Law exam 1 Flashcards
Branches of government
legislative: makes the laws
Judicial: interprets the law
Executive: enforces the law
Checks and Balances
Makes sure that all three of the branches have equal power so not one is more powerful than the other
market failures
Public goods: manufacturers will not produce what they will not get incentives for such as orphan drugs and vaccines
Externalities: one issue affecting one party more than another example antibiotic resistance
Natural monopolies: one group of manufacturers might have a tendency to produce more of the drugs thus they will get more money
Information asymmetry: information not being known in full amount by a certain group than another
Public goods:
manufacturers will not produce what they will not get incentives for such as orphan drugs and vaccines
Externalities
one issue affecting one party more than another example antibiotic resistance
Natural monopolies
one group of manufacturers might have a tendency to produce more of the drugs thus they will get more money
Information asymmetry
information not being known in full amount by a certain group than another
doctors know more than patients
Why regulate drugs
Market failures
Best interest of patient
Highly regulated profession
Limits on the law
Minor violations
Sources of Law
Federal vs State
- Federal law over state law
- There is a discrepancy when the state is less strict
Constitution
3 branches
What does each branch do
Administrative agencies
- Examples: statutory,
Criminal vs Civil vs Administrative
civil: private vs private
Criminal: federal vs private
Administrative: agency vs private
Code of Federal Regulations
compilation of final regulations divided and indexed by subject matter
Federal Register
daily publication of proposed and final regulations and notices
State
Branches
Agencies
idk rn
State vs. Federal
What to follow- federal over state if ever an option
Court cases/Trial Procedure
Plaintiff tries to state their point and warrant that the defendant’s point has not merit
Notwithstanding can allow the judge to override the verdict if the jury came to the wrong one
A witness can face penalty if they do not show up in court
Defendant can issue a plea of bargain so that they not be arrested
FDCA
1- A drug has to be proven safe and effective for use before it is marketed and sold
2- has to be proven by the Food and Drug Administration (FDA)
3- forms the nucleus for today’s laws
Durham Humphrey
Rx & OTC
Oral prescriptions
1- Labels must have directions for use and warnings about the habit-forming properties of drugs.
2- This applies to cosmetics and devices as well.
3- Drugs on the market at this time were not safe for use except under medical supervision.
1- Established two classes of drugs
prescription and over-the-counter
2- Labels of prescription drugs do not need to contain “adequate directions for use” as long as they have “Caution: Federal law prohibits dispensing without a prescription”
1- The label for “adequate directions of use” is satisfied by a pharmacist putting the label of directions from the prescriber
2- Authorizes oral prescriptions (giving prescriptions by word of mouth) and refills of prescription drugs
Food Additive
requires the Food and Drug Administration (FDA) to ban food additives that are found to cause or induce cancer in humans or animals as indicated by testing.
Color Additive
- cannot be used to hide impurities of food
1- Requires manufacturers to establish the safety of color additives in foods, drugs, and cosmetics.
2- The FDA can approve a color for one use but not the others (e.g. external use only)
Kefauver Harris
Established that drugs need to be not only safe but effective and need to be tested in pregnancy subjects too
Established pregnancy warnings
1- required drugs to be proven not only safe but also effective.
2- Place control of prescription drug advertising from the Federal Trade Commission to the FDA
established
3- Good Manufacturing Practices (GMP)
added more extensive controls for clinical investigations, informed consent, and reporting of adverse drug reactions
Medical Device
- made sure that they were effective to implement chemical and biological effect for medical benefit
1-The FDA could not review medical devices for safety and efficacy before marketing
2- Congress amended the FDCA to provide more extensive regulation and administrative authority regarding the safety and efficacy of medical devices.
1- Classification of devices according to their function
2- premarket approval
3- Establishment of performance standards
4- Conformance with GMP regulations
5- Adherence to record and reporting requirements
Orphan Drug Act
- created incentives for manufacturers to create orphan drugs for rare diseases
1- Pharm. companies told Congress that the NDA process was too expensive to make drugs for diseases that affected a few people.
2- Congress provides tax and exclusive licensing incentives for companies to develop and market these drugs– so this is the Orphan Drug Act :)
what is an orphan drug?
drugs for “rare diseases or conditions” (defined as those affecting fewer than 200,000 Americans.)
PDMA - prescription drug marketing act
1- Prescription drug samples will have sales restrictions and record-keeping requirements
2- Prohibits hospitals and other healthcare entities from reselling their drugs
3- Other businesses require state licensing of drug wholesalers.
4- A secondary distribution system for prescription drugs was threatening public health and safety and creating an unfair form of competition.
Safe Medical Device Act
- makes sure that medical devices are safe
1- Made the FDA have additional authority for post-marketing requirements and premarket notification
2- also allowed for approval while speeding up the premarket device approval process.
Generic Drug Enforcement Act
- made it so that generic drugs are used instead of brands because they are cheaper
1- Occurred when some FDA staff accepted bribes from generic drug industry workers to facilitate the approval process of certain generic drug products.
