U.S. Supreme Court issues stay in Danco Laboratories case over mifepristone

On Friday, U.S. Supreme Court Justice Samuel Alito, Jr. issued an administrative stay that will allow Mifeprex to remain on the market under all approved conditions while the Supreme Court considers Danco’s request for a longer stay pending appeal.

“We are grateful the Court is taking additional time to weigh our client’s request for a stay pending appeal,” said Hogan Lovells partner Jessica Ellsworth. “Danco’s ability to market and distribute Mifeprex was in untenable limbo, creating confusion and causing anxiety for providers, for women, and for healthcare systems all trying to navigate these uncharted waters.”

The case was brought in Texas by parties seeking to block the use of mifepristone. On April 7, Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas issued an order suspending the U.S. Food and Drug Administration’s (FDA) 2000 approval of Mifeprex and subsequent FDA actions regarding the drug.

Danco and the federal government appealed the order to the Fifth Circuit Court of Appeals, which lifted the suspension of the FDA’s 2000 approval, but left in place the suspension of subsequent FDA actions.

“The unprecedented orders from the District Court and Fifth Circuit have created regulatory chaos across the country,” Ellsworth said. “We are hopeful the Supreme Court will grant Danco’s requested stay pending appeal so that these unfounded orders do not restrict the availability of an essential health care product while the issues in this case are considered on appeal.”

The administrative stay issued on Friday runs until midnight on April 19, providing time for the Court to rule on the applications from Danco and the federal government for a broader stay.

The Hogan Lovells team is led by Ellsworth, a partner in the firm’s Appellate practice in the Washington, D.C. office. The team includes Cate Stetson, co-head of the firm’s Appellate practice, as well as partners Philip Katz and Lynn Mehler, both members of the firm’s Pharmaceuticals and Biotechnology practice, which Mehler heads, senior associates Kaitlyn Golden and Danielle Desaulniers Stempel, and associates Marlan Golden, Delia Scoville (all Washington, D.C.), and associate Eva Schifini (Los Angeles).

Danco’s petition for a stay is here.

Danco’s statement is here.