FDA Approves Generic Abortion Pill Mifepristone for January Launch
The FDA has approved another generic version of the abortion pill mifepristone, set to launch in January. This comes amidst ongoing restrictions and debates surrounding the drug's access across the country.
Mifepristone, first approved in 2000, has seen its access gradually ease over time. However, state laws banning abortion or imposing separate restrictions on the drug's use still limit access in large sections of the country.
The FDA's approval of a generic version by Evita Solutions is expected to increase affordability and availability. However, it has drawn criticism from groups like Students for Life Action and Sen. Josh Hawley, who raised concerns about the FDA's leadership and decisions. The FDA maintains limited discretion in approving generic drugs, as per a spokesperson.
Pressure from abortion opponents, including Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary, has previously led to delays in FDA decisions, including on vaccines. The approval process for generic drugs is typically straightforward, with multiple copycat versions usually approved after the original drug's patent expires.
Evita Solutions' low-cost generic mifepristone is set to hit the market in January, potentially expanding access to the abortion pill. Despite criticism and ongoing debates, the FDA's approval process for generic drugs remains largely procedural.
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