pharmacy law Flashcards
definition of law
Requirements for human conduct applying to all persons within their jurisdiction
Factors courts commonly apply in reaching decisions:
– Fundamental notions of fairness
– Custom or history involved
– Command of a political entity
– Best balance between conflicting societal interests
reasons to regulate drugs
market failures:
– public goods
– externalities
– natural monopolies
– info. asymmetry
public goods
Necessary and beneficial commodities that private entities will not supply because there is no incentive/financial return
example: orphan drugs & vaccines
what is a market failure
when there is an inefficient distribution of goods and services that leads to a lack of equilibrium in a free market.
orphan drug
is a pharmaceutical agent that is developed to treat certain rare medical conditions
externality
When the production or consumption of a good affects someone who does not fully consent to the effect
When the costs of the good are not fully incorporated in the price of the good
– Example: indiscriminate use of antibiotics
monopoly
When the fixed costs of providing a good are high, relative to the variable costs of producing the good
– Example: patents and market exclusivity for new drugs
info. asymmetry
When the consumer is uninformed about the true value of a good
– Examples: prescription only drugs; written consumer information for certain drugs
limits of the law
Certain human relationships
* De minimis violations
*Protecting individual freedoms while preventing harm to others
sources of the law
U.S Constitution
legislatures
administrative agencies
courts
legislatures: statutory law
U.S.Congress(federal laws)
State constitutions
State legislatures (state laws)
Political subdivisions (ordinances)
law made by admin. agencies
admin, agencies are created by legislatures to admin. a body of substantive law
Law Made by Administrative Agencies:
Legislative Function
Promulgateregulations
– Regulations interpret, define, and add detail to statutes.
* Regulationsenactedvianoticeandcomment rulemaking
* Validitytestsofaregulation:
– Within scope of board’s authority – Based on statutory authority
– Reasonable relationship to public health, safety, and welfare
Law Made by Administrative Agencies: Judicial Function
Render decisions pursuant to “hearings” resembling court proceedings
- Decisions subject to judicial review
– The court will review record to determine if
decision was based on substantial evidence.
– De novo: If substantial evidence is lacking, court will conduct an entirely new trial.
Federal Agencies
Regulations published in Federal Register(Fed.
Reg.) and Code of Federal Regulations (CFR)
– Federal Register: daily publication of proposed
and final regulations and notices
– CFR: compilation of final regulations divided and indexed by subject matter
Law Made by Courts: Common Law
Common law refers to judicial opinions; adopted from the English judicial system
* Judicialopinions:decisionsofthecourt
– Enforceable as law
– Binding on lower courts in the same jurisdiction
* Staredecisis
– Opinions are binding on lower courts in the same
jurisdiction and serve as precedent.
– Reasons for deviating from precedent include factual distinctions and changing times or circumstances.
Relationship of Common Law to Statutory Law
Courts often must interpret the meaning and application of statutes.
* Principles of interpretation include:
– Determining legislative intent, if possible – Ordinary meaning of words
– Due process rights of the individual
Distinguishing Criminal, Civil, and Administrative Actions
Criminal: government v. private party
– Charged with a crime as prohibited by a statute and
subject to penalties specified by statute
– Objectives: deter, punish, rehabilitate
* Civil:privatepartyv.privateparty
– May be based upon statute or common law legal rights – Objective: compensation to injured party
* Administrative:agencyv.privateparty
– Disciplinary determination which may include warning, fines, licensure revocation or suspension, probation
Legislative Process:
Federal Level
Congress – Senate
Legislative Process:
Federal Level (1 of 2)
– House of Representatives
* The sponsor of a bill must be a legislator.
* The bill is sent to appropriate congressional committee.
– Holds hearings, conducts investigations
– Determines whether bill will go to Senate or House floor
After the bill leaves the committee, majority leadership places the bill on a calendar.
* The bill must be debated and passed in one chamber before being sent to other chamber for debate and passage.
* The conference committee must rectify differences.
* Role of the president
– Approve or veto bill
* Congress can override veto with two-thirds
Legislative Process: State Level
State legislatures generally modeled after
Congress
* Legislative history generally harder to determine because fewer written records of committee hearings and reports
The Judicial Process: Federal Court System
U.S Supreme Court
– Highest U.S. court. Nine justices; lifetime appointment
– Original jurisdiction only in cases involving ambassadors, other public ministers, consuls, and when a state is a party
– Other cases heard by writ of certiorari * Courtofappeals
– 12 judicial circuits and courts; primarily hear appeals * Districtcourts
– Jurisdiction primarily based on whether there is a federal law or constitutional issue; diversity citizenship; or if a state or the U.S. is a party
* Specialty courts
State Court System
State supreme court
– Each state has one
* Intermediate appellate courts
– In more populated states * Trialcourts
– Often called county courts, superior courts, district courts, or circuit courts
– Nearly unlimited jurisdiction
* Limited jurisdiction courts: i.e., probate, family, juvenile * Very limited jurisdiction courts:i.e., traffic, small claims
Civil Court Procedures: Selection of Court
State court likely unless:
– Federal issue is involved
– Parties are from different states
Civil Court Procedures: Parties
Plaintiff: person bringing the action
* Defendant: person action is brought against
* Plaintiff’s name appears first in title of case
* Plaintiff must prove“ standing”
– The challenged conduct has caused the plaintiff injury.
