MPJE Study Guide Law Final Exam
Administrative agencies - Where do they come from? - Where do they get off? - Why have them?
"Creatures of statute" - created by legislation; gives statutory authority (confers and limits administrative scope of authority) - Sort of tyrannical: create law (rulemaking), enforce law (board comes after violations), and interpret law (board hearings; becomes de-facto law) → no separation of powers! - Necessary: legislature doesn't have expert opinion about specialized, technical fields (like pharmacy), so they need topic experts to make framework; to translate broad statute into specific, actionable regulations
why have administrative agencies?
, experts who understands the field will come in and translate the braod statutory commands into specific rules that can be applied on a day-to-day bases
why does the court needs to follow stare decisis?
- Benefits: consistency, efficiency (may resolve outside of court if expected outcome known based on precedent); helps one understand base expectations *less binding than statutes
What sorts of "experts" are appointed to administrative agencies? Are they typically "legal" experts?
- No, they are n ot legal experts typically they are experts in a specific field
Examples of information asymmetry in pharmacy (how are these addressed?)
- Patient knows much less about Rx AE than pharmacist (law requires counseling about certain AE) - Manufacturer knows everything about their drug (need complete labeling; prescriber info, patient education, MedGuides)
What prompted the creation of: - Pure Food and Drug Act 1906 - Food, Drug, Cosmetic Act 1938 - Durham-Humphreys Amendments 1951 - Kefauver-Harris Amendment 1962
- Pure Food and Drug Act 1906: "The Jungle" (expose of meat-packing industry in Chicago) exposed unsanitary manufacturing conditions - Food, Drug, Cosmetic Act 1938: sulfanalamine disaster (antifreeze poisoning) - Durham-Humphreys Amendments 1951: Humphrey as pharmacy assistant was worried about misbranding bc some OTC items weren't labeled for layperson - Kefauver-Harris Amendment 1962: thalidomide phocomelia birth defects; almost approved in US *previous act/amendments usually could've dealt with each of these, but they did bring up issues, so used as an excuse
Statutes - Pure Food and Drug Act 1906 - Food, Drug, Cosmetic Act 1938 - Durham-Humphreys Amendments 1951 - Kefauver-Harris Amendment 1962
- Pure Food and Drug Act 1906: prohibits knowingly adulterated (could claim ignorance), misbranded drugs; very ineffective + reactive (dangerous drugs allowed on market; no pre-market approval; gov't had to prove adulteration; ex: could have marketed unlabeled cyanide...) - Food, Drug, Cosmetic Act 1938: backbone of federal Rx regulation; proactive - required pre-market approval for safety (not efficacy) - Durham-Humphreys Amendments 1951: creates OTC vs Rx categorization by modifying "adequate directions for use" for Rx's deemed safe only under MD supervision; authorizes verbal prescriptions and refills - Kefauver-Harris Amendment 1962: adds pre-market approval for efficacy (in addition to safety) and cGMP requirements for manufacturers (adulterated if non-compliant)
State vs Federal Supreme Court
- State Supreme: each state has own; final arbiter for state laws; may have right to have case heard, or may be chosen - US Supreme: chooses to hear certain cases (~100 out of 10,000s; ex: to harmonize law; unconstitutionality; large federal implications; suits bw states)
what did durham-humphrey amendment do?
- created rx and OTC classification by modifying the adequate direction for use - allowed refills - allow oral authorizations
purpose of supreme court
- resolve discrepancy in state rulings - if there is constitutionalists issues - if outcomes have big impact on how the federal government operate
What are all the different ways laws can be made?
1) Federal, state statutory law - made by elected officials (Fed: FDCA, Federal Controlled Substances Act; State: pharmacy practice acts, State Controlled Substances) 2) Local government ordinances - affect business aspects of pharmacy (city bans cig sales at pharmacy; NYC requires counseling in pts native tongue); still very much valid law 3) Judicial law - either via common law (principles not codified as statute, but developed by ruling; Congress may override/alter/codify common law via statute) or stare decisis (ruling sets future precedent) 4) Administrative law - rulemaking through notice + comment process; specialized laws made for specific field (pharmacy)
3 branches of government and purposes (which Article of Constitution creates each?)
