Abood Chapter 1-4 Before MT
Abood Chapter 1
Market failures: Reasons govt needs to regulate drugs
Ø information assymetry - consumer is uninformed as to the value of the goods.
Ø externality - production or consumption of a good effects someone who does not consent to it's effects.
Ø natural monopoly - fixed costs are high relative to variable costs.
Ø public goods - when the goods are nescessary and beneficial to the public, but private business will not supply. (examples are Orphan drugs and vaccines.
DeMinimis Violations of the Law (minor violation that does not need punishment)
F.R. = Federal Register: daily publication listing federal actions
C.F.R. = Code of Federal Regulations: annually revised compilation of final regulations
Stare decisis means “ to abide by decided cases.” It applies to lower courts w/in that courts jurisdiction.
Common Law = laws made by the courts. Is based on precedents "stare decisis".
Supreme court has original jurisdiction cases that affect ambassadors, public ministers, consuls, and when the state is a party. It also appellate jurisdiction in almost all cases.
Summary judgement: either side may ask for one at any point during trial, asks judge to rule w/o trying facts, attempts to prove to oppositions case is w/o merit even if the facts are considered
Directed verdict: after plaintiff presents cause, defense acts for directed verdict, claiming that the plaintiff did not introduce sufficient evidence to justify the complaint, if granted the defense wins
If a case is cited as 361 P.2d 944 (WA 1997), what does that mean?
Ø State level trial court decisions not usually reported
Ø Most state and federal appellate opinions and many federal trial court opinions are report
Ø Volume 361, 2nd edition of Pacific regional reporter, page 944, state of WA, year 1997
Ø F., F.2d, F.3d are federal court of appeal decisions from Federal Reporter, w/ edition #.
Ø F. Supp is a federal district court opinion.
Ø U.S. or S. Ct. is a US Supreme Court opinion
Ø Regional reported abbreviations: P, Pacific; NW, Northwestern; NE, Northeastern; A, Atlantic; SE, Southeastern; So, Southern
Abood Chapter 2
label: info required directly on the container or wrapper
labeling: includes the label and other info accompanying the drug, ie the package insert; all labels and other written, printed, or graphic matter upon any article. Literature deemed to accompany the product. Stricter laws for labeling than advertising because must be FDA approved
Advertising: literature deemed to not accompany the product.
USP: standards for strength, purity, stability, etc; published by scientific experts
HPUS: standards for homeopathy products; private, non-profit organization of experts in homeopathy
Ø Under the FDCA, a drug recognized in the USP/NF or HPUS must meet ALL compendia standards, or else it will be considered misbranded or adulterated.
direct regulation: decision is made for the people, ie not allowing a specific drug on the market
indirect regulation: help people make their own decisions by providing accurate info through proper labeling
Adulteration:
Ø consists of any filthy, putrid, or decomposed substance
Ø exposed to possible contamination
Ø manufacturing did not conform to CGMP; contains unsafe color additive
§ -Focuses mainly on manufacturing
Misbranding:
Ø labeling is false or misleading
Ø No name and place of the manufacturer or inaccurate statement of the quantity of the contents
Ø any required info NOT on label
Ø doesn’t include established name, quantity of each active/inactive ingredient
Ø doesn’t bear adequate directions for use (adequate warnings)
Ø Focuses on representation made by manufacturer on labeling
adequate directions for use: directions under which a layperson can use the drug
adequate information for use: required for Rx drugs, enable a practitioner to use the drug safely.
NDC number: a unique # required on all Rx and OTC drug labels/labeling,
Ø 1st 5: manufacturer; last 5: drug name, pack size, type of drug
Must a physician or pharmacist report an adverse drug reaction or drug quality issues to the FDA?
Ø No, both types of reporting are voluntary, although a moral obligation of health care professionals
Class I, II & III medical devices
Ø Class I: require least regulation, pose least potential harm, -needles, gloves, toothbrushes
Ø Class II: must meet specific performance standards established by the FDA.
· insulin syringes, infusion pumps, thermometers, diagnostic reagents
Ø Class III: need premarket approval, are life-supporting or life-sustaining or present unreasonable risk of illness or injury
· pacemakers, soft contact lenses, replacement heart valves
· devices not marketed before 1976 fall into this class, unless the FDA determines otherwise
Are cosmetics subject to premarket approval?
Ø No, FDA may remove it if its misbranded, adulterated or a health hazard
Ø labeling requirements: -list of ingredients on outside of package, Some need warnings
Lanham Act -prohibits use of "any false description or representation, including words or symbols"
1906 – correct labeling and ingredients required
1938: drugs now must prove safety, NOT retroactive
1938-1962: RETRO requirement to show safety and efficacy
1962: Must now show safety and efficacy, also DESI created. RETROACTIVE to 1938
Ø DESI: governments method of dealing with the retroactivity (not a law),
· reviewed 1938-62 OTC drugs by class, Rx drugs required individual ANDA
· ANDA: For 1938-1962 generics to show bioequivalence and bioavailability
· Paper NDA: For >1962 drugs to show safety and efficacy prior to approval
1984: PTRA/DPC (Waxman-Hatch amendment)
Ø ANDA/PNDA combined into ANDA and made it law. A result of public demanding generics
gives parent drugs longer patents and market exclusivity
3 methods a drug can go from RX to OTC
Ø MFG can submit a suplimental NDA
Ø can petition the NDA ( if a similar drug was approved)
Ø Can be switched through OTC review process (usually switches all drugs in a class)
Abood Chapter 3
Collateral measures test: will the consumer recognize that they need to see a MD if something goes wrong while they are taking it. (part of Durham-humphrey determining if OTC or Rx)
PPI (Patient package insert): 4 categories that require FDA approved written pt information:
Ø estrogen, progesterone, DES, IUD (come from MFG and must be given to pt.)
