TY - JOUR AU - Alexander Snyder, PY - 2021/08/26 Y2 - 2024/03/29 TI - For Profit or For Health? It is Time to Reckon With the Current Pharmaceutical Landscape Through a Systematic Analysis of Monoclonal Anitbodies JF - Pittsburgh Journal of Technology Law & Policy JA - tlp VL - 21 IS - 2 SE - Staff Article Series DO - 10.5195/tlp.2021.251 UR - https://tlp.law.pitt.edu/ojs/tlp/article/view/251 SP - AB - <p>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.</p> ER -