2- The FDA banned individuals or firms from participating in the drug approval process if convicted of related felonies.
3- Impose severe civil penalties for any false statements, bribes, failures to disclose material facts and other related offenses.
PDUFA - prescription drug user fee act
- allowed the FDA to collect user fees from an ultimate user of drugs
1- The FDA and Congress took the approach that private industry should handle part of the costs for new drug approval rather than the taxpayers.
2- Requires manufacturers to pay fees for applications and supplements when the FDA must review clinical studies.
3- Fees provide the FDA with the resources to hire more reviewers to assess these clinical studies and hopefully speed up the NDA review.
Food Drug Administration Modernization Act
- expedited important drugs such cancer, reproductive etc
1- Due to FDA criticism, the FDA was not efficiently administrating its statutory responsibilities, and the FDCA was too burdensome a regulatory system for drug approval.
2- FDAMA passed to streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices.
1- The intent is to eliminate backlogs in the approval process and ensure timely review of applications.
2- Creates fast fast-track approval process for drugs intended for serious or life-threatening diseases
3- Establish a database of information on clinical trials, authorize scientific panels to review clinical investigations, and expand the rights of manufacturers to disseminate unlabeled use information.
4- Expands the FDA’s authority over OTC drugs and establishes ingredient labeling requirements for inactive ingredients.
Drug Quality and Security Act
- drugs are now under surveillance to make sure that they are not being abused or harmful in any way
1- clarifies and strengthens FDA oversight over pharmacies engaged in the large-scale compounding and shipping of sterile products to other licensed entities.
2- The law also removed uncertainty regarding when a product compounded by a pharmacy is exempt from CGMP, labeling, and the new drug approval process.
3- title 1 also called the Compounding Quality Act
1- adds “track and trace” requirements for all entities in the chain of distribution of pharmaceutical products.
2- Requires manufacturers to provide transaction information to purchasers, who in turn must provide transaction information to subsequent purchasers.
3- The law also mandates an electronic, exchangeable product tracing system by 2023, strengthens wholesaler and third-party logistics licensure requirements, and requires manufacturers to serialize drugs by 2017.
4- Title II known as the Drug Supply Chain Security Act,
Food and Drug Administration Amendment Act
- safe and effective drugs
1- FDA’s broader use of the fees generated from PDUFA, substantially increased fees
2- In response to postmarket problems with certain drug products (i.e. Vioxx), the law provides the FDA with increased responsibilities and authority to regulate drug safety, label changes related to safety, clinical trial data reporting, and registries, requiring postmarket clinical studies to assess risk
3- requires companies to implement risk evaluation and mitigation strategies (REMS).
FDA Safety and Innovation Act
1- enables the FDA to inspect foreign drug manufacturers more regularly and requires the agency to target problematic manufacturing sites.
ACA
allowed every one to have affordable insurance
Created insurance option for poor, elderly and less for fortunate people
Drug
article recognized in compendia
Article the mitigates, treats and prevents disease
FDA
food drug administration
All drug approvals go through them
Device
- excludes articles that elicit their effect through chemical and or biological effect
Cosmetic
alters appearance, for cleansing
Food
any nutritious substance that people or animals eat or drink or that plants absorb in order to maintain life and growth.
Combination Product
therapeutic and diagnostic products that combine drugs, devices, and/or biological products.
Food Vs Drug vs supplement
- DSs are used to replace food and can be vitamins, amino acids, minerals, herbs etc
Label & labeling
The term labeling includes labels.
Labeling is defined as written or printed or graphic matter “accompanying” the article.
Courts have defined accompanying.
If the written, printed, or graphic matter is not labeled, it is advertising.
Official Compendia
USP
- Published by the USPC
- Sets uniform standards
- USPC works closely with the FDA but is private.
HPUS
- Publishes standards for homeopathy products by the HPCUS, a private organization
- Role and legal authority of HPUS
Pursuant to FDCA, if a drug is recognized in USP or HPUS, the drug product must meet all standards of the compendia.
Violations of FDCA
Adulteration
Misbranded
Violation of FDCA is subject to strict liability
- Good faith excuse applicable
Most prohibited acts involve misbranding or adulteration.
Adulteration
Adulteration provisions focus on both the facility and the product. A pure drug may be considered adulterated based on the facility.
A drug is adulterated if its strength, quality, or purity differs from compendia standards unless plainly stated on the label.
A drug is adulterated if its strength, quality, or purity differs from the label.
A product is adulterated unless manufacturer complies to CGMP.
CGMP is an exhaustive set of standards directed at manufacturers.
The failure to manufacture a product in a tamper-resistant container when required by law is adulteration and also misbranding.
Pill falls on the floor
Misbranded
Labeling must not be false or misleading, including healthcare economic information.
Labeling must include a listing of active ingredients and quantity and a listing of inactive ingredients in alpha order.
Labeling must contain “adequate directions for use” and “adequate warnings against use” by children and others for whom use might be dangerous.
