Supreme Court says mifepristone can stay – for now

Mifepristone box from Danco Laboratories

After weeks of tension, the Supreme Court decided mifepristone can stay… for now.

On the evening of April 21, the Supreme Court ruled the drug would remain available during the appeals process, sending the headline-dominating Texas case back to the U.S. Court of Appeals for the Fifth Circuit.

Here’s what happened and the biotech industry’s response.

The latest news on mifepristone

The mifepristone abortion pill was approved by the U.S. Food and Drug Administration (FDA) in 2000. Study after study has shown it is safe and effective.

However, U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, placed the hold on the drug on April 7 in an attempt to undermine its FDA’s approval. In response, U.S. District Judge Thomas O. Rice in Washington State issued a competing injunction blocking the FDA from changing the status quo.

The past two weeks have been tense as outcomes were up in the air.

Following an emergency review, the Supreme Court deferred the case to the 5th U.S. Circuit Court of Appeals, set to hear oral arguments on May 17.

What’s next for mifepristone in the courts?

Regardless of the outcome of the appeals process, it is highly likely the case will ultimately return to the SupremeCourt, with a potential ruling in the upcoming term.

President Biden has issued several statements on the case, including his support of the FDA and their rulings on the drug.

“I continue to stand by FDA’s evidence-based approval of mifepristone, and my Administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs,” he said.

Following the Supreme Court’s ruling, Biotechnology Innovation Organization (BIO) CEO Rachel King stated, “Today’s decision is an important development for patients and for ensuring access to approved medicines. 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.”

King also expresses her concern over medical competence within the courts.

“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,” she said.

Why the mifepristone case matters to future drugs

BIO has stated over the past weeks that the ban on mifepristone will threaten the FDA’s credibility.

John Murphy, Chief Policy Officer of BIO, stated that the courts have the right to judicial review over the FDA; however, the courts lack the medical and scientific expertise to make such claims as in this case.

“We don’t think FDA decisions are above judicial review,” he said. “In fact, judicial review is a good check on agency power. But what is concerning are aspects of the judge’s ruling that question the scientific and risk determinations made by FDA. And that is an area that I think for the biotech industry is very problematic.”

On April 12, BIO joined an amicus brief calling for the suspension of the Texas ruling. Read more about this on Bio.News.

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