Defining and Distinguishing Drugs from Foods, Devices, and Cosmetics
hardware store sells DMSO to Mary. Mary intends to apply it externally to reduce joint pain because she read it online. Neither the hardware store nor the manufacturer made these therapeutic claims. Would the courts consider DMSO a drug?
not a drug because the intended use is industrial paint thinner
in the FDA classification system, what is the therapeutic designation for letter S
S = standard
In the FDA classification system, what does the number indicate
number indicates the drug's chemical type
when can the FDA remove a dietary supplement from the market?
only when the FDA can prove the product is adulterated
What is "advertising"
package drug insert or label sent out, not accompanying the drug
under the FDCA which is considered an official compendia: a) Unites States Pharmacopoeia-National Formulary (USP-NF) b) Homeopathic Pharmacopoeia of the United States (HPUS)
both! USP-NF - establishes drug standards (USP contains monograph of active ingredients NF contains monograph of inactive ingredients) HPUS - establishes homeopathic products standards
New Drug Application (NDA)
contains a complete evaluation of the drug's safety and efficacy; FDA has 180 days to act on a NDA; if disapproved, the FDA will notify the applicant and provide an opportunity for a hearing
FDA Rating and Classification System
determines how rapidly the drug will proceed through the NDA process; Priority vs Standard
what are the exceptions to the "true statement" requirement
does not apply to reminder ads, institutional ads
what is important about a drug that is designated FDA classification system, therapeutic designation letter S
drug has therapeutic properties similar to those of drugs already on the market and offers at best only minor improvements
what is important about a drug that is designated FDA classification system, therapeutic designation letter O
drug is a product that treats a rare disease affecting fewer than 200K Americans
what does the first segment of the NDC code identify?
first series = manufacturer or distributor
what is a class 2 devices
general controls alone are insufficient to ensure safety and efficacy; must meet specific performance standards ex. insulin syringes, infusion pumps, thermometers, tampons electric hearing pads
What are biosimilars
generic biologics
Blackbox Warning
highlights side effects or other important things the provider should know about the products
What is an "Imitation Drugs"
identical in shape, size and color; similar or virtually identical in gross appearance; similar in effect to controlled substance
when is a cosmetic considered misbranded?
if its label is false, misleads the consumer, or lacks the required info or if the label info is not clear enough to be read and understood by an ordinary consumeru
what is a class 3 devices
must have premarket approval because they are life-supporting or life-sustaining or they present a potential unreasonable risk of illness or injury ex. pacemakers, soft contact lenses, replacement heart valves
New Drug Approval
no new drug can be legally marketed in interstate commerce, unless the FDA has approved that product
does the FDA allow promotion of an approved drug product for an off-label use
no, this is considered misbranding
Phase 4 Studies
post-marketing study
how does regulation of cosmetics *differ* from that of drugs and devices
premarket approval from FDA is not necessary for a cosmetic (except for color additives)
What are "Adulterated Drugs"?
prepared, packaged, or held in condition where it may have been contaminated; exposed to a contaminated that may have been contaminated; *OR* manufactured under conditions that do not conform to cGMP
how is the regulation of cosmetics *similar* to that of drugs and devices
they are subject to certain misbranding and adulteration laws adn the FDA can take action against them
what does the third segment of the NDC code identify?
third series = package size and type of drug
True or False the FDA will *NOT* regulate industry-supported programs that are independent and nonpromotional
true
in the FDA classification system, what is the chemical designation type 1
type 1 = new molecular entity
in the FDA classification system, what is the chemical designation type 10
type 10 = new indication submitted as distinct NDA, not consolidated
in the FDA classification system, what is the chemical designation type 2
type 2 = new active ingredient
in the FDA classification system, what is the chemical designation type 3
type 3 = new dosage form
in the FDA classification system, what is the chemical designation type 4
type 4 = new combination of compounds
in the FDA classification system, what is the chemical designation type 5
type 5 = new formulation or new manufacturer
in the FDA classification system, what is the chemical designation type 6
type 6 = new indication (drug product previously marketed by the same firm)
in the FDA classification system, what is the chemical designation type 7
type 7 = drug already marketed without an approved NDA
in the FDA classification system, what is the chemical designation type 8
type 8 = OTC switch
in the FDA classification system, what is the chemical designation type 9
type 9 = new indication submitted as distinct NDA, consolidated with original NDA after approval
what is a "dietary supplement"?
under DSHEA tit is a product intended for ingestion and is intended to supplement the diet
Medwatch
voluntary medication adverse reaction reporting form ( form FDA 3500)
what is Pregnancy Warning Category A
Category A - adequate and safe studies in pregnant females haven't shown risk to fetus
what is Pregnancy Warning Category B
Category B - most drugs; animal studies fail to show risk in animals - no adequate tests in humans
what is Pregnancy Warning Category C
Category C - no animal studies or animal stuied show adverse reactions to fetus; no human testing
what is Pregnancy Warning Category D
Category D - studies proven fetal risk, but potential benefits from dug may outweigh risks
what is Pregnancy Warning Category X
Category X - dangerous; require risk mitigation plan; ex. Accutane and Thalidamide
what is the supplemental new drug application
after approval of an NDA the manufacturer may not make any changes in the drug or its production
What is a 'Food"?
articles used for food or drink for man or other animals; chewing gum; *AND* articles used for components of any such article
are mobile applications that monitor heart rate during exercise or that record energy expenditure during workouts considered medical devices?
