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Abstract

This Note will argue that, unlike what many patients believe, the U.S. Food and Drug Administration (FDA) plays an invaluable and imperative role in seeking the efficacy and safety of new treatment options and drugs. The balance of interests between those who are terminally ill, who wish to see increased access to unapproved medicines; the general public, who has an interest in preserving the drug approval process; and the FDA, who has been mandated by law to safeguard the safety of the general public, creates a tension that will continue to go unresolved. Thus, the patients who continue to advocate for routes outside of the FDA regulatory process—threatening to diminish the strength of the FDA’s presence and to remove many new, unapproved drugs from the FDA’s jurisdiction—place the future of drug development and regulation in peril. The FDA’s role should not be eradicated, but instead it should be bolstered and preserved. Public health crises prove not that drug regulation is overly cumbersome, unnecessary, and a death sentence for patients, but rather that there has never been more of a reason to preserve the role the FDA has received by law.

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