Transcript Food Drug and Cosmetic Act (Federal)

Pharmacy Law and Ethics
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Meet the Instructors
Overview of schedule
Blackboard – please use it!
Exams and Grading
Attendance
Respect for everybody’s opinions
Instructors
• Me (Joe Schnabel)
• Dell Alexander – R.Ph., J.D.
• Board of Pharmacy – members and
staff
• Karen Peterson – R.Ph., J.D.
• DEA Agents(?)
Course Overview
• Federal Laws (Joe Schnabel)
– FDA and DEA
• Civil/Criminal Law (Dell Alexander)
• State Law (Joe Schnabel)
• Ethics (Joe Schnabel)
Major Federal Drug Laws
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Food Drug and Cosmetic Act
Federal Alcohol Tax
Poison Prevention Packaging Act
OBRA 90
Controlled Substances Act
Sources of Federal Law
• Constitution
• U.S. Congress (House of
Representatives and Senate)
• Federal Agencies (FDA, DEA, CMS,
FTC…)
• Courts (Common Law)
Where to Find Federal Laws
• Federal Register
– Published daily
– On the internet
• Code of Federal Regulations (CFR)
– A compilation of Federal Law
– Updated more slowly than Federal
Register
Federal vs. State Law
• State can regulate where Federal doesn’t
• If there is a Federal regulation, State can
only make more restrictive
• State can not permit activities that are
illegal under Federal Law
• Conflicts? Feds win! Usually…
– See Oregon: Medical Marijuana, Death With
Dignity Acts
– “State’s rights” issues (See: Civil War)
Regulatory Agencies
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Oregon Board of Pharmacy
Drug Enforcement Administration (DEA)
Food and Drug Administration (FDA)
Oregon Public Health Services
Centers for Medicare and Medicaid Services
(CMS)
• Federal Trade Commission (FTC)
• Joint Commission on Accreditation of Healthcare
Organizations (JCAHO)
Pharmacy Laws
• Statutes (ORS) - from the Oregon
Leglslature
• Administrative Rules (OAR) - from
the Board of Pharmacy
• Federal Laws (CFR)
– From US Congress
– From FDA and DEA
Four Categories of Professional Activity
Legal
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Illegal
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You will have to make
You will want to spend
most of your time in this difficult decisions that
are in this box. Do what
box.
is best for the patient!
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Unethical
You might get away with
things in this box, but
you should avoid them!
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Stay away! People in
this box can and do lose
their licenses.
11 years old
14 years old
History of Food and Drug Law
• 1906 Pure Food and Drug Act
• 1938 Food, Drug, and Cosmetic Act
• 1951 Durham-Humphrey Amendment
• 1958 Food Additives Amendment
• 1960 Color Additives Amendment
• 1962 Kefauver-Harris Amendment
• 1976 Medical Device Amendments
History of Food and Drug Law
• 1983 Orphan Drug Act
• 1984 Drug Price Competition/Patent Term
Restoration Act
• 1987 Prescription Drug Marketing Act
• 1990 Nutrition Labeling and Education Act
• 1992 Prescription Drug User Fee Act
• 1994 Dietary Supplement Health and Education
Act
• 1997 Food and Drug Modernization Act
1906 Pure Food and Drug Act
• Inspired by widespread sales of ineffective
and/or unsafe “remedies”
• No provision to test drugs prior to sale
• Action taken only after harmful effects occurred
• 1906 law was preceded by 103 bills dating to 1848
• Opposition to 1906 law was overcome by Upton
Sinclair’s Novel “The Jungle”, which exposed
substandard (and disgusting!) meat packing
conditions (see Blackboard for excerpt)
1906 Pure Food and Drug Act
1. Protect public from adulterated and
misbranded food and drugs
2. States took limited action to solve problem
of interstate commerce
3. Secure a uniform law throughout the U.S.
The Food and Drug Administration, 1862
1906 Pure Food and Drug Act
• Needed Strengthening and six amendments
were added over the years
• Amendments were inadequate to monitor
growing technology
• Did not require premarket testing for
safety
• 1938 Elixir of Sulfanilamide Case
• prepared with diethylene glycol, a poison
1938 Food Drug and Cosmetic Act
• Is current law of the land, as amended.
