{"id":328081,"date":"2025-04-16T10:48:05","date_gmt":"2025-04-16T15:48:05","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=328081"},"modified":"2025-04-30T11:41:19","modified_gmt":"2025-04-30T16:41:19","slug":"generic-abortion-pill-manufacturer-economic-interests-lawsuit","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/generic-abortion-pill-manufacturer-economic-interests-lawsuit\/","title":{"rendered":"Court grants generic abortion pill’s manufacturer permission to protect ‘economic interests’ in lawsuit"},"content":{"rendered":"
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UPDATE, 4\/30\/35<\/b>: On April 28, 2025, the judge ruled in favor<\/a> of GenBioPro’s request to intervene in the lawsuit, writing that “in its wide discretion, the Court GRANTS GenBioPro permissive intervention.”<\/p>\n

4\/26\/25<\/strong>: The U.S. generic abortion pill manufacturer controlling<\/a> roughly two-thirds of the abortion pill market has filed a motion to intervene<\/a> in a lawsuit that is challenging the expansion of the abortion pill. The company says the outcome of the case could cause “serious harm” to its “economic interests.”<\/p>\n

GenBioPro, according to a court document<\/a>, is the “sole supplier of generic mifepristone in the United States,” and its sales of generic mifepristone and misoprostol (the abortion pill regimen) “represent the majority of the company\u2019s revenue.”<\/p>\n

The name brand manufacturer of the abortion pill, Danco, is a competitor to GenBioPro, and has its own interests to protect in the lawsuit<\/a>,\u00a0Missouri et al. v. FDA<\/i>, filed by the State of Missouri, State of Kansas, and the State of Idaho in October 2024 in the U.S. District Court for the Northern District of Texas, Amarillo Division.<\/p>\n

The States claim<\/a> that their \u201csovereign\u201d interest in \u201cprotecting\u2026 citizens\u201d was violated by the U.S. Food and Drug Administration\u2019s (FDA) decision to allow the abortion pill to be dispensed via mail. These states chose to intervene<\/a>\u00a0and\u00a0file a complaint<\/a> after the U.S. Supreme Court ruled<\/a> that the original plaintiffs (a group<\/a> of pro-life physicians<\/a>) in the case [formerly known as Alliance for Hippocratic Medicine (AHM) v. FDA<\/i>], had no standing to sue.<\/em><\/p>\n

GenBioPro’s Motion to Intervene<\/strong><\/p>\n

As GenBioPro (GBP) claims in the Court document, the States are seeking an “order rescinding FDA\u2019s 2019 approval of GenBioPro\u2019s generic mifepristone as safe and effective for its intended use. The States also ask the Court to vacate other regulatory actions that impact the conditions under which mifepristone can be prescribed and distributed to patients, threatening serious harm to GenBioPro and the many Americans it serves,” because the sale of the abortion pill regimen “comprises the majority of GenBioPro\u2019s business.”<\/p>\n

“FDA is GenBioPro\u2019s regulator, and Danco is GenBioPro\u2019s competitor,” GBP added, noting that it filed the motion once it became “aware that its interests would no longer be protected” by Danco, which was the “original defendant.”<\/p>\n

GBP claimed that, since the original AHM lawsuit, “the nature of the threat to GenBioPro\u2019s interests has changed dramatically,\u201d as “the Amended Complaint discusses GenBioPro more than 25 times.” In short, the scope of the lawsuit’s complaint has changed considerably.<\/p>\n

While “Danco\u2019s interests and GenBioPro\u2019s interests were initially aligned when the Alliance Plaintiffs challenged… the Amended Complaint” by the three States “now alleges that the 2019 ANDA approval [of the generic abortion pill] was ultra vires and arbitrary and capricious under the Administrative Procedure Act (‘APA’) in its own right,” GBP noted, “separately targeting GenBioPro\u2019s 2019 ANDA approval on grounds unrelated to the 2000 Mifeprex approval.”<\/p>\n

GBP wrote that “… Danco\u2019s interest in this action now\u2014to protect post-2000 regulatory decisions addressing distribution of Mifeprex\u2014does not necessarily extend to protecting the approval of generic mifepristone produced by its competitor,” and it is now “obvious that the economic interests of [GenBioPro] are at stake.”<\/p>\n

Since this lawsuit would impact “GenBioPro\u2019s ability to market its product in the United States,” it is “a direct, concrete, and particularized threat to GenBioPro\u2019s economic interests that justifies intervention,” GBP claimed. “If the States\u2019 claims succeed and the challenged FDA decisions on mifepristone are vacated, GenBioPro may be hindered in marketing its primary product and face severe financial and operational distress.”<\/p>\n