*NO!* FDA will not regulate a product as a medical device if it is intended for general wellness, is of low risk and makes no references to disease or medical conditions
What are the two major offenses under the FDCA?
1) Adulteration 2) Misbranding ~ violations are STRICT LIABILITY in nature -> NO EXCUSE!
three procedural categories of the supplemental new drug application
1) production - synthesis of a drug; prior FDA approval required 2) labeling changes - strength warningsor dosage and administration info; allows implementation of change before FDA approval 3) minor changes - editorial changes in the labeling or change in container size; no FDA approval required
what are the four criteria of the Central Hudson case?
1. the speech must not be misleading or related to an unlawful activity 2. the government interest in the regulation must be substantial 3. the regulation must directly advance the gov't interest asserted 4. the restriction of speech cannot be more extensive than necessary to serve that interest
three classes of product recall
Class 1: most serious; cause serious or adverse health consequences or death Class 2: cause temporary or reversible health consequences Class 3: do not cause serious or adverse health consequences or death
nonprescription drug advertising is regulated by___________ and prohibits _________?
Federal Trade Commission (FTC) unfair or deceptive acts or practices
in the FDA classification system, what is the therapeutic designation for letter O
O = orphan drug
what is professional OTC labeling
OTC labeling for certain indications intended specifically for the healthcare professional and not the consumer
in the FDA classification system, what is the therapeutic designation for letter P
P = priority
True or False? a drug is adulterated, even id pure, if subject to conditions that "MAY" contaminate it
TRUE
True or False? a drug is adulterated if its strength, quality or purity differ from the compendia standards
TRUE unless stated otherwise on the label
first FDA approved biosimilar
Zarxio in March 2015
What are "Combination Products"?
a combination of both a drug and a device; a combination of a few different things. regulated under its primary mechanism of action ex: epi-pen - drug plus device - regulated as a drug
Manufacturer claims that alfalfa tablets will cure ulcers and other GI disorders. The label specifically notes that the tablets are not drugs. Would the court consider the tablet to be a drug?
a drug because they are making a therapeutic claim
What is a counterfeit drug?
a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug maufacturor, processor, packer, or distributer other than the person or persons who in fact manufacture, process, pack or distribute such drug
National Drug Code (NDC) Number
a unique set of numbers for every drug
what is the Lanham Trademark Act
an act that prohibits the use of false description or representation, including words or symbols, in connection with the sale of any goods or services. It allows for private cause of action and the recovery of monetary damages and injuctive relief
Approved Drugs as New Drugs
an approved drug may become a new drug if: contains a new substance; there is a new combination of approved drugs; the proportion of ingredients in combination has changed; there is a new intended use; the dosage, method, or duration of administration or application has changed
What is a "Device"
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related articles, including any component, part or accessory, which is: recognized by the NF or USP; intended for use in diagnosis of disease or other conditions, or in the sure, mitigation, treatment, or prevention of disease in man or other animals; *OR* intended to affect the structure of any function of the body of man or other animals (not through chemical processes or being metabolized by the body)
what are "Cosmetics"?
articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applies on human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance of; *AND* articles intended for use as a component of any such article except that such term shall NOT include SOAP
what is a category 3 OTC drug
ingredients for which available data are insufficient to permit classification
what is a category 1 OTC drug
ingredients generally recognized as safe, effective, and not misbranded
what is a category 2 OTC drug
ingredients that are not generally recognized as safe and effective or misbranded
Pregnancy Warning
labeling regulations requiring the package insert to contain information about the risks of use during pregnancy Category A Category B Category C Category D Category X
Phase Zero Studies
large molecular weight products, being introduced for the first time in human studies, are given the dose separately and days apart in healthy human volunteers
how do recalls work?
manufacturer notifies the wholesaler; the wholesaler notifies the pharmacy; the pharmacy notifies the pt's
What are biologics (biologicals)
products derived from living organisms, and include viruses, therapeutic serums, toxins, antitoxins, vaccines, blood and components, and derivatives applicable to prevention, treatment, or cure of a disease or condition in humans
What is "Misbranding"?
putting something false on the label; regeneration and reissuing a Rx without MD approval
OTC Drug Review
regulated by the category of the drug Category 1 Category 2 Category 3
how are biologics/biosimilars regulated
regulation by both PHSA and FDCA premarket approval by the FDA and are subject to FDCA requirments licensed under PHSA
informed consent
requires investigator to obtain the subjects informed consent; inform them on the risks, benefits and alternative treatment options
what is a class 1 device
requires the least regulation because they pose the least potential harm to users; general controls are adequate to ensure safety and efficacy ex. needles, scissors, examination gloves, stethoscopes, toothbrush
what does the second segment of the NDC code identify?
