Federal Regulation of the Pharmaceutical Industry- Exam 1 Flashcards Preview

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Food, Drug, and Cosmetic Act



  • A drug or device is adulterated if:
    • it consists of any filthy, putrid, or docomposed substance 
    • it has been prepared, packaged, or held under unsanitary conditions where it may have become contaminated
    • its container is composed of any poisonous or deleterious substance
    • it has an unsafe color additive
    • its quality or strength has been reduced by the addition or substitution of other substances


******FDCA History Continued

  • 1938: Federal Food, Drug, and Cosmetic Act (FDCA)
    • prompted by 107 deaths from sulfanilamide elixir, which was mixed w/ diethylene glycol (antifreeze)
    • new drugs must be proven to be safe (to the FDA)
    • pre-1938 drugs exempted from "safety" requirement (eg. ASA, warfarin)



  • A drug or device is misbranded if:
    • its labeling is false or misleading
    • its labeling is inadequate
    • it fails to have required statements prominently displayed & easily understood
    • its container is misleading
    • the manufacturer/distributor has not included the following in all labeling, descriptive matter, and advertising
      • generic name, formula with each ingredient and quantity, information on effectiveness, side effects and contraindications


******FDCA- What is a "Drug"?

  • DRUG means:
    • articles recognized in the US Pharmacopeia. Homeopathic Pharm. or National Formulary
    • articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
    • articles intended to affect the structure or any function of the body of man or other animals
    • articles intended for use as a component of one of the above 3 categories
    • no differentiation between Rx and OTC
    • manufacturer's intent= whether an article is a drug


*****FDCA Compounding

  • Compounding
    • State board regulated
    • prepared for 1 patient
    • immediate demand
    • [advertising of drug = ok] (Freedom of Speech issue)
    • exempt from NDA and current GMP
    • traditional pharmacy function


*****FDCA History

  • 1906: Pure Food & Drug Act
    • prompted by unsanitary practices in food & drug industries
    • prohibited adulteration and misbranding of foods & drugs
    • amended in 1912 to prohibit false & fradulent efficacy claims


*****FDCA Manufacturing

  • Manufacturing
    • ​FDA inspected and regulated
    • resale to 3rd parties
    • future demands
    • make inordinate amounts
    • distribute out-of-state
    • sell wholesale


****FDCA History- 1962

  • 1962: Kefauver-Harris Amendments
    • ​prompted by the "thalidomide disaster": European antinauseants, which caused 1000's of birth defects
    • drugs must be proven to be EFFECTIVE 
    • retroactive to drugs approved since 1938
    • established Good Manufacturing Practices (GMP)
    • required "informed consent" of research subjects in investigational drug trials


****FDCA History Continued

  • 1951: Durham-Humphrey Amendments
    • established 2 classes of drugs:
      • prescription (Rx)
      • over-the-counter (OTC)
    • authorized ORAL prescriptions and refills


****FDCA- Prohibited Acts

  • Most prohibited acts involve misbranding or adulteration
  • Violation of FDCA is subject to strict liability 
  • Applicable to pharmacies
    • The mere receipt and subsequent delivery of an adulterated or misbranded drug
    • The doing of any act which causes a drug to be counterfeit
    • The alteration, mutilation, etc. of the labeling


****FDCA- Rx Label Requirements

A prescription label MUST contain:

  1. ​Name and address of the pharmacy
  2. Serial number of the prescription
  3. Date of the prescription filling
  4. Name of the prescriber
  5. Name of the patient
  6. Directions for use
  7. Cautionary statements if indicated on the prescription


****NDA Process- Phase IV Studies

  • Phase IV Studies
    • ​FDAAA empowered FDA to require manufacturers to conduct Phase IV studies when adverse event reporting or active surveillance is inadequate


****New Drug Application Process- Post Marketing Surveillance

  • Post Marketing Surveillance
    • ​Required of manufacturer after NDA approval
    • Must submit to FDA reports of serious adverse drug reactions and any new information of safety and efficacy


****Out-of-State Rx

  • Usually Rx from other states is honored as a professional courtesy
  • Usually illegal to fill a Rx from a foreign country
  • Texas allows written Rx for non-controlled medications from Canada and Mexico


