WASHINGTON — Federal regulators have given the green light to yet another generic version of the abortion medication mifepristone. This routine regulatory approval has sparked immediate backlash from anti-abortion advocates and politicians associated with the Trump administration.
Evita Solutions, the pharmaceutical company behind the new generic, announced on its website that the Food and Drug Administration has approved its budget-friendly version of the medication, which is sanctioned for use in terminating pregnancies up to 10 weeks.
In response, Students for Life Action released a statement on Thursday labeling the FDA’s approval as “a stain on the Trump presidency and another indication that the deep state at the FDA must be addressed.”
Republican Senator Josh Hawley from Missouri also denounced the decision via a post on X, expressing, “I have lost faith in the FDA’s leadership.”
This criticism arises amidst ongoing pressure on top health officials from the Trump administration, including Health Secretary Robert F. Kennedy Jr., from abortion opponents urging a reassessment of mifepristone, which has been on the market for 25 years and has consistently been assessed as safe and effective by FDA experts.
In a communication sent to Republican state attorneys general last month, Kennedy and FDA Commissioner Dr. Marty Makary committed to an extensive review of the drug’s safety.
The FDA originally approved mifepristone in 2000 and has progressively facilitated broader access. This includes sanctioning the first generic version by GenBioPro in 2019.
In 2021, the FDA, under Democratic President Joe Biden, allowed online prescriptions and mail-order deliveries for this medication, significantly increasing its availability. Abortion opponents have been contesting this change ever since.
Typically, the FDA’s approval of generic drugs is a standard practice, with multiple alternatives usually receiving approval post-expiration of the original drug’s patent. Generally, generic manufacturers are only required to demonstrate that their product mirrors the composition and formulation established by the original creator.
The FDA usually processes such applications within ten months. However, documents on the FDA’s website reveal that Evita Solutions submitted its application to market mifepristone four years ago.
The company did not promptly respond to queries for comment.
Evita emphasizes on its website that it “believes everyone deserves access to safe, affordable, high-quality, effective, and empathetic abortion care.”
The introduction of a second generic version is not expected to alter availability of the medication, which is usually used in conjunction with another drug, misoprostol. Together, these two medications account for around two-thirds of all abortions in the U.S. Mifepristone works by dilating the cervix and blocking the hormone progesterone, while misoprostol induces uterine contractions.
Access to mifepristone remains restricted in numerous regions due to state laws banning abortion, including medical abortion, or placing alternate restrictions on the drug’s application. These laws are currently subject to several ongoing legal challenges progressing through the courts.
Most major medical organizations, including the American Medical Association, do not support restrictions on the medication.
— Matthew Perrone
