The FDA has recently approved a new generic version of the abortion pill mifepristone, manufactured by Evita Solutions. This approval has sparked criticism from anti-abortion groups and politicians aligned with the Trump administration, who view it as a controversial decision.
Students for Life Action condemned the approval, calling it “a stain on the Trump presidency” and demanding changes at the FDA. Republican Senator Josh Hawley also expressed his disapproval, stating that he has lost confidence in the FDA’s leadership. However, an FDA spokesperson clarified that the agency has limited discretion in approving generic drugs and does not endorse any specific product.
The approval of this generic version comes amidst pressure from abortion opponents for a reevaluation of mifepristone’s safety. FDA Commissioner Dr. Marty Makary and Health Secretary Robert F. Kennedy Jr. have pledged to conduct a full review of the drug. Despite being approved 25 years ago and deemed safe and effective by FDA scientists, mifepristone continues to face scrutiny.
The original version of mifepristone was approved in 2000, with access to the drug gradually increasing over time. In 2019, the FDA approved the first generic version from GenBioPro. Under President Joe Biden, the FDA permitted online prescribing and mail-order delivery of the drug in 2021, expanding access to it. However, these changes have been met with resistance from abortion opponents.
Generic drug approvals are typically routine processes at the FDA, with companies only needing to demonstrate that their drug matches the original formula. Evita Solutions filed its application for mifepristone four years ago, and the approval process has taken longer than usual. The company’s mission is to provide safe, affordable, and high-quality abortion care to all individuals.
The approval of a second generic version is unlikely to impact access to the pill, which is commonly used in combination with misoprostol for abortion. However, access to mifepristone is restricted in many states due to laws that ban or impose restrictions on abortion. These laws are currently facing legal challenges in the court system.
Despite ongoing controversies and legal battles, most major medical societies, including the American Medical Association, do not support restrictions on mifepristone. The debate surrounding the abortion pill continues to be a hot topic in the realm of reproductive rights and healthcare.