1) Legislative: make laws (Congress); Article I 2) Executive: enforce laws (president); Article II 3) Judicial: interpret laws (Supreme court); Article III
4 reasons for the law to step in
1) Prohibit 2) Restrict 3) Encourage specific option 4) Creation of public goods (incentives, or created by gov't themselves) - orphan drugs to tx rare diseases
2 general types of way law deals with issues 1) Reactive regulation - in reaction to something terrible happening (Pure Food and Drug Act 1906; DSHEA) 2) Proactive regulation - in reaction to something conceived of that would be terrible (FDCA, Kefauver-Harris)
1) Reactive regulation - in reaction to something terrible happening (Pure Food and Drug Act 1906; DSHEA) 2) Proactive regulation - in reaction to something conceived of that would be terrible (FDCA, Kefauver-Harris)
what does the FDCA require?
1938 Act created a requirement for pre-market approval of a drug. A manufacturer had to prove that its drug was safe before the drug could come to market. ● 1938 Act did not require that a manufacturer prove that its product was effective. ● 1938 Act required manufacturers to place certain information, directions for use for the consumer, and warnings on drug labeling.
which statute started to require proof of safety and efficacy
1938 food drug and cosmetics act for safety Kefauver-Harries Amendment for efficacy
It is generally easier for _______________ (legislature, agencies) to make law
AGENCIES!!! Remember "I'm a Bill" journey for legislative statutes versus relatively simple notice & comment process for agencies (takes only ~4-6mo) - This is one of the key reasons for agencies having consolidated power --- to be efficient!
how does the law counter natural monopoly established through drug approval process
ANDA process for generic drug through Waxman-Hatch Act
Stare Decisis - When is it binding?
Abiding by rules established in prior cases - Only binding when decision made by directly superior court (but often refer to prior decision regardless anyway)
Administrative agencies - are they unstoppable?
Absolutely not, important checks & balances exist: - Executive: executive appointments; agenda-setting - Legislative: make new/amend statute governing agency; oversight hearings (reprimand agency head); withdraw funding (appropriations) - Judicial: review agency's statutory authority
_______ is law made by agency, while _______ is law made by legislature
Agency - rules Legislature - statutes *both have full effect of law
Notice and comment period - Does agency actually have to read all comments? - What happens if substantive changes are made during the notice and comment period?
Agency does have to review all comments, but can simply reject them - If any substantive changes made → re-do entire notice & comment period (whole 90d, etc.)
By default, all drugs marketed after ________ are classified as _________ (Rx, OTC)
All drugs after '62 are subject to NDA and Rx approval for safety + efficacy..... howeva: - FDA can remove drug from Rx status (and make OTC) if designation deemed not necessary for protection of public health
14th Amendment
Bill of rights applicable to states - prior to 14th amendment, states actually could restrict speech
Majority of cases in pharmacy law are heard in ______ court
Courts of Appeal
Types of court (in descending order of superiority)
Can be federal or state: 1) Supreme Court: final arbiter 2) Court of Appeals: review trial court decisions based on legal errors (wrong law applied, or law doesn't apply); may review facts, but cannot present new facts (will never win based on saying witness lied in trial); super rare to re-open based on new evidence; stare decisis effect 3) Trial courts (district, superior courts): fact-finding (hears case, testimony/documents); convince judge/jury your side is right *very important to consider what court a particular case is being heard in (ex: if Appeals, must be arguing on procedural grounds)
Which law gives Congress the power to regulate drugs? Federal law aims to protect from what 2 things
Constitution - Interstate Commerce Clause to protect from: 1) Adulteration (contamination) 2) Misbranding (label not what's in bottle)
The __________ creates the federal gov't in the US
Constitution - specifically grants certain powers to Fed (if not specified, then they don't have it) - "Certain" powers: may be very broad (ex: interstate commerce clause allows regulation of pretty much all goods) - Short (3-4p), but super vague to confer large amount of power
