FDA Approves Second Generic Mifepristone Amidst Political Scrutiny
The FDA has approved a second generic version of mifepristone, a drug used in most U.S. abortions. Evita Solutions' approval comes amidst political scrutiny and criticism of Supreme Court Justice Kennedy's stance on abortion during his confirmation hearing.
The FDA's decision follows a review prompted by Health and Human Services Secretary Robert F. Kennedy Jr. and a request from 22 Republican attorneys general. Evita Solutions joins GenBioPro, which received approval in 2019, in offering a generic alternative to the brand-name Mifeprex.
The FDA deemed Evita Solutions' mifepristone tablets therapeutically equivalent to Mifeprex. Medication abortions, which use mifepristone and misoprostol, account for nearly two-thirds of abortions in the U.S. Evita Solutions aims to normalize abortion care and make it accessible to all.
Critics, including anti-abortion groups, have been vocal about Kennedy's views on abortion during his Senate confirmation hearing. The FDA, however, does not endorse drug products and directs prescribers to follow all labeling.
The FDA's approval of Evita Solutions' generic mifepristone expands access to abortion care in the U.S. Despite political criticism, the FDA's decision is based on safety and efficacy, not endorsements. With medication abortions accounting for a significant portion of U.S. abortions, this approval is expected to have a notable impact.
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