The Food and Drug Administration has approved a new generic version of mifepristone, which was first cleared for use ending pregnancies through 10 weeks in 2000. The FDA notified Evita Solutions on Tuesday, sparking an outcry from abortion rights opponents though the agency noted that it "has very limited discretion in deciding whether to approve a generic drug," the Washington Post reports. Days ago, Health and Human Services Secretary Robert F. Kennedy Jr. had announced was ordering a fresh review of mifepristone safety at the request of 22 Republican state attorneys general, satisfying abortion opponents. Now they're calling for Kennedy to be fired.
Evita submitted its request to the FDA in October 2021; such applications usually clear within 10 months, per the AP. The company's website says Evita "believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care." Women have increasingly used Mifepristone to terminate pregnancies since the Supreme Court struck down Roe v. Wade in 2022, and now accounts for more than 60% of abortions nationwide. It's typically used along with misoprostol, per the Hill. Approval of a second generic is unlikely to change access to the pill, per the AP. Multiple copycat versions usually win approval after the patent on the original drug expires. Generic drugmakers only need to show that their drug matches the ingredients and formula of the original.
Former Vice President Mike Pence called the FDA's decision "a complete betrayal of the pro-life movement that elected President Trump" and said he wants Kennedy fired. GOP Sen. Josh Hawley posted that he has "lost confidence in the leadership at FDA." Medical experts and advocates have filed documents for Kennedy's review saying that scores of studies have found mifepristone to be safe and serious complications rare, per the New York Times.
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