CVS vs NC BOP
Court of Appeals - Issue: 3 separate CVS pharmacists commit dispensing errors; CVS gets reprimand, but argues beyond statutory authority bc rule says pharmacists (not pharmacies) can be reprimanded - Outcome: BOP wins; w/in statutory authority to revoke, suspend, refuse to renew license or reprimand pharmacist.... reprimand is so much less serious than other punishments, so they're allowed to reprimand pharmacy (if CVS had won case, then BOP probs would have just revoked license); deferential to BOP - Significance: pharmacy is liable for pharmacist actions (just like in Sunscript case); BOP allowed to give less harsh punishments
Sunscript vs NC BOP - Which court? - Issue - Outcome - Significance
Court of Appeals - Issue: pharmacist working under Sunscript licenese commits dispensing error w/ phenytoin resulted in death; both pharmacist + Sunscript permit penalized; Sunscript argues beyond scope of authority to be punished based on vicarious liability (pharmacy itself didn't engage in misconduct) - Outcome: pharmacies act through pharmacists; upholds Sunscript's license penalty (deference to BOP) - Significance: pharmacy and individual can be penalized for SAME misconduct; ambiguity in rule's language to protect public health
Cohen vs Missouri BOP - Which court? - Issue - Outcome - Significance
Court of Appeals - Issue: whether BOP exceeded statutory authority by imposing a penalty against Mr. Cohen; Cohen got 1yr suspension + 5yr probation, BOP finds violations after 5yr probation expired + issues probation extension by 1yr, then revokes license; BOP punishment options: revoke or put on probation up to 5yr - Outcome: Cohen wins -- BOP could have issued new probation (rather than extending) or simply revoked license, but exceeded it's statutory authority by exceeding the 5yr max for probation (non-deference) - Significance: word is everything; had court ruled for BOP, it would set precedent for BOP to hand out any punishment it deemed fit (if NC BOP had heard case, they might have ruled differently..)
In general, courts _____ (have; do not have) deference to agencies - Is this good or bad?
Courts usually have deference to agencies (don't try to tell them what to do) - Deference is good - agencies were created to provide expert opinion for specialized areas; bolsters agency's statutory authority
What are the differences between criminal and civil law? What ends does each serve? Where does professional discipline fit?
Criminal: gov't suing individual for violating societal interests; consequence = punishment (fine, prison, death penalty!) to punish Civil: private dispute; consequence = money for damages (to make another "whole") to compensate professional discipline can git in both categories
which statute created OTC drug
DHA
What happen if Congresses passes as statute that violates the Constitution?
Deemed void by the Supreme Court - Supreme Court will also void laws if Congress exercises power not granted by Constitution
Bicameralism
Division of Congress into 2 chambers (Senate, House of Reps) - designed to be inefficient + create more deliberate laws, that will truly provide societal benefit
How efficacious is considered efficacious enough under Kefauver-Harris amendments?
Effective compared with placebo (not standard of care or other pdts on market)
How can the executive branch influence pharmacy?
Executive Appointment Clause: Presidential appointments to FDA; agenda-setting
Natural monopoly
Exists due to high start-up costs or powerful economies of scale of conducting business in specific industry (classic Pharma!) - Ex: FDA approval is, by nature, a natural monopoly bc others don't want to go through R&D to prove safety/efficacy
what did KHA require?
Expanded the pre-market approval burden to include adequate proof that a drug is effective for its indicated use, not merely safe. ● The KHA also added Good Manufacturing Practices requirements for manufacturers, violation of which amounts to adulteration.
Law tends to step in when the ___________ become so large that intervention is required
Externalities - Policy making is essentially deciding at what point do externalities become significant enough that we need to step in to help steer decisions one way or another
True/False the Supreme Court needs to take all the cases
FALSE a. With the exception of lawsuits between states, the Supreme Court's jurisdiction is discretionary. No litigant has a right of appeal to the US Supreme Court in any case.