****Rationale for Federal Drug Regulation

  • Protection of the public against adulterated and misbranded drug products
  • Necessity of balancing "direct regulation" and "indirect regulation"


***Drug Price Competition (DPC) & Patent Term Restoration Act (PTRA) of 1984

  • Expedited generic approval process
  • Generic manufacturer must demonstrate:
    • same active generic ingredient
    • bioequivalence
    • acceptable manufacturing and control
  • Concessions to innovator drug companies included 
    • patent extensions
    • market exclusivity



  • Bioequivalence of generics to the parent and each other
  • Whether a drug without market exclusivity for a particular indication could be prescribed and dispensed for that indication
  • Whether FDA can approve and ANDA for a generic when the labeling will not include one or more of the indications contained on the innovator drug product's labeling


***FDCA History: 2009

  • 2009 FDA Guidance
    • ​off-label use: indications other than approved by the FDA
    • Manufacturers' promotion of drugs for off-label use subject to FDA restrictions
      • unabridged peer-reviewed articles published in scientific/medical journals not influenced by drug company
      • accompanied by: approved labeling, comprehensive bibliography, contrary publication, any known safety risk, conflict of interest


***FDCA- Label Requirements- Side Effects

  • Effective 7/1/09, Rx labeling must contain a "side effects statement"

"Call your doctor for medical advise about side effects. You may report side effects to the FDA at 1-800-FDA-1088"

  • The statement may be:
    • On a sticker attached to the vial
    • On the vial cap
    • On a separate piece of paper
    • In consumer medical information
    • In the FDA-approved Medication Guide


***FDCA- Label Requirements- MedGuides

  • MedGuides are required handouts to be given to patients for certain high-risk drugs each time the drug is dispensed
    • to help prevent serious adverse effects
    • to assist patient decision making
    • to assist patient adherence
  • FDA now requires about 200 drugs to have MedGuides, including 
    • NSAIDS
    • Anti-depressants
    • Narcotics


***NDA Process- Risk Evaluation & Mitigation Strategy (REMS)

  • Risk Evaluation & Mitigation Strategy (REMS)
    • ​FDAAA granted FDA authority to require REMS as a condition for approval of an NDA or postmarket when the FDA believes it necessary to ensure benefits outweigh risks
    • Under REMS authority FDA can require a variety of procedures ranging from Medication Guides to limiting the drug to specified settings for dispensing


***NDA Process- Postmarket Labeling

  • Postmarket Labeling
    • FDAAA gave FDA the authority to require manufacturers to add safety information or warnings postmarket


***Nonprescription Drug Labeling

  • User friendly format including pharmacological category or principal intended use, cautions and warnings, adequate directions for use, and a "Drug Facts" panel
  • Pharmacies that re-label or repackage must conform to the same labeling requirements as manufacturers
  • Professional OTC labeling may be published by manufacturers for indicaions not appropriate for lay diagnosis or treatment
  • Drugs that are both OTC and prescription exist when some indications can be labeled with adequate directions for use and some cannot


**FDCA- Prohibited Acts Continued

  • FDA enforcement of the FDCA
    • Injuctions
    • Criminal proceedings
    • Drug seizure
    • Warning letter


**Functions of FDA

  • Rulemaking
  • Issue guidance documents
  • Incorporate advice from standing advisory committees of outside experts


**New Drug Application Process

  • New Drug Application (NDA)
    • all "new drugs" must be FDA approved
  • Initiated by IND Request/ investigational new drug
    • preclinical animal incestigations re: toxicity, kinetics
  • Phase I: detect adverse effects; low # of subjects
  • Phase II: determine efficacy; limited # of subjects
  • Phase III: determine safety & efficacy in large # of subjects
    • double blind; control group w/ placebo


*Black Box Warning

  • Required in labeling when use of a drug may lead to death or serious injury
  • Required for about 450 prescription drugs


*FDA Drug Recalls

  • FDA Drug Recalls
    • ​Class I: product causes serious adverse effects or death
    • Class II: product causes temporary adverse effects on health
    • Class III: product not likely to cause adverse effects on health (ex: labeling problem)


*FDCA- Penalties

  • Penalties
    • 1st offense: 1 year in prison & $1000 fine
    • 2nd offense or fraud: 3 years in prison & $10,000 fine
    • Civil penalties: $50,000- $1M (after 2nd offense)