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86 Cards in this Set
- Front
- Back
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What are the official compendia for drugs?
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(1) USP = United States Pharmacopeia (2) NF = National Formulary (3) Homeopathic Pharmacopeia
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Who established the offical compedia for drugs?
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Private organizations; FDCA recognized them as legal source of drug standards
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What do the official compendia do?
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(1) Establish quality standards for drugs and related items (2) Establishes standards for storage and packaging of drugs
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What is Food?
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(1) Articles used for food or drink for man/animals (2) chewing gum (3) Articles used for components of [1]
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What is Drug?
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(1) Articles recognized by the official compendia for drugs (2) Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man/animals (3) Articles other than food intended to affect the structure/function of the body of man/animals (4) Articles used for components of [1,2,3]
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Give examples of Special dietary foods
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Infant formula, artificial sweetener
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Give examples of Medical foods
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Foods without phenylalanine for PKU
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Who allowed the FDA to approve certain health claims for foods based on guidelines and petitions from the supplier that supports the claim?
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(1) Nutritional Labeling and Educaiton Act (2) FDAMA
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What is considered a new drug?
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(1) new active ingredient (2) new drug combination (3) proportion of ingredients in drug combination changed (4) new intended use of drug (5) New dosage, form, or duration of administration (5) Pre-1938 drugs; New drug = one that is not generally recognized by qualified experts as safe and effective for use under the given conditions
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When is the IND submitted?
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IND = Investigational New Drug; Before Clinical Studies
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When is the NDA submitted?
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NDA = New Drug Appliation; After Clinical Studies
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What is the primary purpose of IND?
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Protection of human subjects
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What are the requirements for the IND?
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(1) Name of drug (2) Composition (3) Methods of manufacturing and quality control (4) Information from preclinical investigations regarding pharmacological, pharmacokinetic, and toxicological evaluations
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Can the FDA's decision regarding IND Applications be appealed?
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No, decisions are final
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What are the different stages in Clinical Studies?
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Phase 1 = determines adverse effects; Phase 2 = determine efficacy and dosage range; Phase 3 = Often randomized controlled trials versus placebo and/or drug already on market
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This law requires a large fee upon submitting an NDA
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Prescription Drug User Fee Act of 1992 (PDUFA)
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This law covers the expense of FDA reveiwers
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Prescription Drug User Fee Act of 1992 (PDUFA)
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This law encourages drug sponsors to apply only if they have a high probability of success
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Prescription Drug User Fee Act of 1992 (PDUFA)
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How much time does the FDA have to rule on submitted NDAs?
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180 days, but delays past that limit are normal
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This law allowed Patient treatment with investigational drugs (Treatment IND's)
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FDAMA
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What is Parallel Track Policy, and which law allows it?
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Individual patient access to investigational drugs for serious diseases; FDAMA
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This law allowed Fast Track Approval
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FDAMA; Expedited approval of drugs intended to treat life-threatending diseases
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Fast Track Approval is conditional upon _____
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Completion of postmarketing (Phase 4) clinical studies
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What is PTRA?
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Drug Price Competition and Patent Restoration Act of 1984 (Market Exclusivity; Waxman-Patch Amendment)
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How long are drug patents?
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20 years
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Which law created the ANDA?
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PTRA
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Which law allows the FDA to grant innovator drugs patent-term extensions?
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PTRA
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Which law provides for market exclusivity?
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PTRA
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For a new drug, PTRA prevents a generic drug application from being submitted for _____ from the date of approval of the drug
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5 years
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For an new indication for a previously approved drug, PTRA prevents a generic drug application from being submitted for _____ of exclusivity from the date of the new indication approval
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3 years
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What are the controversies regarding PTRA?
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(1) Patents made by innovator manufacturers to generic manufacturers to prevent or postpone the ANDA (2) Product hopping (when the brand manufacturer tactically reformulates the drug and re-patents the new formulation
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What are the uses of Supplemental NDA?
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(1) To change or update information regarding an already approved drug (2) Commonly used to add indications (3) Also used for the Rx-to-OTC switch
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What is the reference listed drug?
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aka innovator drug; an approved drug product to which new generic versions are compared to show that they are bioequivalent (ANDAs must refer to the Reference Listed Drug)
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What is a generic drug?
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The same as a brand name drug in dosage, safety, strength, administration, performance, and intended use; By law, a generic drug product MUST contain the identical amouns of the same active ingredients as the brand name product
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A generic equivalent may vary in rate and extent of absorption to +/-___% from the reference listed drug
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20
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Why are generics cheaper?
