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Goldwater Urges Court: Reject FDA’s Rush to Regulate Innovation

August 7, 2023

Can the Food and Drug Administration (FDA) regulate like a drug a purely medical procedure in which a person’s own cells are extracted and reinserted into the patient’s body without alteration? A federal district court in California rightly answered “no,” but the FDA has appealed that ruling, arguing that the agency should get to decide. Last week, the Goldwater Institute filed a brief urging the 9th Circuit Court of Appeals urging the court to reject the FDA’s overreach.

Although federal law entrusts the FDA with the regulation of drugs, it does not empower the agency to regulate the practice of medicine. The treatments in question essentially involve removing fat tissues from a patient, extracting the patient’s own cells from the tissue, and relocating those cells back into the patient’s body around an injured area. This is more akin to the kind of cosmetic surgery that involves removing fat from one part of the body and placing it in another, or the kind of heart surgery in which an artery is removed from the patient’s leg and used to replace a faulty artery in the chest. Such procedures are certainly subject to regulation—but they are subject to regulation as medical procedures, not as the administration of a new drug.

Why does it matter whether the treatment is regulated as a drug or a medical procedure? As a practical matter, subjecting a purely surgical procedure to FDA regulations intended for new drugs will needlessly force patients to wait—perhaps for years—to receive the treatment, and bar some of them from receiving it altogether. This is especially disturbing given that these procedures are some patients’ only alternative to major surgery and can be used to treat degenerative disorders that can be life-threatening. And these delays could hinder medical innovation, to the detriment of patients.

Moreover, subjecting a medical procedure to regulations intended for manufactured drugs would intrude into both the right of patients to decide for themselves what medical treatments to undergo and into the practice of medicine, an area historically regulated by the states.

Ensuring that the states retain their role in overseeing the practice of medicine is especially critical given the breathtaking growth in the FDA’s scope of power since its inception. When federal drug regulations were first adopted, they focused on ensuring that products marketed to the public at large were safe and correctly labeled. The goal was to give patients the truthful information they need to make informed decisions about the medicines they might take. Although federal law has gradually shifted to require the FDA to regulate not just safety, but also efficacy, Congress’ goal remains the same: to ensure that patients can, in consultation with their (state- regulated) physicians, make the best decisions possible for themselves—not to tell patients what they can and cannot do with their own bodies. Congress’ 2018 adoption of Goldwater’s Right to Try Act—which allows dying patients to try treatments that have passed basic safety testing but haven’t yet been approved by the FDA—restated this goal as the standard for federal regulation of medicine.

Deviating from this patient-centric regulatory system to allow the FDA to control medical procedures as if they were drugs would needlessly subject patients to a system that undermines individual choice and personal dignity, cede deeply personal decisions to bureaucrats, and leave patients to suffer. We will continue to fight for healthcare freedom and hope the 9th Circuit will ensure the FDA does not overstep its boundaries to the detriment of patients.

You can read out brief here.

Christina Sandefur is the Executive Vice President of the Goldwater Institute.



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