Pharmacy Law and Policy Study Guide

Reasons for Medication Regulation

  • Potential risks to users.

  • Protection from risky choices.

  • Market failure (public goods, externalities, natural monopolism, information asymmetry).

  • Preventing unnecessary use that impacts others.

  • Incentivizing new drug development.

  • Ensuring informed decisions about drug therapy.

Sources and Types of Laws in the U.S.

  • Supreme Law: U.S. Constitution and Bill of Rights.

  • State Constitutions: Each state has its own.

  • Common Law: Developed from judicial opinions.

  • Criminal/Civil/Administrative Law

  • Sources: Executive, legislative, judicial branches, administrative agencies.

  • Statutory Law

Federal and State Legislative Processes

  • Federal Level: U.S. Congress (Senate and HOR).

    • Bill development, sponsorship, committee review (critical stage), reports, calendar placement, debate, amendment, passage, presidential signature (or override of veto).

  • State Level: Similar to U.S. Congress but with differences.

    • Meets less frequently, committees may have less thorough hearings, legislative history may be limited.

U.S. Judicial System

  • Interprets the law.

  • Includes criminal and civil courts, and the Supreme Court.

Responsibilities of Administrative Agencies

  • Enacting regulations and making enforcement decisions through hearings.

Types of Liability

  • Civil Law: Relations between private persons/organizations.

  • Administrative Law: Rules/regulations enforced by government agencies.

  • Criminal Law: Charges brought by the state under its criminal laws.

Relationship Between Federal and State Law

  • Federal law preempts conflicting state laws.

Factors Courts Rely on

  • Market failures: public goods, externalities, natural monopolies, and information asymmetry.

Hierarchy of Statutes

  • Federal statutes.

  • State constitutions.

  • State legislation.

  • Ordinances.

Major Federal Administrative Agencies

  • CMS: Controls Medicare and Medicaid procedures/reimbursement.

  • FDA: Regulates drugs, food, and cosmetics.

  • FTC: Enforces fair business practices and antitrust laws.

  • DEA: Administers the Controlled Substances Act.

Legal Tests for Administrative Regulation Validity

  • Within agency authority.

  • Based on enabling statute.

  • Reasonably related to public welfare, health, and safety.

Judicial Review of Administrative Regulation

  • Applicable if a decision lacks substantial evidence.

Federal Register vs. Code of Federal Regulations

  • Federal Register: Proposed regulations, final regulations, government notices.

  • Code of Federal Regulations: Reviewed final regulations.

Proof in Civil vs. Criminal Cases

  • Civil: Preponderance of evidence.

  • Criminal: Beyond a reasonable doubt.

Default Judgment

  • Ruled in favor of plaintiff if defendant doesn't respond to complaint within given time.

  • Avoid by responding to complaint and summons.

Acronyms and Terms

  • Orphan Drug: Treatment for rare diseases ( $<$200,000 Americans).

  • CGMP: Current Good Manufacturing Practices.

  • DPC/PTRA: Drug Price Competition and Patent Term Restoration Act.

  • PDMA: Prescription Drug Marketing Act.

  • PDUFA: Prescription Drug User Fee Act.

  • NLEA: Nutrition Labeling and Education Act.

  • DSHEA: Dietary Supplement Health and Education Act.

  • FDAMA: Food and Drug Administration Modernization Act.

  • MDUFMA: Medical Device User Fee and Modernization Act.

  • FDAAA: Food and Drug Administration Amendments Act.

  • FDASIA: FDA Safety and Innovation Act.

  • GDUFA: Generic Drug User Fee Act.

  • BsUFA: Biosimilar User Fee Act.

  • DQSA: Drug Quality and Security Act.

  • FDCA: Food Drug and Cosmetic Act.

  • NIH: National Institute of Health.

  • FDARA: FDA Reauthorization Act.

  • MDA: Medical Device Amendment.

Shortcomings of The Pure Food and Drug Act of 1906

  • Failed to regulate cosmetics and devices.

  • Did not prevent false efficacy claims.

