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The Food and Drug Administration

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Title: The Food and Drug Administration


1
Chapter 16
  • The Food and Drug Administration

2
FDA Prehistory
  • 1862, President Lincoln appointed first director
    of Department of Agriculture
  • 1883 Request for petition to pass laws
    prohibiting adulteration misbranding of foods
    and drugs.
  • For serious drinking, the drugstore was the place
    to go. Lydia E. Pinkham's Vegetable Compound, a
    popular nostrum for women, was depending on the
    formula, 15 to 20 percent alcohol (VU).

3
Advertising Cards
  • A common method for medicine-makers to hawk their
    products was to provide druggists with
    postcard-sized advertisements with a picture on
    one side and a description of the glories of the
    product on the other.
  • Ayer's Sarsaparilla
  • Dr. Morse's Indian Root Pills
  • Hires' Root Beer
  • Lydia E. Pinkham's Vegetable Compound (First
    Card)
  • Lydia E. Pinkham's Vegetable Compound (Second
    Card)
  • Pond's Extract
  • Rumford Yeast Powder
  • Wells, Richardson, Co.'s Lactated Food

http//www.mc.vanderbilt.edu/biolib/hc/nostrums/ca
rds.html
4
The Jungle, Upton Sinclair, 1906
  • with the hot weather there descended upon
    Packingtown a veritable Egyptian plague of flies
    there could be no describing this--the houses
    would be black with them. There was no escaping
    you might provide all your doors and windows with
    screens, but their buzzing outside would be like
    the swarming of bees, and whenever you opened the
    door they would rush in as if a storm of wind
    were driving them. (Chapter 10)

5
FDA History
  • 1906 FDA formed, banned interstate commerce in
    adulterated misbranded food, drink, and drugs
  • 1938 107 deaths of (primarily) children due to
    ingestion of Elixir of Sulfanilamide, a toxic
    combination of diethylene glycol and sulfa.
  • gt1938 Federal Food, Drug and Cosmetic Act

6
FDA Act 1938
  • requiring that new drugs be shown to be safe
    before marketing.
  • extending FDAs control to cosmetics and
    therapeutic devices.
  • authorizing factory inspections and standards of
    identity for food staples.
  • eliminating a requirement to prove intent to
    defraud in drug misbranding cases.
  • adding court injunctions to the previous
    penalties of seizures and prosecutions

7
Drug Testing Guidelines
  • Chemical Composition
  • Acute toxicity studies in two species
  • Chronic toxicity studies with different doses in
    different species
  • Observation of animals
  • Pathological examination of animals
  • Studies on the absorption and elimination of the
    chemical
  • Study of interactions
  • Knowledge of idiosyncrasies and untoward
    reactions

8
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9
(No Transcript)
10
FDA History Continued
  • 1962 sale/use of thalidomide banned in U.S. based
    upon thousands of birth defects, primarily in
    Europe South America amendment for efficacy
    safety
  • 1969 hearings re injuries (10,000) deaths
    (731) in a 10 year period heart valves,
    pacemakers, IUDs, (Nader)

11
FDA History Continued
  • gt 1976 Medical Device Amendments newgt review,
    oldgtgrandfathered, new equivalentgtgrandfathered
  • gt1978 Good Manufacturing Practices
  • gt1984 Medical Device Reporting
  • gt1988 Device Recall/Rebuild
  • gt1990 Safe Medical Devices

12
FDA History Continued
  • gt1992 Medical Device Amendments tracking,
    surveillance, reporting, refund, ..
  • gt1997 Modernization Act public health is a
    responsibility shared by the entire health care
    community. The law directs the agency to carry
    out its mission in consultations and cooperation
    with all FDA stakeholders, including consumer and
    patient groups, the regulated industry, health
    care professionals, and FDAs regulatory
    counterparts abroad

13
Labeling
  • FDA (also) regulates the labeling of products
    under its jurisdiction. This information, which
    must be rigorously truthful, well documented, and
    not misleading, plays a major role in protecting
    consumers and the public health. The
    FDA-regulated food label is helping shoppers eat
    a healthy diet the labeling of drugs and medical
    devices gives prescribers and patients reliable
    guidance about the safety and effectiveness of
    health care products.

14
Recent TV Ad (October 2001)
  • (several photos of couples, )
  • 3 bottles of male virility compounds!
  • Free three month supply, 3 bottles!
  • Simply pay 8.50 shipping and handling charges
    for each bottle!
  • No health claims are made for these pills in
    accordance with FDA regulations.

15
  • A medical device is"an instrument, apparatus,
    implement, machine, contrivance, implant, in
    vitro reagent, or other similar or related
    article, including a component part, or accessory
    which is
  • - recognized in the official National
    Formulary, or the United States Pharmacopoeia, or
    any supplement to them,
  • intended for use in the diagnosis of disease or
    other conditions, or in the cure, mitigation,
    treatment, or prevention of disease, in man or
    other animals, or
  • intended to affect the structure or any function
    of the body of man or other animals, and which
    does not achieve any of it's primary intended
    purposes through chemical action within or on the
    body of man or other animals and which is not
    dependent upon being metabolized for the
    achievement of any of its primary intended
    purposes."
  • FDA Definition

