Pharmacy 151 Introduction to Pharmacy Law US Legal System

Why Regulate Medications?  Potential risks to users  Free market not always efficient  Market inefficiency leads to “Market Failure”

Market Failures  Public Goods  National Defense Programs  Orphan Drugs and Vaccines  Externalities  Purchasing product from company that pollutes the air  Over use of antibiotics

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

Sources of United States Law  LEGISLATIVE  EXECUTIVE  JUDICIAL  ADMINISTRATIVE

Federal and Legislative Process  Constitution  Federal Statutes  State Constitution  State Legislation  Ordinances  Administrative Law

American Judicial System  Courts  Procedures  Selection of a Court  The Parties  Complaint, Summons, and Answer  Discovery  Pretrial Motions  Jury Selection

American Judicial System (Cont)  Witnesses  Trial  Verdict  Appeal

Administrative Agency Responsibilities  Rulemaking  Investigative  Adjudicatory  Enforcement

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

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

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)

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

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

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

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

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

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

Two major objectives of law  Substantive  Creates, defines, and regulates rights  Procedural  Prescribes methods for enforcing rights and obtaining redress