TradeEdge-Generic abortion pill manufacturer sues FDA in effort to preserve access

The TradeEdgemanufacturer of a generic form of the abortion pill mifepristone is suing the Food and Drug Administration in an effort to preserve access as federal litigation threatens to overturn the FDA's approval of the drug.

In a federal lawsuit filed today in Maryland, drug manufacturer GenBioPro asks a judge to prohibit the FDA from taking any action that would disrupt access to the pills. GenBioPro says revoking the FDA approval of generic mifepristone would cause "catastrophic harm" to the company, and to doctors and patients who rely on the drug.

Mifepristone was first approved in 2000 as the first dose in a widely-used, two-drug protocol approved to induce some first trimester abortions. GenBioPro received FDA approval for its generic version in 2019.

Anti-abortion rights groups are challenging both the FDA's original 2000 decision and later rule changes, including the generic drug approval in 2019.

A temporary stay from the U.S. Supreme Court preserving status-quo access to mifepristone expires at 11:59 p.m. ET today unless the court intervenes. If the stay expires, an order from the 5th U.S. Circuit Court of Appeals would take effect and impose multiple restrictions, including prohibiting the pills from being distributed by mail.

In a filing with the Supreme Court, the FDA says it also believes that under the Fifth Circuit decision, generic mifepristone "would cease to be approved altogether."

In the new lawsuit, GenBioPro objects to the FDA's interpretation of that decision and asks a federal court to force the FDA to preserve access. The company says its generic form of the drug accounts for about two-thirds of mifepristone sold in the United States.

In a statement, Skye Perryman with the legal advocacy group Democracy Forward Foundation and one of the lawyers in the case, said the outcome could have larger significance for other medications.

"There are industry wide implications if far-right external interest groups
are able to interfere with drug availability in the country without the legal and regulatory protections provided by Congress," Perryman said. "If this were to be the case, few companies would be incentivized to develop and bring essential medications to market."

Danco Laboratories, the original distributor of mifepristone in the U.S., has joined the FDA in the case and is asking the Supreme Court to block restrictions on the drug.

In a separate case filed earlier this year, GenBioPro also sued the state of West Virginia over its state abortion restrictions, arguing that federal regulations allowing the use of mifepristone should prevail over West Virginia's state laws.