HSM 410 Week 7 Course Project 1 (Congress and Issues Regarding Specialty Pharmaceuticals)
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Congress and Issues Regarding Specialty Pharmaceuticals
Details of the Project
I. Specialty Pharmaceuticals
II. Legislation/policy analysis
A. Specialty Tiers.
B. Cost Sharing Burden.
III. Problem/issue addressed
A. Biosimilar Medications.
B. Generic Medications.
IV. History of the legislation
A. Drug Importation Act of 1848
B. Biologics Control Act of 1902.
C. Pure Foods and Drug Act of 1906.
D. Harrison Narcotic Act of 1914.
E. Food, Drug, and Cosmetic Act of 1938.
F. Amendments; Sherley Amendment of 1912, and the Humphrey Amendment of 1952.
V. Effectiveness in addressing the problem or issue
C. Ensuring the right medications get to the right people.
D. Responsibility of manufacturers, government, insurers, and physicians.
VI. Group(s) of people affected
E. Individuals with serious or chronic medical conditions.
VII. Future of this legislation
F. Growth in need for specialty pharmaceuticals.
G. Over-regulation of specialty pharmaceuticals.
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