  • Did not require ingredient labels, directions, or warnings.

  • Difficult to enforce (proving intent).

Medications Before 1938 Ensuring Uniform Potency

  • Insulin and antibiotics (e.g., penicillin).

Medications Resulting in Tragedy Catalyzing Legislation

  • Sulfanilamide elixir.

  • Thalidomide.

Amendments Containing Delaney Clause

  • Food Additives Amendment of 1958.

  • Color Additive Amendments of 1960.

  • Delaney Clause: Prohibits approval of any food/color additive that might cause cancer.

Titles and Alternate Names of Amendments

  • Durham-Humphrey Amendment: aka Prescription Drug Amendment.

  • DPC/PTRA of 1984: aka Waxman-Hatch Amendment.

  • DQSA: aka Compounding Quality Act, Drug Supply Chain Security Act.

Prescription Drug User Fee Act

  • Manufacturers pay fees for NDAs and supplements for FDA review.

  • Reauthorized every 5 years.

21st Century Cures Act of 2016

  • Accelerated drug approval for high-risk diseases.

  • Allows more patient experience data.

  • Risks: Potential danger in expedited drug approval because of lack of knowledge of long-term impacts.

Direct vs Indirect Regulation

  • Indirect Regulation: Helps people make their own decisions.

  • Direct Regulation: Makes decisions for people.

Act Requiring REMS

  • Food and Drug Administration Amendments Act of 2007.

FDCA Key Points

  • 1938 law: Drugs must be proven safe before marketing, labeling must contain directions and warnings.

  • Durham-Humphrey Amendment: Established prescription and OTC drug classes.

  • Kefauver-Harris Amendment (1962): Added efficacy requirement, retroactive to 1938.

  • Orphan Drug Act (1983): Incentives for rare disease drug development.

  • DPC/PTRA (1984): Generic drug approval process facilitated, patent extensions for innovator drugs.

  • PDMA (1987): Requirements for drug sample distributions, resale restrictions.

  • PDUFA (1992): Manufacturers pay application fees.

  • DSHEA (1984): Created dietary supplement class, regulated more as food than drugs.

  • FDAMA (1997): Streamlined drug approval, fast-track process for serious diseases.

  • FDAAA (2007): Enhanced FDA authority to regulate drug safety, including REMS.

  • FDASIA (2012): User fees for generic drugs and biosimilars.

  • DQSA (2013): Clarified compounding law, outsourcing facilities, track and trace requirements.

  • Cures Act (2016): Streamlined approval, more patient experience data.

  • Goal: Public protection; trend away from direct regulation.

FDA Organization

  • FDA regulates:

    • food, drugs, dietary supplements, cosmetics, devices.

Definitions

  • Food: articles used for food or drink for man or other animals, chewing gum, articles used for components of any such article

    • Drug: (1) articles recognized in the USP, HPUS, or DF; (2) intended for diagnosis, cure, mitigation, treatment, or prevention of disease; (3) articles (other than food) intended to affect the structure or function of the body; (4) articles used in the components of the above.

  • Dietary Supplement: Intended for ingestion to supplement diet, containing vitamins, minerals, herbs, amino acids, dietary substances.

  • Cosmetic: Articles for cleansing, beautifying, promoting attractiveness; components of such articles, except for soap.

  • Device: Instrument, apparatus, implement, machine, etc., recognized in NF or USP; intended for diagnosis or treatment; intended to affect body structure/function; not achieving its purpose through chemical action or being metabolized.

  • Label: Display of written, printed, or graphic matter on the immediate container.

  • Labeling: All labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers or any accompanying article.

Key Points of FDCA

  • Make sure ingredients match label

  • Recognize the prohibited acts, penalties, and enforcement mechanisms

  • Identify the situations that may cause a drug to be adulterated or misbranded.

  • Differentiate FDCA requirements for prescription drugs from those for over-the-counter (OTC) drugs.