If a drug cannot be labeled with “adequate directions for use,” it must contain “adequate information for use.”
It is misbranding if a drug imitates another drug.
The package promises hair growth and does not do that at all
Impact of adulteration and misbranding on pharmacy
- impacts the trustworthiness of pharmacy to hold to its word and deliver what it says that it would
Recalls
1- drug poses lethal effect
2- the drug has ADR
3- drug labeling violation
The FDAAA established the FDA authority to order drug recalls for certain products, but not drugs.
Three classes of recalls
Manufacturers are responsible for notifying sellers; sellers are responsible for notifying consumers, if necessary
Pharmacists responsible for knowing of product recalls
Product Tampering
Is illegal
Must be evident by the packaging and manufacture must provide product tamper evident packaging to ensure that the product is not tampered before getting to ultimate user
Label
Commercial Container label 77
Unit Dose Label 77
?
Package insert
Black Box Warning
Pregnancy Warning
?
Black Box Warning
- highest level of warning that can be given
Required in labeling when use of a drug may lead to death or serious injury
Required for many prescription drugs
Pregnancy Warning
- placed with package to warn against drugs affecting pregnancy, lactation, reproduction, etc
The labeling system prior to June 30, 2015, required that drugs potentially risky during pregnancy be placed into one of five categories: A, B, C, D, and X.
A- no harm
X- harm
A 2014 regulation replaces the above system.
For drugs approved after June 30, 2015, labeling will require the inclusion of three subsections to describe risks: “Pregnancy,” “Lactation,” and “Females and Males of Reproductive Potential.”
Drugs approved prior to June 30, 2015, will be gradually phased into the new labeling standards.
NDC
National Drug Code Number
Manufacture, product, package
10-digit three segment code (4-4-2, 5-3-2, or 5-4-1)
The first segment identifies the manufacturer or distributor;
the second identifies strength, dosage for, and formulation;
the third identifies package size and type of drug.
Billings and claims submissions require an 11-digit NDC number.
New Drug Approval
formulation/ early formulation: extracting the molecule or chemically creating it
Preclinical trials: testing the molecule in rodents
Apply for the IND to test it in humans
phase I: test the safety
Phase II: test the efficacy
Phase III: test the safety and efficacy
New Drug Application (NDA) Process
IND Investigational New Drug Application
The sponsor must receive an approved Notice of Claimed Investigational Exemption for a New Drug to ship the drug in interstate commerce to conduct phase 1, 2, and 3 clinical studies.
The FDA may terminate testing at any time under risk–benefit criteria; the decision is not subject to an appeal or judicial review.
The FDAAA requires NDA sponsors to publish summary information regarding phase 1 trials on a public registry.
The FDA has 180 days to act on a completed NDA, but delays are common.
Approval is based on proof of safety and efficacy, the manufacturing process, and risk–benefit ratio.
The applicant may judicially appeal a rejected NDA, but success is very unlikely.
Definition of New Drug
one that has not been previously recognized in the pharmacopeia
Has new substance
is defined as a drug that is not generally recognized by qualified experts as safe and effective (GRASE) for use under the conditions recommended in the drug’s labeling and has been used for a material extent and time for conditions recommended in labeling.
Approved Drug as a new drug
- when it passes all the clinical trials and is approved by the FDA
An approved drug can become a new drug under certain conditions:
- Addition of new substance
- New combination of approved drugs
- Change in proportion of ingredients
- New intended use
- Dosage, method, or duration of administration or application is changed
Informed consent for New drug approval
- should be received from the subjects of the study
Informed consent is required in all three phases of the clinical trial
Research subjects are required to know the risks, possible benefits, and alternative courses of treatment
Institutional Review Board (IRB) approval required in some settings
NDA- new drug application
- is applied for after all of the trials to be approved by the FDA as a new drug
The FDA has 180 days to act on a completed NDA, but delays are common.
Approval is based on proof of safety and efficacy, the manufacturing process, and risk–benefit ratio.
Applicant may judicially appeal a rejected NDA, but success is very unlikely.
FDA Rating and Classification
- rating drugs based off of therapeutic ability and not just by name
A priority classification system rates new drugs by chemical type and therapeutic potential; this determines how quickly the drug will move through the IND/NDA process.
A number designates chemical type, and a letter (S, P, or O) designates therapeutic potential.
Phases in Clinical Trial
I: Safety
II: efficacy
III: safety and efficacy
Risk Evaluation and Mitigation Strategy (REMS)
The FDAAA granted the 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, the FDA can require a variety of procedures ranging from Medication Guides to limiting the drug to specified settings for dispensing.
Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act)
- generics were created to compete with the production of brands
Statutorily created the ANDA, expediting generic approval
Concessions to innovator drug companies included:
- Patent extensions
- Market exclusivity
OTC Review
- Reviewing OTC for acceptable use by the public
The OTC drug review process approves drugs on the basis of therapeutic category and conformance to a monograph rather than on a drug-by-drug basis like prescription drugs.
