Pharmacy Law Exam 1

Food, Drug, and Cosmetic Act 1938

• Products are safe when used in conditions set by the label

Durham-Humphrey Amendments aka “Prescription Drug Amendments”

• Distinguished OTC from Rx drugs

  • OTC → adequate directions for use

  • Rx → adequate information for us

• Prescription drugs must have “Rx only” labeled

Drug Amendments of 1962 (Kefauver-Harris Act)

• Mandated standard good manufacturing processes

• Required informed consent

• Clinical trials must show efficacy

  • Had to review efficacy more 4300 drugs placed in market between 1938 and 1961

    • (Drug Efficacy Study and Implementation - “DESI”)

Orphan Drug Act

• Drugs for diseases with <200,00 patients

• Congress gave incentives:

  • Market exclusivity (patent)

  • Tax breaks

Drug Price Competition and Patent Term Restoration Act aka Waxman-Hatch Amendments

• Developed the Abbreviated NDA or ANDA

  • generics do not need to prove safety and efficacy through clincial trials because the original NDA already proved it

  • They must however prove bioequivalence

Prescription Drug Marketing Act 1987

• Banned reimportation of Rx medications

• Banned samples

• Banned resales from hospitals

• licensed wholesalers

Prescription Drug User Fee Act (PDUFA) 1992

• Allows collection of user fee for expedited review of an NDA

• Has to be reauthorized every 5 years

FDA Amendments Act (FDAAA)

• FDA authority to require phase 4 post clinical studies

• Require “risk evaluation and mitigation strategies (REMS) for drugs with unaddressed risk

  • Medguides, restricted distribution

  • new labeling to call doctor for advice or to report side effects

Affordable Care Act of 2010

• Included the biologics price competition and innovation act

  • designed to promote generic competition to complex molecule medications

    • AB, proteins, etc..

  • targeted drugs not covered by Waxman-Hatch

• Requires additional clinical trials

US vs. Sullivan

Established the FDA’s power of authority over interstate commerce

Drug

• Recognized in an official compendia

• Used in the diagnosis, mitigation, treatment, or prevention of disease

• Article (other than food) used to affect structure or function of the body

New Drug

• Drug not recognized by the FDA and is not generally recognized as safe or effective

Label

• Written, printed, or graphic on the immediate container of the container

Labeling

• Contains label

• All other written, printed, or graphic matter upon its container, wrapper or accompany

Adulterated

• contains filthy, putrid, or decomposed substance

  • packaged in unsanitary conditions

• Strength, purity, or quality differs from the standard

• Mixed or packed as to reduce its strength or quality

Misbranded

• Labeling is false or misleading

• Is missing any required labeling

• Counterfeit or meant to imitate and mislead as another drug

• Violation of poison prevention act

Phase 1 Trials

• Small number of volunteers (20-100)

• Test for kinetics and ADR’s

Phase 2 Trials

• Several hundred patients

• Contains patients with target disease

Phase 3 Trials

• 1,000s of patients

• Assess safety and efficacy

Supplemental New Drug Application (SNDA)

• Required whenever a manufacturer changes some aspect of the product, labeling, or substantive aspect of the product

  • Ex. new indication, new ADR, new manufacturing process, Rx to OTC, etc..

Abbreviated New Drug Application (ANDA)

• Same active ingredient

• Bioequivalent to brand name

• Manufacturing meets FDA standards

Authorized Generic

• Generic produced by the brand-name manufacturer

• They do not need to file an ANDA

Improved Generics 505(b)(2) NDA

• Established by Waxman-Hatch

• Not brand new nor generic

• New dosage forms, combinations, or delivery form, indication (alternative to SNDA)

• Additional clinical trials are necessary

  • gain exclusive right to market for 3 - 5 years

Dietary Supplement Health Education Act (DSHEA)

• Reclassified a huge class of substances into dietary supplements that were exempted from FDA regulation

• FDA can only regulate dietary supplements if there is significant or unreasonable risk of illness under normal use

Dietary Supplements

• Intended to supplement the diet

• Contains one or more:

  • vitamin, mineral, herb/botanical, amino acid, dietary substance

• Intended for oral ingestion

• Not represented as conventional food or sole item of a meal

• Labeled as dietary supplement

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