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Because the ANDA does not require the need for safety and effectiveness through clinical studies
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What needs to be proven in an ANDA?
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Bioequivalence to the innovator drug/RLD
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What are the four types of ANDA?
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Paragraph 1 - The NDA holder did not file information on the patent to the FDA; Paragraph 2 - The patent already expired; Paragrapjh 3 - The date that the patent will expire; Paragraph 4 - The patent is invalid or will not be infringed by the manufacture, use, or sale of the generic applican's drug
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What are the stipulations concerning Paragraph 4 of ANDA?
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(1) Applicant must notify the patent owner (2) If the patent owner sues, the FDA is prevented from approving the ANDA until either 30 months pass or the court rules on the issue (3) The first approved Paragraph 4 ANDA for a given drug awards the applicant 180 days of market exclusivity
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What does Authorized Generic mean?
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The manufacturer of an innovator drug may produce a generic verison of its drug without submitting an ANDA = gets 180-day market exclusivity for its own generic
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What are the ways to stich from Rx to OTC?
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(1) The manufacturer may request the switch by subbiting a supplemental NDA (2) The manufacturer or other entity may petition the FDA to add or amend an OTC monograph (3) The FDA may add or amend an OTC monograph through OTC drug review
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Describe when manufacturer submits OTC monograph vs NDA
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OTC Monograph (recipe book with acceptable ingredients, doses, formulations, and labeling) = Once in a monograph, ANY manufacturer can market the drug without an individual product license; NDA (with FDA approval) = Each drug product must first receive approval from the FDA to be sold OTC
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Compare/Contrast: NDA vs OTC Monograph: PREMARKETING APPROVAL
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NDA: Yes; OTC Monograph: No
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Compare/Contrast: NDA vs OTC Monograph: PRIVATE/PUBLIC
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NDA: Confidential filing; OTC Monograph: Public process
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Compare/Contrast: NDA vs OTC Monograph: USER Fee
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NDA: May require a user fee; OTC Monograph: NO user fees
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Compare/Contrast: NDA vs OTC Monograph: Marketing exclusivity
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NDA: Potential for marketing exclusivity; OTC Monograph: NO marketing exclusivity
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Compare/Contrast: NDA vs OTC Monograph: Mandated FDA review timelines
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NDA: Yes; OTC Monograph: No
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Compare/Contrast: NDA vs OTC Monograph: Clinical Studies
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NDA: MAY require clinical studies; OTC Monograph: MAY require clinical studies
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Describe the process of OTC Drug review
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(1) FDA appoints advisory panel of qualified experts to review drugs by class (2) FDA publishes recommendations in the Federal Register for public comment (3) FDA publishes proposed rule in the Federal Register (4) FDA publishes a monograph in the CFR
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What are the different categories in the monograph in the CFR for OTC drug review?
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Category 1 - Ingredients are safe/effective/not misbranded; Category 2 - Ingredients are NOT generally recognized as safe/effective/not misbranded; Category 3 - Ingredients for which data available are insufficient to permit classification
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What are the stipulations regarding post-marketing surveillance?
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Manufacturers MUST report any serious adverse drug reactions and any new information regarding a drug's safety and efficacy; Health care professionals and consumers CAN report serious problems they suspect
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What is REMS?
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Risk Evaluation and Mitigation Strategies; (1) Used for exceptionally high-risk drugs (2) FDA MAY require special procedures (3) Usually affect the dispensing of these medications (4) Manufacturer MUST submit periodic reports ot the FDA regarding how well the drug's risks are being managed
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What is a label?
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The display of written, printed, or graphic matter upon the immediate container/wrapper [See Lecture 3 Handout pg 43]
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What is labeling?
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The label PLUS any accompanying information such as the package insert, the patient package insert or other materials [See Lecture 3 Handout pg 43]
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What are labeling requirements for OTC Drug Products?
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(1) Statement of the identity of the product /pharmacological category/principal intended action (2) The name and address of the manufacturer/packager/distributor (3) The net quantity of the contents of the package (4) Cautions and warnings (5) Adequate directions for use (6) Drug Facts panel [See Lecture 3 Handout pg 44]; Lot # and expiration date are on the container, not the label
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What is the NDC?
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NDC = National Drug Code; Serves as a universal product identifier for human drugs
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Does the presence of an NDC number indicate that the drug has received FDA approval?
