PHP 316 Lecture Notes - Lecture 38: Prescription Drug User Fee Act, Prescription Drug Marketing Act, Medical Device Regulation Act
Document Summary
Chapter 1: the law and the legal system. Law: requirements for human conduct applying to all persons within their jurisdiction. Framework (inherently flexible) to make good decisions: reasons to regulate drugs, regulated due to potential risk to users. Investigational drugs may be used for treatment outside of phase 1,2, or 3 clinical tests for patients w/ life-threatening diseases for which no comparable or satisfactory alternative therapy is available provided certain conditions are met. Medicare federally provided health insurance, paid by taxes is 65 years and older certain disabled persons. Administered by cms centers for medicare and medicaid services 4 components. 2006 part d from mma medicare modernization act stupid. Patient protection and affordable care act obamacare. Part a has no premium, the rest do, costs a lot of money to be on medicare. Deductible have health insurances, you have to spend that much money before insurance kicks in. More than half preferred drug plans fail to meet gov threshold.