T/F anything published by the agency is law
FALSE § Agency publishes things about what they thinks regarding things, but they are not always laws
TRUE/FALSE The US loves monopolies
FALSE!! US law hates monopolies; we have very specific legislation to prevent the natural monopolies when FDA approves a new drug (ANDA created by Waxman-Hatch Act for generic approval)
TRUE/FALSE Only the legislative branch makes law
FALSE!!!!!! Executive branch makes (too much) law, so does judicial through its decisions - Administrative agencies certainly make law through their "promulgation" of rules (after going through notice + comment period) executive: rules judicial: common law
TRUE/FALSE The law is always black-and-white and 100% clear
FALSE; never perfectly effective nor clear; lots of gray area
TRUE/FALSE The US government is built for speed!
FALSE; very intentionally inefficient + deliberate - Checks/balances to prevent tyranny
Case: Stenger Horse Farms asks to buy a mare from Franklin horse farms. He does, but is unhappy when the mare doesn't produce any ponies. Stenger argues he was disadvantaged by information asymmetry and wronged as Franklin knew about his mare being sterile, and needs restitution. - What do ya say?
Franklin Farms wins via caveat emptor ("buyer beware") - While there was information asymmetry, Stenger should've done his due diligence and specified he wanted a fertile mare - Contrast with: counseling about AE (information asymmetry is so great and potential detriment is so significant with serious AE; layperson shouldn't need to know they need to ask about specific AE...... Drew knew better!); medication information asymmetry is different than everyday asymmetry
___________ ______________ is the most common market failure that laws in pharmacy try to correct
Information asymmetry!
which law gives the federal government the authority to regulate drug, approval marketing and pharmacy practice?
Interstate Commerce Clause - FDCA
"I'm just a Bill" journey
It's a long one... - Bill introduced in House → at least 1 committee, debate, lobbying, pass committee vote → House floor vote (new debates, amendments), pass House vote → Senate committees (vote), then Senate floor (vote) (→ conference committee only if senate version doesn't match house version) → Trump vetoes it → Congress can overturn with 2/3 majority in BOTH houses
How much power does the interstate commerce clause give Congress?
LOTS - everything affects interstate commerce d/t nature of global economy - Ex: Swansboro CBD company claims all product made w/in Swansboro so not subject to Congressional oversight --> FALSE; very likely some building blocks (seeds, soil, equipment) came from out of state; or if highly popular, people may from out of state to buy or bring it over state lines - Confers power to regulate drugs, approval, marketing, pharmacy practice (though state legislation governs most day-to-day practice)
Common law
Law based on previous judicial decisions-precedent; non-codified law; still enforceable - Ex: malpractice in pharmacy
Administrative agencies - Describe their legislative, executive, and judicial functions
Legislative: notice & comment period (publish proposed rule + rationale on NC/Federal Registry and Agency website w/ instructions how to comment; 90d comment period) - Judicial: board rulings become de-facto law - Executive: board prosecutes violations
How is a drug's status changed from Rx to OTC? Why would they want to do this?
Manufacturer needs to demonstrate it's safe enough to be used w/o MD supervision --> FDA approves safety --> now OTC - Might preserve market share after patent protection is lost
From a consumer/manufacturer PoV, what are the pros and cons of a natural monopoly within Pharma?
