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Pharmacy 151 Introduction to Pharmacy Law US Legal System
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Why Regulate Medications? Potential risks to users Free market not always efficient Market inefficiency leads to “Market Failure”
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Market Failures Public Goods National Defense Programs Orphan Drugs and Vaccines Externalities Purchasing product from company that pollutes the air Over use of antibiotics
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Market Failures (cont) Natural Monopolies Utilities that provide electricity and water Exclusive right to market the drug Information Asymmetry See true value of good on examination Medications true values can not be seen
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Sources of United States Law LEGISLATIVE EXECUTIVE JUDICIAL ADMINISTRATIVE
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Federal and Legislative Process Constitution Federal Statutes State Constitution State Legislation Ordinances Administrative Law
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American Judicial System Courts Procedures Selection of a Court The Parties Complaint, Summons, and Answer Discovery Pretrial Motions Jury Selection
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American Judicial System (Cont) Witnesses Trial Verdict Appeal
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Administrative Agency Responsibilities Rulemaking Investigative Adjudicatory Enforcement
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Administrative Procedure Act Requires agency to: Prepare written regulations Publish them in Federal Register Hold hearings on proposed regulations Publish modified regulations Hold 2 nd hearings on modifications Publish final regulations before implementation
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Advantages of Administrative Agencies Develop expertise (legislature/executive lack) Public better served by use of experts Enhanced communications between regulators and regulated Have long-term knowledge on which to base decisions
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Advantages of Administrative Agencies (Cont) Can closely supervise judgment against regulated High profile discourages improper behavior Administrative process faster than trial Reduces court case load (costs)
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Disadvantages of Administrative Agencies High cost of operation Cost/benefit may be poor Salaries too low to attract true experts Government/private sector interchanges may not always serve the public interest (special interests) Too much power (judge, jury, & executioner Slow, inefficient, and poor results
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Divisions of Law: Civil Relates to disputes between two or more private parties Object is to compensate the injured party Penalties include damage awards, enforcement of contracts, or injunctions against action Tried before a court Torts, Contracts
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Divisions of Law: Criminal Society punishes individuals who commit crimes by violating specific statutes Object is to deter future behavior, punish the wrong doer (retributive justice), and/or rehabilitate the wrong doer Penalties involve fines and/or prison sentences, sometime capital punishment (death) Misdemeanors, Gross Misdemeanors, Felonies
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Divisions of Law: Administrative Investigations of violations of rules or regulation made by administrative agencies Directly affects only those individuals subject to the agency’s jurisdiction Object is to correct professional or business behavior, and/or to remove a person from a profession if he or she poses a danger to the public Involves hearings before the agency Results in payments of fines and/or probation, suspension, or revocation of license or other permit May be appealed to a court
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Relationship among Divisions Trials or hearings and penalties, conducted in one division of the law do not preclude trials, hearings, and penalties in another division In some cases, evidence in one division may be used in cases from an other division Example: Robert Ray Courtney
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Example: Robert Ray Courtney 20 Criminal Charges Tampering with consumer products (8) Adulteration (6) Misbranding (6) Unknown number of patients injured, who may sue MO Board of Pharmacy received surrendered license
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Two major objectives of law Substantive Creates, defines, and regulates rights Procedural Prescribes methods for enforcing rights and obtaining redress
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