In brief
The U.S. Food and Drug Administration has approved a second generic version of mifepristone, a medication used to terminate pregnancies up to 10 weeks. The approval by Evita Solutions has prompted criticism from anti-abortion advocates, who perceive it as a failure of the Trump administration's efforts to restrict access to abortion medications. Despite ongoing controversies and state-level restrictions limiting access to the drug, supporters argue that broader availability is essential for reproductive rights. The FDA's regulatory processes for generic drugs remain consistent, with approvals often routine upon patent expiration.
WASHINGTON (AP) — Federal officials have affirmed the approval of another generic version of the abortion pill mifepristone, leading to immediate backlash from anti-abortion organizations closely linked with the former Trump administration.
Evita Solutions announced on its website that the Food and Drug Administration (FDA) granted its low-cost formulation of the pill, which is approved for pregnancies up to 10 weeks.
Critics, such as Students for Life Action, condemned the approval as a blemish on the Trump administration, calling for the FDA to face accountability.
This criticism unfolds as Trump’s former health officials, including Health Secretary Robert F. Kennedy Jr., are under pressure from anti-abortion advocates to reassess mifepristone, a drug that has been recognized as safe and effective since its approval 25 years ago.
In a recent letter to Republican attorneys general, Kennedy and FDA Commissioner Dr. Marty Makary promised a comprehensive review of the drug’s safety.
The FDA initially approved mifepristone in 2000, progressively easing access, which included the endorsement of the first generic pill from GenBioPro in 2019.
Under the current administration, the FDA expanded access to mifepristone by permitting online prescriptions and mail-order deliveries, actions that abortion opponents have vehemently contested.
The approval process for generic drugs typically follows a standardized protocol at the FDA, with multiple versions usually sanctioned once the original patent expires. Generally, generic manufacturers simply need to demonstrate that their product matches the original in ingredients and formulation.
The FDA typically completes such applications in under 10 months; however, Evita Solutions filed its request four years ago. The firm has yet to issue a public comment regarding the recent approval.
On its website, Evita Solutions advocates for universal access to safe and high-quality abortion care. The approval of an additional generic variant is not expected to significantly alter access to mifepristone, a drug that is often used along with misoprostol, collectively accounting for about two-thirds of abortions carried out in the U.S.
Despite the approval, access to mifepristone remains restricted in numerous regions due to state laws imposing bans or tight regulations on abortion drugs, with many of these laws entangled in litigation.
Major medical organizations, including the American Medical Association, do not support these restrictions on the pill.
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