Manufacturer: its great! No competition means you can charge w/e you want (price gouge) Consumer: Bad! 1) Quality + efficiency suffer (no incentive to innovate and improve) 2) High prices, lower availability 3) no control on price
Market failures - Definition, examples
Market failures: individual decisions that produce an undesirable outcomes - "Public" good - needed, but w/o incentive (vaccines, orphan drugs) - Externalities - one's choices that negatively affect others (not vaccinating yourself may put others who can't vaccinate at risk - Natural monopoly - high barrier d/t high start up costs (proving safety/efficacy) - Information asymmetry - one party (manufacturer, HCP) has more info than other (consumer, patient)
Externality - Definition, examples
Negative consequences of ones decisions affecting others (who had no involvement in decision); includes all of the downstream effects (economic, health burdens) - Ex: anti-vaxxer chooses to not immunize kids, who end up giving measles to immunocompromised neighbor - Ex: over-use of antibiotics producing resistance + superbugs - Ex: Purdue falsely promoting opioid safety indirectly triggering opioid epidemic
What should courts consider when interpreting law? drawbacks?
Original intent of the legislature who passed law; may look at: - Committee reports that produced given law - Consider reason why law was proposed in first place (motivation and intent) - look at the plain words information may not always be available
what did prescription drug marketing act do? food and drug administration amendment act?
PDMA: regulatory scheme for drug sampling FDAA: require manufacturers post marketing clinical studies to monitor for risks undetected during the pre-market approval process
What are the costs of setting up legal systems entirely preventative in nature? Reactive?
Preventative: lack of choice w/o consequences; inability to innovate/take risk Reactive: everyone does w/e they want; chaos! *careful balance bw pro/reactive is crucial
Rx vs OTC categorization
Rx if: - deemed safe only under medical supervision (toxicity, method of use, habit-forming, etc.) - subject to NDA approval process (disease state claim)
Information asymmetry
Situation in which one party is more informed than another bc of having more info - MANY laws (esp in regards to mislabeling) seek to remedy information asymmetry for consumers
How did the Pure Food and Drug Act of 1906 address the sulfanilamide elixir disaster?
Sulfanilamide elixir made with diethylene glycol (antifreeze) - Only could address on grounds of mislabeling, since elixirs are supposed to contain EtOH, which this did not (could have been labeled liquid and would not have addressed) - However, it did prompt the creation of the FDCA, which then required proof of safety prior to marketing
_____________ clause says that ________ (state, federal, local) law prevails when they are in conflict
Supremacy clause - Federal trumps state laws when in conflict; state law trumps local law
Heckler vs Chaney - Which court? - Issue - Outcome - Significance *which case is this similar to?
Supreme Court - Issue: death row inmates were being executed via lethal injection using drugs not labeled for execution, sued FDA since drugs weren't proven safe + effective - Outcome: FDA wins; agencies have discretion about what to enforce, and they chose not to enforce this one (but also - how could safety ever be proven for a lethal injection?) - Significance: agencies are best suited to decide how to allot resources and enforce own rules (courts can't compel agencies to take action) *similar to KB pharmaceuticals, where court did not compel FDA to act against compounding pharmacies
United Pharmacal vs Missouri BOP - Which court? - Issue - Outcome - Significance
Supreme court - Issue: Pharmacal selling animal drugs w/o pharmacy license; BOP argues statutory authority over animal drugs, while Pharmacal says BOP's rule about animal drugs came from a website FAQ - Outcome: FAQ is not a rule (would have to go through notice + comment, etc.) and has no legal effect; Board can take action based on interpretation of rule, not on grounds of FAQ (statute doesn't distinguish human v animals, so license is needed) - Significance: agencies make law through rules, but must go through procedure w/ notice + comment period; agencies often publish their thinking on particular matters, but it does not have the effect of law (though this doesn't mean they won't go after you for violating rule/law in place)
TRUE/FALSE If someone gets put in jail for beating someone up and causing permanent damage under criminal law, they can still go to civil court to pay for damages for injuries suffered
TRUE!!!
first amendment speech clause effects to drug industry
The principal means by which the federal government regulates prescription drugs is by control of its marketing - i.e.,regulation of certain speech. now can only limit to a certain extend.
Why would agencies make FAQs on their website?