– There is a legally protectable interest.
Civil Court Procedures: Statute of Limitations
- Limits the period of time in which a case can be filed
Civil Court Procedures: what are Summons, Complaint, and Answer
Summons: issued by court notifying defendant of suit and commanding defendant to file an answer
- Complaint: contains all material facts of case and remedy requested
Answer:admittingtoordenyingallegations – Default judgment if answer not filed
Civil Court Procedures: Discovery
Pretrial process in which each side must give the other all facts, evidence, and names of witnesses upon which it will rely
* Deposition:out-of-courttestimonybyawitnessunder oath
Civil Court Procedures: Jury Selection
Voir dire examination: the questioning by each side of potential jurors
The jury’s role is to determine questions of fact.
*The judge must determine questions of law.
Civil Court Procedures: Witnesses
Witnesses
– May be subject to subpoena, an order to appear in
court
– Failure to appear may result in contempt of court.
* Expert witnesses
– Called when the factual subject matter is beyond the scope of jurors
Civil Court Procedures: The Trial
Motion for summary judgment: one party attempts to convince the judge that the claims of the other side have no merit, even if correct.
Motion for directed verdict: after the introduction of evidence, one party alleges that the other lacks sufficient evidence.
- Objections: attempt to restrict the introduction of evidence or testimony; might constitute issues of law for appeal
- After all evidence is presented, the judge instructs the jury as to the applicable law.
Civil Court Procedures: Verdict and Appeal
Judgment notwithstandingtheverdict (NOV):the judge may rule contrary to the jury if the jury clearly reached the wrong verdict.
* A mistrial maybe granted if a major error or violation of law or procedure occurred during the trial.
* Either party may appeal the final verdict based on an error of law.
* For an appeal, attorneys submit a “brief” to the court, citing the legal principles and precedent involved and why the lower court erred.
Criminal Court Procedures
A defendant can be either indicted or arrested.
* Indictments are issued by a grand jury when it determines that enough evidence exists for an arrest and trial.
* If arrested, the judge must determine at a preliminary hearing if there is enough probable cause for an arrest; if so, the defendant must enter a plea at an arraignment.
* The parties may agree to a“plea bargain,”in which the defendant agrees to a lesser charge rather than face a trial.
* Burden of proof is“beyond a reasonable doubt,”rather than a “preponderance of the evidence” as in a civil trial.
Case Citations
State and federal appellate court decisions are often reported and have citations.
* From the citation, one can tell the names of the parties, which court decided the case, and the volume and page number where the case can be found.
Federal Versus State Law
When federal and state law conflict, federal law will preempt state law under the Supremacy Clause of the U.S. Constitution.
* Conflicts generally exist when state law is less strict than federal law.
* Federal authority to regulate drugs generally arises from the Interstate Commerce Clause of the U.S. Constitution.
* State authority to regulate generally derives from the Tenth Amendment to the U.S. Constitution and under its inherent police powers.
* State laws must bear a reasonable relationship to the public health, safety, and welfare.
Historical Overview of the Act part 1
Pure Food and Drug Act(1906)
- Food, Drug ,and Cosmetic Act(1938)
- Durham-Humphrey Amendment(1951)
Food Additives Amendment(1958)
Color Additive Amendments(1960)
Kefauver-Harris Amendment(1962)
Historical Overview of the Act
Medical Device Amendments(1976)
Orphan Drug Act (1983)
Drug Price Competition Act(1984)
Prescription Drug Marketing Act(1987)
Safe Medical Devices Act(1990)
Generic Drug Enforcement Act(1992)
Prescription Drug User Fee Act (1992)
Nutrition Labeling and Education Act(1990)
Historical Overview of the Act part 3
Dietary Supplement Health and Education Act(1994)
Food and Drug Administration Modernization Act(1997)
Medical Device User Fee and Modernization Act(2002)
Food and Drug Administration Amendments Act(2007)
Patient Protection and Affordable Care Act(2010)
FDA Safety and Innovation Act(2012)
Drug Quality and security Act(2013)
The 21st Century Cures Act(2016)
FDA Reauthorization Act (2017)
Federal Food and Drug Administration (FDA)
Housed under the Department of Health and Human Services (DHHS)
* Authority for administering the FDCA
* FDA secretary appointed by president with confirmation of Senate
Structure of FDA
what are the 4 offices under commissioner
National headquarters and extensive field force * Five offices under commissioner:
– Office of Foods and Veterinary Medicine
– Office of Global Regulatory Operations and Policy
– Office of Medical Products and Tobacco
– Office of Operations
– Office of Policy, Planning, Legislation and Analysis
Office of Medical Products and Tobacco
Center for Drug Evaluation and Research(CDER) * Center for Biologics Evaluation and Research
* Center for Devices and Radiological Health
* Center for Tobacco Products
* Oncology Center of Excellence
* Office of Special Medical Programs * Patient Affairs Staff
Functions of FDA
Rulemaking
* Issue guidance documents
* Incorporate advice from standing advisory committees of outside experts
What Is a Drug?
Articles recognized in the USP or homeopathic pharmacopeia
* Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease (Part B)
* Articles other than food intended to affect the structure or function of the body (Part C)
* Definition is intentionally broad to include almost anything with an intended therapeutic purpose or purpose of altering the structure or function of the body
Evidence a Product Is a Drug
Labeling
* Advertising
* Natureofproduct