16
Is My Device a Medical Device?
  • http//www.fda.gov/MedicalDevices/DeviceRegulation
    andGuidance/default.htm

Contains overviews, marketing information, search
terms, etc.
17
Special Terms
  • 510k Premarket notification
  • Exemptions equivalent to pre 1976 devices or
    other approved devices
  • IDE investigational device exemption
  • PMAA premarket approval application
  • GLP good laboratory practices
  • GMP good manufacturing practices
  • Design Control
  • IRB Institutional review board

18
Device Classification Class I
  • Not life sustaining
  • No risk
  • No fixed standards
  • 510k (some) gt registration gt listing gt GMP
    (some) gt Record keeping
  • Tongue depressors, stethoscopes, screwdrivers,

19
Device Classification Class II
  • Not life sustaining, but must meet
    control/performance standards
  • 510k gt IDE gt PMAA gt Registration gt Record
    keeping
  • Sphygmanometer, powered wheelchairs, drapes,
    infusion pumps

20
Device Classification Class III
  • Life sustaining
  • 510k gt IDE gt data!!! gt PMAA gt Registration
    gt Record Keeping
  • Data techniques must include failure mode
    analysis, animal test, toxicology studies, human
    trials (IRB), PDP (product development protocol.)

21
FDA approval?
  • One or more years
  • Now you will be monitored

22
Registration
  • (All US (foreign optional)) (manufacturer or
    preparer or processor or propagator of device)
    must register yearly with FDA get a device
    registration . (30 days change)

23
Listing
  • All manufacturers must list w FDA all devices
    they market (q 6 mo.)
  • All manufacturers must supply FDA with all
    labeling advance copy of new labeling.

24
Registration Listing
  • traceability recallability
  • FDA may force recall, fines, reparations, repair,
  • FDA may inspect devices, records, labeling,
    documentation, licenses, laboratories, premises,
    etc at virtually any time.
  • FDA requires reporting of adverse events (MAUDE
    system.)

25
The 510k substantial equivalency process See
http//www.fda.gov/cdrh/devadvice/314.html
26
Related 510ks
  • Special minor modification of current device
  • Abbreviated guidance/control/consensus in place

27
Declaration of Conformance to a Recognized
Standard
  • ID of standards that were met
  • ID of any variations (alternate steps)
  • ID of any standards not applicable

28
Premarket Approval
  • Class 3, ensures adequate review
  • Fairly fixed format/content, includes standards,
    investigations, samples, all relevant data

29
Investigational Device Exemptions
  • Must have IRB approval(s) equitable risk
    selection, informed consent (documented),
    adequate safety controls, privacy/confidentiality
  • Investigator is RESPONSIBLE
  • No fixed format

30
Good Laboratory Practices
  • 1978 laws requiring GLP and laboratory audit and
    inspection procedures by the FDA
  • Must have records for audit, proof of
    maintenance, evaluation, inspection, etc.

31
Good Manufacturing Practices
  • FDA requirements regarding manufacturing of
    medical devices
  • Auditable records must be kept re
    input/output/QA/record keeping/standards/inspectio
    ns/etc
  • FDA may inspect/fine/etc.

32
Human Factors
  • Guidance document (1996) Do it by design. see
    http//www.fda.gov/cdrh/humfac/doit.html
  • General discussion/guidance re the design of
    medical devices
  • May become a required part of device
    documentation

33
Design Controls
  • See http//www.fda.gov/cdrh/comp/designgd.html
  • General guidance document regarding the
    application of design controls/methods that can
    properly address risk management, design
    development planning, interfaces, design cycles,
    etc.

34
Software
  • If part of a device, generally must meet same
    minimum standards as the device.
  • If standalone (say drug calculator) same general
    levels I no risk, II some, esp. if in
    radiation therapy machines, III life sustaining
  • 8-20 of all deaths are software related.
  • FDA has published guidelines, can inspect

35
FDA Inspections
  • Access to everything but sales/pricing/financial
    data
  • Close/fine/recall/etc. powers
  • Cooperate! Keep up to date on regulations! Have
    a good QA program

36
Drugs
  • FDA has even more say here.
  • All drugs must be tested on at least 2 properly
    chosen animal models (thalidomide). (Generally do
    test tube toxicity test first, then animals.)
  • Testing on humans must go through three or more
    stages under IRB control. Testing must stop if
    there is any untoward event.
  • Powers fine, recall, inspect, etc.

37
Animals?
  • Chimpanzees, cats, dogs, mice/rats, primates,
    rabbits, pigs, sheep, ferrets, woodchuck,
    armadillo, guinea pigs, lobsters, chinchillas,
    electric eels, opossums, angler fish, axolotl,
    slugs, pigeons, shark, zebra fish, tropical fish,
    trout, goldfish, C elegan, fruit fly, etc.

38
Drug testing in Humans
  • Under IRB approval (Informed consent)
  • Phase 1 small cohort, 20-80 people, look for
    major problems, safety, tolerance, dose limiting
    toxicities, mode of entry, dose range
  • Phase 2 100 - 300, look for dosing concerns,
    look for minor problems, efficacy, safety
  • Phase 3 1000-3000 develop and prove statistics
    on efficacy, safety, tolerance, possible other
    uses.

39
FDA Approval?
  • Screen 5000 compounds gt 5 trials gt 1 drug.
  • Blind/Double blind studies
  • High cost of development (360M), giving rise to
    mathematical modeling simulation
  • Penalties! 100M fine Abbott Labs Q/A.
  • .questions?
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