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NO
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What requires the 11-digit standard for NDC's?
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HIPAA regulations
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What requires manufacturers to put NDC to be put on labels?
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HIPAA regulations
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What are NDC numbers used for?
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(1) Process 3rd party prescription claims (2) Track distribution of products
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What requires the NDC to be in linear bar code formatting?
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FDA rules
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What is the Federal Anti-Tampering Act?
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Requires that certain OTC drugs, cosmetics, and devices be manufactured with tamper-resistant packaging
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Describe the NDC
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12345678900; 12345 = Manufacturer/Labeler; 6789 = Drug Product; 00 = Package Size
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According to the CGMP, how often are manufacturers inspected by the FDA?
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Every 2 years; Manufacturers are registered with the FDA
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Does CGMP apply to pharmacies?
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NO, unless the FDA determines that the pharmacy is manufacturing
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Does the FDA have statutory authority to mandate a recall?
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NO (Exception: biologicals, medical devices, infant formulas); NOT drugs
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What are the consequences if a manufacturer refuses to recall a drug?
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FDA may file a criminal suit = seizure of drug product/court-ordered recall
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What are the FDA classification of drug recalls?
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Class 1 = Drug product may cause serious, adverse health consequences inc death, recall should include stocks in pharmacies and notifications of patients to whom the drug has been dispensed; Class 2 = Drug product may cause temporary or reversble effects and teh probability of serious adverse health effects is remote, recall includes stock in pharmacies; Class 3 = Drug product is unlikely to cause any adverse health consequences
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What is the manufacturer's responsibilty in terms of drug recalls?
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To send written call notices to all wholesalers and pharmacies for recalls in Class 1, 2, and some Class 3
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What is the pharmacist's responsibility in terms of drug recalls?
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To be aware of all recalls, and if necessary, contact patients taking the recalled product
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What is market withdrawal?
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When a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation (i.e. a product removed from the market due to tampering, w/o evidence of manufacturing or distribution problems)
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Are pharmacies excempted from the misbranding, adulteration, and new drug provisions in the FDCA?
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YES; pharmacies are exempt from registering as manufacturers if they do not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail
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What regulates traditional compounding pharmacies?
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State law (Boards of Pharmacy)
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What is the adequate provision requirement regarding drug advertising?
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Allows advertisements on broadcast media to only present the major risks of the drug and make adequate provisions to obtain further information
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What protects drug advertising?
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First amendment of the US Constitution
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To permit government regulation of advertising (speech), what factors MUST be met?
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(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 government interest asserted (4) The restriction of speech cannot be more extensive than necessary to serve that interest
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What MUST all drug advertisements include?
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(1) Established name of the drug (2) The formula, showing quantitatively each ingredient (3) A brief summary of other information related to side effects, contraindications, and effectiveness
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All drug advertisements MUST NOT…
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(1) Be false or misleading (2) Bias effectiveness information over side effects and contraindications (3) Exclude material facts
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What are exceptions to regulations regarding drug advertisements?
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(1) Reminder advertisements (2) Substances for manufacturing or compounding
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Are industry-supported educational programs subject to FDA regulation?
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Only if the manufacturer has any control or influence over content
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What is the biggest downside of industry-supported educational programs?
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Off-label uses could not be discussed
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What is the rule regarding industry gifting?
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Manufacturers SHOULD NOT give out items that do not advance education (i.e. pens, note pads, mugs, stethoscopes, etc)
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Can manufacturers tell physicians/prescribers information about off-label uses of a drug?
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Only if the physicians/prescribers ask
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What are the rules regarding publications of off-label uses of drugs?
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(1) Unabridged peer-reviewed articles (2) Not influenced by the company (3) Well-controlled clinical investigations considered by experts as scientifically sound (4) Separated from promotional materials (5) Disclosure that the use has not been approved by the FDA (6) Disclosure of any relationship between the company and the author of the article (7) Bibliography and other information, inc contrary conclusions
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What are the types of DTC ads?
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DTC = Direct to Consumer; (1) Product claim ads = name the drug and the conditions it is approved to treat; subject to FDA regulations (2) Reminder ads = name the drug but not its uses; not subject to FDA regulations; (3) Help-seeking ads = educational, mention the name of the company but not the drug; not subject to FDA regulations
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When can the FDA require a change in a DTC advertisement?
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If the issue is related to seious health risks associated with the drug's use
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