GenBioPro is represented<\/a> in the lawsuit by a team of lawyers from the Democracy Forward Foundation (DFF) and Arnold & Porter, the same team which represented<\/a> the abortion pill company in the AHM case. DFF partners<\/a> with multiple pro-abortion groups such as Advancing New Standards in Reproductive Health (ANSIRH<\/a>), the American College of Obstetricians and Gynecologists (ACOG<\/a>), and Planned Parenthood. In past years, Warren Buffett’s abortion philanthropy via the Buffett Foundation (which invested<\/a> in the abortion pill early on) has granted<\/a> over $4 million to DFF.<\/p>\n

“If the judge grants GenBioPro\u2019s request, the maneuver will allow the company to lead the defense of mifepristone,” the New York Times claimed<\/a>.<\/p>\n

GenBioPro Holds Majority of Abortion Pill Market<\/strong><\/p>\n

A 2023 GenBioPro lawsuit<\/a> claimed that the company sold only \u201cgeneric mifepristone and misoprostol, which make up the FDA-approved two-drug regimen for medication abortion.\u201d Located<\/a> in Las Vegas, Nevada, GBP has claimed to ship a significant amount<\/a> of the life-ending abortion drugs across the nation. The company previously claimed that sales<\/a> from the abortion pill regimen are “essentially the company\u2019s sole source of product revenue\u201d and that it had\u00a0\u201ccaptured a significant share of the nationwide market for mifepristone.\u201d<\/p>\n

According<\/a>\u00a0to multiple\u00a0media<\/a> sources, GBP’s share<\/a> is massive, supplying roughly two-thirds<\/em>\u00a0of U.S. abortion pills.<\/p>\n

\u201cSince 2019, when GenBioPro received approval from FDA to sell generic mifepristone, GenBioPro has marketed and sold more than 850,000 units of the product throughout the United States,\u201d the company wrote<\/a> in 2023. \u201cBetween 2017 and 2020 (the year after GenBioPro began marketing its product), medication abortions in the United States increased by 45 percent, even as the overall number of abortions has declined since the 1990s. Medication abortion now accounts for the majority of pregnancy terminations in the United States.\u201d<\/p>\n

\"GenBioPro

GenBioPro only manufacturers one product: the generic abortion pill regimen<\/p><\/div>\n

Abortion Pill Expanded Quickly During Pandemic<\/strong><\/p>\n

The abortion pill (mifepristone 200mg<\/a>) was approved<\/a> by the FDA in 2000 for use in the termination of pregnancy with the drug misoprostol. Mifeprex was originally manufactured by Danco Laboratories<\/a>, but in 2019, the FDA approved<\/a> GenBioPro<\/a> as mifepristone’s generic manufacturer.<\/p>\n

Under a safety system called REMS, the drug was only permitted to be dispensed in-person by a certified prescriber (doctor or clinician). But in April of 2021<\/a>, under the guise of the\u00a0COVID-19 pandemic<\/a>, the Biden administration FDA\u00a0expanded<\/a>\u00a0the REMS and\u00a0temporarily<\/em>\u00a0enabled the limited\u00a0mail-order pharmacy<\/a>\u00a0distribution<\/a>\u00a0of mifepristone (the abortion pill).<\/p>\n

In December 2021, the FDA further weakened<\/a>\u00a0the\u00a0REMS<\/a>\u00a0by eliminating the\u00a0in-person dispensing requirement<\/a>\u00a0and enabling the abortion pill to be\u00a0permanently<\/em>\u00a0shipped by mail<\/a>.<\/p>\n

In January 2023<\/a>, the Biden FDA announced it would also\u00a0allow retail pharmacies to dispense the drug<\/a>.<\/p>\n

GenBioPro Funding<\/strong><\/p>\n

GenBioPro’s president<\/a>, Evan Masingill, was one of the first board members to join<\/a> the abortion facility<\/a> Desert Star Institute for Family Planning (DSIFFP) in 2017. That clinic was founded<\/a> by DeShawn Taylor<\/a>, one Planned Parenthood’s former abortionists<\/a>\u00a0recorded in\u00a0undercover video<\/a>\u00a0by the\u00a0Center for Medical Progress<\/a> admitting to committing abortions \u201cup to 24 weeks\u201d and needing to “hit the gym<\/a>” to do D&Es without first causing fetal death using digoxin. Taylor is now a senior medical director<\/a>\u00a0and\u00a0consultant<\/a> for GenBioPro, and claimed in a Dobbs v. Jackson<\/em> case Supreme Court brief<\/a> that \u201cabortion saves lives.\u201d<\/p>\n

GenBioPro has been funded<\/a> by the pro-abortion David and Lucile Packard Foundation, just like the originally approved and highly secretive<\/a>\u00a0abortion pill manufacturer\u00a0Danco Laboratories<\/a> (which received<\/a> $14.2 million<\/a> in startup investment dollars from Packard). According to a recent\u00a0IRS document<\/a> obtained by Live Action News, the Packard Foundation has invested<\/a> millions in GenBioPro<\/a>:<\/p>\n