GenBioPro Intervenes in Mifepristone Lawsuit – FDA Approval Challenged

by Marcus Liu - Business Editor
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GenBioPro Intervenes in Mifepristone Lawsuit, Defending FDA Approval

Wichita Falls, Texas – GenBioPro, the manufacturer of generic mifepristone, a medication approved by the U.S. Food and Drug Administration (FDA) for the termination of early pregnancy, has filed a motion to intervene and a motion to dismiss in the case of Florida et al. V. FDA in the U.S. District Court for the Northern District of Texas, Wichita Falls Division.

Protecting Access to Essential Medication

GenBioPro’s decision to intervene stems from the lawsuit’s challenge to the FDA’s approval of generic mifepristone. The company asserts that abortion medication is essential healthcare for millions of Americans. “The relentless attacks on mifepristone’s FDA approval ignore decades of scientific evidence confirming the medication’s safety and efficacy, and disregard the millions of Americans who rely on it for essential care,” stated Evan Masingill, CEO of GenBioPro. “Health care decisions belong with patients and their providers – not politicians. GenBioPro remains committed to using all legal and regulatory tools to protect access to mifepristone for millions of patients and providers across the country.”

The Florida and Texas Lawsuit

The complaint filed by the states of Florida and Texas seeks to eliminate nationwide access to mifepristone by reversing the FDA’s initial approval in 2000 and subsequent decisions regarding the drug. Despite the established safety profile of mifepristone, supported by extensive scientific literature and real-world use, the lawsuit poses a threat to access for all Americans.

Legal Representation and Support

GenBioPro is represented in the suit by Democracy Forward Foundation and Arnold & Porter. Skye Perryman, President and CEO of Democracy Forward, emphasized the coordinated nature of challenges to mifepristone access, stating, “The lawsuit that Texas and Florida filed is just the latest in a series of copy-and-paste challenges designed to weaponize our court system and eliminate access to medication abortion that has long been proven safe…These coordinated attacks on mifepristone attempt to impose an extreme political agenda that would never stand a chance in the democratic process.”

GenBioPro’s Commitment to Reproductive Healthcare

Founded on the principle that all individuals, regardless of socioeconomic status, race, or location, deserve access to reproductive healthcare, including medical abortion, GenBioPro is proactively seeking to intervene in this litigation to safeguard access to mifepristone for all.

GenBioPro’s motion to intervene and motion to dismiss can be found here and here, respectively.

About Democracy Forward Foundation

Democracy Forward Foundation is a national legal organization dedicated to advancing democracy and social progress through litigation, policy, public education, and regulatory engagement. More information is available at www.democracyforward.org.

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