Abstract
Soaring drug prices are one of the greatest challenges facing the American healthcare system today. Major contributing factors include the extended use of market exclusivity granted by the FDA and the abuse of the Orphan Drug Act beyond its original purpose. This Note will discuss the regulatory and legislative history of the FDA from its inception to its current state and use a comprehensive analysis of monoclonal antibodies to highlight the practical effects high drug prices have on patient care. Finally, this Note will provide recommendations to shift the regulatory and legislative approach surrounding the FDA away from favoring innovation to supporting competition in the drug market, thus improving accessibility.
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