VENICE, Fla. (May 12, 2023) — The United States Medical Association (USMA) filed an amicus brief on Friday in the United States Fifth Circuit Court of Appeals in support of the Alliance for Hippocratic Medicine (AHM) and the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG.) On Monday, the Court accepted the filing.
The case stems from the Plaintiffs’ concerns regarding the many irregularities displayed by the Food and Drug Administration (FDA) in granting initial authorization for mifepristone and the numerous, subsequent irregularities in loosening the drug’s prior restrictions.
“The FDA has displayed significant and recurrent discrepancies with respect to federal law and its own procedural processes,” said Dr. Julio Gonzalez, USMA Founder, President, and co-author of the USMA’s amicus brief. “Ultimately, these place patients at great risk and jeopardize physicians who trust the decisions made by the single overseeing agency chartered with determining the safety and efficacy of a medication.”
As part of its investigations on the matter, the USMA discovered multiple examples where the FDA cut corners that either led to patient deaths or called into question the integrity of its oversight process. Cited in the brief were the public’s experience with Vioxx and, more recently, the FDA’s handling of aducanumab (Aduhelm), which Congress has recently called into question. In fact, on Monday, Bloomberg reported the apparent impropriety of the FDA’s “rapid approval process,” which, it observed, is
filtering billions of dollars to Big Pharma absent sufficient evidence of benefiting patients.
“This case is about much more than mifepristone,” Gonzalez said. “It’s about the need to maintain the integrity of a drug oversight process upon which patients and physicians alike must faithfully rely.”
As stated in the USMA’s amicus brief, neither a medication’s popularity nor its perceived safety and efficacy can absolve an overseeing agency from complying with its regulatory requirements of ascertaining that approved medications are fully vetted and ready for distribution. Anything less simply works to weaken our healthcare system and risk the lives and safety of America’s patients.
For more information, please visit us at usmedicalassociation.org