Here’s what you need to know and BIO’s take.
The news: The Supreme Court ruled on Friday that mifepristone will remain accessible during the appeals process of the April 7 Texas ruling that would have declared the Food and Drug Administration (FDA) approval of the drug invalid.
Important: This is not final; the Supreme Court returned the case to the U.S. 5th Circuit Court of Appeals.
BIO’s take: “Today’s decision is an important development for patients and for ensuring access to approved medicines,” says BIO CEO Rachel King. “However, we must redouble our efforts to preserve and protect the FDA’s long-standing role as the authority in determining the safety and efficacy of medicines. As legal and medical experts have noted, the courts do not have the expertise or medical training to make these types of complex scientific determinations. At BIO, we will continue to organize and mobilize on behalf of patients and will work tirelessly to ensure that regulatory decision-making is grounded in scientific and medical expertise.”
What’s next: The 5th Circuit Court of Appeals will hear the case, with oral arguments scheduled for Wednesday, May 17. We’ll be watching closely and will bring you more analysis over the coming days and weeks.
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