A high-profile lawsuit targeting one of the two drugs used for medication abortion in the US threw Mifeprex (and the company behind it) into the national spotlight. But little is publicly known about Danco Laboratories, even 20+ years after it started to sell mifepristone tablets.
Unlike most drug companies, Danco—which is not publicly traded and employs fewer than 25 people—does not list its executives, investors, or even the address of its headquarters. Instead, it offers a New York City PO Box for its location (though some have previously described the office as being in “midtown” Manhattan).
Even federal documents surrounding the FDA’s 2000 approval of Mifeprex have reportedly been redacted to omit information on company employees and locations.
That secrecy, a Danco spokesperson said, is intentional.
Danco spokesperson Abby Long told Healthcare Brew that the decision to not share the company’s address publicly boils down to safety.
“There’s been concern on both the part of the company as well as the groups that we work with—our distributor and the manufacturers and so on and so forth—in terms of having their information out there publicly, and potential for being exposed to harassment or even violence to an extent,” she said. “The history of that kind of reaction to those who are doing anything to provide abortion care services is certainly well documented.”
Danco, which joins GenBioPro Inc as one of two companies that sells mifepristone in the US, has faced some pushback and threats “over the course of time,” Long said. But the lack of publicly available details about the company has likely helped shield it from in-person incidents.
New York City nonprofit Population Council transferred the rights to sell mifepristone—once federally approved—to Danco in 1997, the New York Times reported. French drugmaker Roussel-Uclaf had previously donated the rights to sell mifepristone in the US to the nonprofit in 1994.
Even before Danco began selling Mifeprex, the company had garnered a reputation for being “publicity shy,” sharing little about its plans for manufacturing, distributing, or marketing the drug (then known as RU-486) pending FDA approval, the Wall Street Journal reported in September 2000. The newspaper noted that Danco’s then-CEO Roy Karnovsky, a former Merck & Co executive, didn’t “talk to the press.”
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Meanwhile, the Washington Post described Danco as “one of the most enigmatic companies in the pharmaceutical industry.”
Court fight
Despite the company’s attempts to keep a low profile, in November 2022, Danco reentered the public eye after the Alliance for Hippocratic Medicine filed a federal lawsuit against the FDA over its approval of mifepristone.
Danco has argued in court documents that the case threatens the company’s “very existence,” as it only sells mifepristone. GenBioPro, which received FDA approval in 2019 to sell generic mifepristone, has also pushed back against efforts to restrict mifepristone access.
In April, Judge Matthew Kacsmaryk of the US District Court for the Northern District of Texas ordered a hold on the federal government’s approval of the drug. But a simultaneous ruling from another federal judge directed the government to not restrict access to mifepristone in at least 17 states and DC.
The conflicting orders elevated the case to the US Supreme Court, which ruled that the abortion pill could remain available as the lawsuit works its way through the Fifth Circuit Court of Appeals.
A three-judge panel heard oral arguments in May. The appellate court has yet to issue its decision in the case. Though when that ruling comes, it’s likely to be appealed back to the Supreme Court, according to NPR.
“Once that ruling comes down, that will inform what the next steps are going to be. We’ve certainly had discussions around all of the potential directions that [this] could go,” Long said. “We intend to continue to defend this product.”