"The HHS's decision is not an endorsement of this drug by any means. They are simply following the law. She continued: And as they put out in their statement, By law, the secretary of Health and Human Services must approve a generic drug application if the application demonstrates the generic drug is the quote, same,' as the brand-name drug. Generic applicants are not required to submit independent evidence proving safety and effectiveness."
"As such, the FDA's decision to approve a second generic version does not address the merits of the current safety program. HHS is reviewing adverse effects to ensure the FDA's required safety program for the drug is sufficient to protect women. The safety review equally applies to generic versions of this drug. She summed up, So, FDA and HHS are following the law. Again, it's not an endorsement of the drug itself."
The FDA approved a generic version of the abortion drug mifepristone. Republican lawmakers, including Sen. Josh Hawley, expressed strong opposition and safety concerns. HHS described its decision as not endorsing the drug and indicated the department is following legal requirements for generic approval. By law, a generic must demonstrate that it is the same as the brand-name drug, and generic applicants are not required to submit independent safety and effectiveness evidence. HHS is reviewing adverse effects to determine whether the FDA's required safety program sufficiently protects women, and that review applies equally to generic versions.
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