Acronyms

  • CDER: Center for Drug Evaluation & Research

  • DHHS: The Department of Health & Human Services

  • EDS: Ephedrine alkaloid dietary supplement

  • NF: National Formulary

  • USP: United States Pharmacopeia

  • USPC: United States Pharmacopeial Convention

  • HPUS: Homeopathic Pharmacopoeia of the United States

Enforcing Agency

*FDA under DHHS

Definitions

*Different categories of food and drug

USPC

*organization and members
*relevance to FDCA

Recalls

  • severity by class

  • recall process, expectations on seller and manufacturer
    Class I recalls are issued when there is a reasonable probability that the product will cause serious adverse health consequences or death. Class II recalls occur when the product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse consequences is remote. Class III recalls apply to products that are not likely to cause adverse health consequences.

Professional Information

  • when is it appropiate

  • package insert

Unit Dose

  • items not required on label

New Drug Approval Issues

*Expensive and lengthy process. What is considered new drug? Unapproved drugs on the market
Grandfathered to pre 1938? Marketed w/out NDA? FDA doesnt approve OTC individually.
Treating serious and life threatening diseases
Biologics from other FDCA products
MedWatch program
Medical devices under FDCA
Advertising Regulations

Acronyms

List all acronyms for the reading

IND clinical trials

Identify the primary purpose of each phase

Application Details

PTRA Impacts

Educational Activity Evaluation

List the factor to evaluate

Statute Violation

Identify the statute when not complying with the OIG Compliance Program Guidance for Pharmaceutical Manufacturers

Free Speech

Identify the U.S. Constitution Amendment which guarantees the right of free speech

Advertising

Interactions

List the prohibition in PhRMA’s Code on Interactions with Healthcare Professionals.

New Drug Approval

Must submit evidence that drug is safe and effectiveTested in animals and humansBefore drug can be shippedIND application follows testing that prove the compound will be safe to test in humanMUST SUBMIT IND
Investigational New Drug ApplicationIND purposes are to protect the safety of the humans participating in the trialsand to ensure that the clinical trials are designed properly
Preclinical Trials:on animals, in-vitro, etc., to prove will be safe to test in humans then may submit an IND
Phase 1:ADME, safety, adverse effects, healthy patients
Phase 2:safety, dose, sick patients
Phase 3:double-blind study, lots of sick patients, efficacy then may submit an NDA
Public Registry of Clinical Trials
Requires informed consent from the patient or a representative in all 3 phases of clinical trials,
New Drug ApplicationComplete evaluation of drug safety and efficacy.

Supplemental NDAs

postmarketing survelliance
REMS

DTC advertising

Drug products advertising
Discuss with healthcare professionals and/or patients

Prescription and OTC Drugs

Rx= unsafe without Dr, or subject to NDA approval, OTC=FDA certified safe without supervision and labeled appropriately.

Durham-Humphrey

Legalized prescriptions refills, created rx and OTC drug classes, exceptions for drugs prescribed pursuant to an order.

MedGuides

MedGuides for drugs of serious concern. Required of oral contraceptives, drugs with estrogen, and DES

Liability

Dispensing for off-label use that puts significant/unreasonable harm to one

Orange and Purple Book

Orange Book: drugs approved as safe/effective. Purple Book: biologics, biosimilars, evaluates interchangeability.s

PDMA

Prescription Drug Marketing Act.

PPPA

Child resistant caps, patient must make blanket statement requesting non-compliant. Drugs exempted are nitroglycerin, isosorbide dinitrate.

Liability

Potential legal issues

Terms

Definitions
OBRA 90 goals and practice standards
Pharmacies must be in compliance
HIPPA etc

Controlled Substances CSA Act

Schedules CI-CV, DEA, regulations
Pharmacies dispensing must register
State Marijuana laws differing from federal.

Definition of a Narcotic

Registration

Who is exempt from registering with the DEA. What paperwork is needed to be filled out when transferring controlled substances
14 days in advance of planned transfer unless waived by special agent. 106 forms, DEA224a, DEA225 forms.
Storage must be secured, theft reported in writing for DEA Form within one business day