straightforward. Generic manufacturers must demonstrate that their product is equivalent to the original drug. The FDA usually processes these applications within 10 months. However, Evita Solutions submitted its application four years ago.

The original version of mifepristone was approved in 2000, and the FDA has gradually expanded access to the drug over the years. In 2019, the agency approved the first generic version from GenBioPro. Under the Biden administration in 2021, the FDA allowed online prescribing and mail-order delivery of mifepristone, significantly increasing its availability.

Despite the approval of the new generic, access to mifepristone remains limited in many areas due to state laws that restrict abortion, including medication abortions. These laws are currently being challenged in various lawsuits.

Mifepristone is typically used in combination with another drug, misoprostol, which together account for about two-thirds of all abortions in the U.S. Mifepristone works by blocking the hormone progesterone and dilating the cervix, while misoprostol induces uterine contractions.

Most major medical organizations, including the American Medical Association, do not support restrictions on mifepristone. The FDA has consistently deemed the drug safe and effective, despite ongoing debates surrounding its use.