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Under the settlement dated March 31 and released last week, Danco agreed to pay $765,000 to the U.S. to resolve allegations that, from 2011 to 2019, the company failed to both properly label imports of the drug as originating in China and pay customs duties on imports lacking those labels.
Under the deal, Danco denied the allegations leveled by the Life Legal Defense Foundation in a lawsuit filed in a Sherman, Texas, federal court back in January 2021. However, the drugmaker said it was settling to “avoid the delay, uncertainty, inconvenience, and expense of protracted litigation,” according to the agreement.
The DOJ’s April 12 press release about the settlement names Danco, but does not mention the now high-profile abortion drug at the center of the dispute, mifepristone.
“Danco is committed to operating ethically and legally and reaffirms that this case did not concern the safety or efficacy of Danco’s product,” the company said in a statement. “The settlement allows Danco to continue to focus on providing high quality, safe, and effective medication to women in the United States.”
Life Legal, a Napa, Calif.-based nonprofit group that opposes abortion, brought its suit under whistleblower provisions of the False Claims Act. That allows third parties to file challenges on behalf of the U.S. government and claim between 15 percent and 30 percent if the action is successful.
Life Legal will receive approximately $116,000 from Danco’s payments to the Justice Department over the next roughly nine months, according to the settlement.
In a particularly awkward provision for Danco, which was specifically founded to ease access to medication abortion by distributing mifepristone in the U.S., the drug firm agreed to pay over $46,000 directly to the anti-abortion organization to cover its legal fees and costs related to the suit.
The suit was filed nine days after Joe Biden was sworn into office in January 2021, seemingly setting up a showdown between a president who supports abortion rights and the drugmaker. In accordance with federal law, the complaint was kept under seal while the government investigated. A judge unsealed portions of the records earlier this month.
Last week, the Justice Department and Danco asked the Supreme Court to preserve access to mifepristone after a lower court suspended FDA approval of the drug. Justice Samuel Alito issued a short-term stay while the court considers the request.
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( With inputs from : www.politico.com )