To avoid going through the trouble of rule-making, but want to inform those in field of agency thinking and encourage compliance (not legally binding) - Agency can take action against you if you don't comply, but not on grounds of FAQ (same rationale as FDA releasing Guidance Documents)
what does local government ordinances affect in pharmacy?
more of the business aspect of pharmacy, less on pharmacy practice
when one's free choice negatively affects another person or society as a whole, but the individual does not pay a price (eg, pollution)
externality
what are the purpose of trial court?
hear the cases in the first instance - district court in federal system - find out what are the facts, how to apply law to the fat and reach a decision - conduct trial, look at evidence, listen to testimony
why is it hard to make purely proactive law?
impossible to imagine all risks in the filed of pharmacy
Situation where one party has more information than the other, leading to an advantage or inability for fair exchange
information asymetry
what is the common law? purpose of it?
legal principles that are not codified in sautés. they are developed on a case-by-case basis, typically to guide resolution of private disputes eg. malpractice
who creates the administrative agencies? where is it housed
legislature create it through statutes housed in executive branch
situation where there is a high barrier to entry such that "start ups" have too much upfront investment required to compete
natural monopoly
is the PFDA effective to protect safety and efficacy?
no PFDA did not require pre-market approval of drugs. Drugs could be freely marketed by a manufacturer unless and until the federal government proved that the drug was adulterated or misbranded. bad things have already happened agency needs to prove the information is wrong before removing the product
do you get a second trial at the court of appeals?
no unless the other side hide pertinent facts during the original trial they won't find new facts
is the pharmacy automatically liable for actions of its pharmacists
no, but the agency/court could choose to
Was the 1906 PFDA sufficient to deal with the sulfanilamide issue? Did it? If so, why the creation of a new statutory scheme?
no, they could just omit the information
Is a statute or regulation capable of addressing all possible factual scenarios? Should it be?
no. - different interpretation of law based on ppl's judgement, value, common sense, experience - sometimes written vaguely on purpose to allow future interpretation
when is there really a conflict between federal and state law? Does a mere difference in federal and state law necessarily mean that the two conflict?
not always, just because they are different, doesn't mean they conflict with each other needs to prove conflict
what incentive did a manufacturer have to place any labeling on its product under PFDA?
not really much The statute was ineffective. While it prohibited knowingly false statements concerning foods and drugs on labeling, it did not require that manufactures place any information on that labeling Furthermore, the PFDA prohibited only knowing misstatements. Claims of ignorance or simple mistake thwarted effective prosecution.
take away point from the Cohen case
o Agency have enormous power within a relative a small sphere defiend by the statute, if we are confer this power to an agency, the agency need to be very careful in exercising their power according to their statutory authority o This is a show of how the judiciary branch check on the agency
What role do lawsuits have in setting agency enforcement priorities?
o Each administrative agency have a lot of statutes to enforce, they could not possibly enforce in every single case with limited resources o The administrative agency have relative expertise to prioritize the cases and choose what to enforce, the court do not decide that Court does not decide what the agency do or choose not to do, the agency can make that decision
is US government opt in or opt out?
opt in - if the constitution does not grant authority to the federal government, feds do not have the power - limit how the exercise the power too by the Bill of Rights
what should we employ when interpretation the laws?
profesional judgement and common sense
role of law
provide guidance for people when they make choices in life
Goods that are needed by all, but not incentivized (or possible) for an individual to provide
public goods
which statutes started to require truthful information
pure food and drug act
purées of the courts of appeal
review, upon the appeal of a losing party, the decisions of trial courts.
what is the backbone of federal drug regulation
the food, drug and cosmetic act of 1938
why do we have laws? to control _____ ______
to control market failures
what does the PFDA require?
truthful statement do not require pre market approval of safety and efficacy
is it hard or easy to pass a law?
very hard since it needs a lot of agreement intentional
Under what circumstances is it proper for a court to depart from prior decisions? In other words, does one rule resolve all disputes?
when the material facts are the same you need to prove the facts are the same
when do law step in to remedy information asymmetry
when there is a great chance that the other party can't acquired and understand the information
can common law be altered?
yes, legislature could override, alter, or codify common law