second series = strength, dosage form and formulation
what is the "true statement" requirment
section 502(n) of the FSCA requiring: ~ the established name of the drug ~ the formula, showing quantitatively each ingredient ~ a "brief summary" of other information relating to side effects, contraindications, and effectiveness
Current Good Manufacturing Practice (cGMP)
set of regulations that establishes the minimum requirements for the methods, facilities, or controls used to manufacture, processing, packaging, or holding of a drug
FDA Approval Process
takes time (10+ years) and money ($billions)
advertising and promotion is subject to constraint under _______ and must meet the ________?
the 1st Amendment to the US Constitution four criteria of the Central Hudson case
how are medical devices categorized
the FDA must classify medical devices marketed after 1976 into one of three classes
what is the official compendia?
the United States Pharmocopoiea (USP) and the Homeopathic Pharmacopoiea of the United States (HP)
what is "Product Tampering"?
the act of improper interference with the product for the purpose of making objectionable or unauthorized changes
what is biosimilarity
the biological product is highly similar to the reference product with no clinically meaningful differences
what is important about a drug that is designated FDA classification system, therapeutic designation letter P
the drug represents a therapeutic advance because: ~ no other effective drugs are available ~ it is more effective or safe than drugs currently used ~ it has important advantages, such as greater convenience, reduced side effects, or impaired tolerance or usefulness in special populations
what is the intent of the FDA's "Bad Ad Program"?
the enlist healthcare professionals to monitor and report on misleading promotional drug manufacturer activities
Misbranding
the label shall not be false or misleading; provide established names of drugs, listing of any active ingredient for both Rx and OTC drugs; provide adequate directions for use, directions under which a layperson can use a drug safely and for the purposes for which it is intended; provide adequate information for use; not be an imitation drug
in the FDA classification system, what does the letter indicate
the letter indicates it's therapeutic potential
what happens when the FDA deems a device presents an unreasonable risk of substantial harm
the manufacturer must: 1) notify all health care professionals 2) recall the product if all that is insufficien, then: 1) repair the device 2) replace the device 3) refund the purchase price of the device
when does the FDA require black box warning
then the use of a drug may lead to death or serious injury
when has a manufacturer not met the "true statement" requirment
when the advertising: ~ is false of misleading ~ does not present a "fair balance" between side effects and contraindications information and effectiveness information ~ fails to reveal material facts
is a mobile application that connects to home-use diagnostic devices to collect data or to receive and transmit measurements considered a medical device?
yes it is regulated as a medical device
Adequate Directions for Use
~ Durham-Humphrey Amendment allows the MD directions to suffice and meet the requirement for pharmacies ~ manufacturer must include drug indication; side effects; dosages; routs=es, methods, frequency, and duration of administration; contraindiction; and other warnings
Federal Anti-Tampering Act
~ Federal offense to tamper with consumer products ~ requires certain OTC drugs, cosmetics, and devises be manufactured with tamper resistant packaging ~ violation may result in misbranding, adulteration, or both
what is considered a dietary supplement
~ a vitamin ~ a mineral ~ an herb or other botanical ~ an amino acid ~ a dietary substance for use by humans to supplement the diet by increasing the total dietary intake ~ a concrete, metabolite, constituent, extract, or combination of the previous
What is "Labeling"
~ includes all labels and any other written, printed or graphic matter upon any article, or on its containers, or accompanying such articles ~ Label and Package Drug Insert
What is a 'Drug"?
~ intended use: therapeutic claims vs structure/function claims ~any articles recognized in the USP, NF, HP; 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 of any function of the body of man or other animals; *AND* articles intended for use as a components of any articles specified above
when is a cosmetic considered adulterated?
~ it contains any poisonous or deleterious substance that may injure users ~ it contains any filthy, putrid, or decayed substance ~ it was prepared under unsanitary conditions ~ the container contains a substance that may contaminate the contents ~ it contains an unsafe color additive but is not a hair dye
What is a "Label"
~ label approved by the FDA and stuck on the stock bottle ~ display of written, printed, or graphic matter upon the immediate container of any article
Phase 3 Clinical Trial
~ large number of subjects & multi-center studies ~ double-blind (masked) and placebo controlled
Phase 1 Clinical Study
~ smaller number of subjects ~ investigators examine the drug toxicity, metabolism, bio-availability, elimination, and other pharmacological actions ~ purpose is to detect adverse effects, not efficacy! ~ conducted on healthy human volunteers (except cancer)
Phase 2 Clinical Studies
~limited number of subjects ~ purpose is to determine the efficacy of the drug and the dosage at which efficacy occurs ~ every phase tests safety ~ tested on subjects with the disease