• Gave the Federal Gvt power to establish
product safety, but did not mention efficacy
• Regulates Drug quality
• No new drug can be marketed until proven
safe under conditions described on the label
• required all drugs to be labeled with
“adequate directions for use”
1951 Durham-Humphrey Amendment
• Many drugs on market were not safe for use,
except under medical supervision
• These drugs could not meet “adequate directions
for use” requirement
• Drugs labeled by manuf. with “Caution: Federal law
prohibits dispensing without a prescription” are
exempt from labeling requirement directing
“adequate directions for use”
• Labels on Rx drugs do not contain directions on
how to use the product
1951 Durham-Humphrey Amendment
• Established the category of
“prescription” or “legend” drugs
• Established the OTC (nonprescription) category of drugs
Kefauver-Harris Amendment 1962
• Required proof of efficacy and strengthened
safety requirements
• Thalidomide tragedy occurred at this time
• Manufacturers had to evaluate pre-1962 drugs for
efficacy
• Led to DESI - Drug Efficacy Study implementation
• National Academy of Sciences reviewed 50,000 +
Rx/OTC Products
• Established Good Manufacturing Practices (GMP)
• Strengthened clinical trial safeguards/adverse
reaction reporting
Thalidomide
Medical Device Amendment 1976
• Gave FDA much more oversight of medical
devices
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Similar safety and efficacy issues
Classification of devices according to function
premarket approval required
establishment of performance standards
“Good Manufacturing Practices” (GMP) required
record keeping and reporting of problems
Orphan Drug Act 1983
• Orphan drug - drugs that have little or
no commercial value (rare diseases)
• Drug development costs exceed any
possible return on investment
• Provides pharmaceutical manufacturers
tax and licensing incentives to develop
them
Drug Price Competition and PatentTerm Restoration Act 1984
• Also called Waxman-Hatch Amendment
• Streamlined generic drug approval process
to make them more readily available
• Brand-name manufacturers have become
increasingly creative at delaying generics
• Bush limits automatic 30-month patent
extensions to one in 2002
Prescription Drug Marketing
Act of 1987
• Established sales restrictions and recordkeeping
requirements for prescription drug samples
• Prohibits hospitals and other non-profit
organizations from reselling Rx items to other
businesses
• Requires state licensing of drug wholesalers
“Drug” means:
(A) articles recognized in the official United States Pharmacopoeia,
official Homoeopathic Pharmacopoeia of the United States, or
official National Formulary, or any supplement to any of them; and
(B) articles intended for use in the diagnosis, cure, mitigation, treatment,
or prevention of disease in man or other animals; and
(C) articles (other than food) intended to affect the structure or any
function of the body of man or other animals; and
(D) articles intended for use as a component of any article specified in
clause (A), (B), or (C). A food or dietary supplement for which a claim,
subject to sections 403(r)(1)(B) and 403(r)(3) of this title or
sections 403(r)(1)(B) and 403(r)(5)(D) of this title, is made in
accordance with the requirements of section 403(r) of this title is
not a drug solely because the label or the labeling contains such a
claim. A food, dietary ingredient, or dietary supplement for which a
truthful and not misleading statement is made in accordance with
section 403(r)(6) of this title is not a drug under clause (C) solely
because the label or the labeling contains such a statement.
Definition of “Drug” in English
• It is listed in the United States Pharmacopoeia/
National Formulary (USP/NF), or the official
Homoeopathic Pharmacopoeia of the United
States, or any supplement to them.
• It is intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease.
• It is intended to affect the structure or any
function of the body.
• It is a component of any article specified above.
Drug Definition
• Established by FDCA
• Articles recognized as official by
USP, Homeopathic Pharmacopoeia, NF
• To treat disease
Counterfeit Drug
• A drug whose container or label bears
trademark, trade name or other
identifying mark, imprint or device,
likeness…
• Without legal authorization
• Recent increase in counterfeiting of
high cost drugs
Device
• instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other
similar or related article, including any component,
part, or accessory
• Intended to diagnose or treat diseases
• Similar wording to “drug” definition
Foods vs. Drugs
• Natural products--Health Foods
• i.e.., St. John’s Wort to treat
depression
• Sometimes called “Nutraceuticals” if
neither food or drug
• Often lacking evidence of efficacy
“Nutritional Supplement”
Regulation
• Nutrition Labeling and Education Act
of 1990
• Dietary Supplement & Health
Education Act of 1994
– both prohibit disease prevention claims
of dietary supplements
– regulates allowable claims
• nutrient deficiency, how it affects the body,
mech of action etc.
Labels and Labeling
• Label: Display of written material on the
product’s container and on the outside
container or wrapper, if any.
• Labeling: All labels and other written,
printed, or graphic matter on any container
or wrapper or material accompanying the
product (package insert, advertising)
Official Compendia
• United States Pharmacopoeia/
National Formulary (USP/NF)
• Homeopathic Pharmacopoeia of the
United States
Enforcement
• FDA can enforce FDCA via civil or
criminal charges
• FDA works with other agencies i.e....,
State Boards of Pharmacy, DEA,
Customs Service…
Product Recalls
• FDA can remove adulterated or
misbranded products from the
market via a recall
• Usually a manufacturer informs the
FDA of a problem and initiates a
voluntary recall
Product Recalls
• Recalls are divided into three classes I, II, III
– Class I
• reasonable probability that the use of or exposure to the
product will cause serious adverse consequences or death.
– Class II
• may cause temporary or medically reversible adverse
consequences or the probability of serious adverse health
consequences is remote.
– Class III
• not likely to cause adverse health consequences
Product Recalls
• 1994
– Two Class I Recalls
– 120 Class II Recalls
– 145 Class III Recalls
Source: FDA
Adulterated Drugs
• If it consists in whole or in part of any
filthy, putrid or decomposed substance
• If it has been prepared, packed or held
under unsanitary conditions whereby it may
have been contaminated with filth, or
whereby it may have been rendered
injurious to health
• If the strength differs, or quality or
purity fall below label standards
Adulterated Drugs
• Most provisions apply to manufacturers
• A pharmacy is considered a manufacturer
if it repackages or compounds for resale
Current Good Manufacturing
Practice (GMP)
• A drug is adulterated unless it is
manufactured in accordance with GMP
• GMP establishes minimum requirements for
facilities, manufacturing controls,
processing , packaging.
• Pharmacies are not subject to GMP unless
they are manufacturing Rx products for
resale to other pharmacies, physicians or
retail outlets
Product Tampering
• Congress passed the Federal AntiTampering Act 1982
• Gave authority to FBI, USDA and
FDA to investigate tampering
• Due to Tylenol capsule tampering
Misbranded Drugs (Definition)
• If the label is false or misleading
• Label must contain name/place of
business
• Accurate statement of contents
• If required information is not
displayed as required
• Label must warn of habit forming
drugs
Counterfeit Drugs
• Misbranding occurs if one drug is an
imitation of another drug
• Neupogen®, Epogen® in 2002
• Viagra®
• More likely with high cost drugs
• See Dangerous Doses, by Katherine
Eban
Batch Certification
• 1941 Amendment to FDCA mandated
insulin batch certification for
efficacy and safety
• 1945 Amendment to FDCA mandated
antibiotic batch certification for
efficacy and safety
• D/Cd in 1982