Ø There are only about 5 meds that require PPI's to be given to patients.
Medication Guide Program (totally separate from PPI)
Ø Drugs with serious adverse events
§ 2 parts to Med guide program
· Med guide: those drugs with serious and significant adverse events
¨ FDA says 5-10 drugs per year qualify
· That useful written information is required for all other drugs.
¨ FDA wanted to decide what to provide but let private sector produce the information. (congressional decision)
¨ Should be given out every time.
¨ written information is not required though you put yourself at increased risk for lawsuit.
Drug Rating (A vs B) Only a guide, not the LAW - but may be evidence in court
Ø A = are considered therapeutically equivalent to a reference drug product.
Ø B = are not considered therapeutically equivalent for various reasons including that they may have documented bioequivalence problems to a reference drug product or there may be a significant potential for such problems and no adequate studies demonstrating bioequivalence.
Ø Generic drugs marketed after 1984 and approved under an ANDA will not have a B rating b/c PTRA requires that generic drugs must demonstrate proof of bioequivalence before approval . So all Generics approved after 1984 are A rated!!
Pharmaceutical equivalents: contain the same active ingredients, are identical in strength and are of the same dosage form
v Pharmaceutical + Bioequivalent = A rated
v Pharmaceutical but NOT Bioequivalent = B rated
Therapeutic equivalents: pharmaceutical equivalents expected to have the same clinical effect and safety.
Ø (Pharmaceutical equivalents that are bioequivalent are assumed therapeutically equivalent.)
NTI (narrow therapeutic index) drugs: An NTI is defined as one where there is less than a 2-fold difference in the median lethal dose and median effective dose; or there is less than a 2-fold difference in the medial lethal dose or minimum effective concentrations in the blood.
Drug samples: Any sample drug in a retail pharmacy shall be considered evidence that the sample was obtained illegally.
Strict Liability: Assumed guilty and liable until proven innocent.
Abood Chapter 4
3 Legal instruments
Ø NOI: notice of inspection: Must have permission; must be during regular business hours.
Ø AIW: administrative inspection warrant: Cannot be refused but requires probable cause defined as “valid public interest.” Drug diversion or record keeping violations constitute probable cause. Can only be delivered during the day. Created by supreme court to allow administrative agencies to inspect commercial premises and for administrative inspections.
§ CSA (controlled substance act) created the AIW. Only the DEA needs an AIW or SW. FDA does not require these documents and can inspect whenever they want.
Ø SW: Search warrant: requires probable cause, law enforcement must convince a judge that a reasonable person would believe that a crime has been or will be committed on the premises or that evidence relevant to a crime exists at the premises. SW can be served any time, day or night, store open or closed.
State board says can not refuse a STATE warantless search. Can refuse the DEA warantless search but they will go get an AIW. Must have an NOI at a minimum. If they do not get an NOI and you refuse but they insist, let them go and it will all be inadmissible.
California law allows warantless searches because the AIW process allows excemptions (liscensing exemption) to the search warrant.
Pseudoephedrine Law in California
Ø Can sell 3 containers or 9 grams (300 tablets).
Preemptive doctrine: State law should not be less strict than federal law.
Narcotic: A natural or synthetic opium, opioid, or derivative (poppy, coca, cocaine etc.).
5 schedules?
Ø I: high potential for abuse, no medical use in US
Ø II: high potential for abuse, may lead to severe physical or psychological dependence.
Ø III: less abuse than CI/CII, moderate/low physical or high psychological dependence.
§ many have CII as active ingredient, but is a combination product or is a lower dose. The drug’s abuse potential is not great enough to warrant being CII.
§ Not more than 1.8g of codeine per 100ml, or not more than 90mg per dose
Ø IV: low abuse potential, limited physical or psychological dependence.
Ø V: low abuse potential, limited physical or psychological dependence.
· changing dose form (tablet to suppository) can lower the classification
· Not more than 200mg of codeine per 100ml or 100g per dose
Two approaches can take to equal protection argument
Ø strict scrutiny approach: If can get court to buy into this your likely to win. Must prove either suspect classification or that a fundamental right has been violated. Burden of proof is on govt to show a compelling govt. Interest.
Ø Rational Basis approach: Said state cannot make a rational basis argument that justifies keeping it away from him. This requires a much lower burden of proof for the government.
Individual practitioner = IP = physician, dentist, vet, or other person licensed/registered to dispense CS (not RPh, pharmacy, or institutional practitioner) – (Think of a person that writes prescriptions)
Practitioner: Physician, dentist, vet, researcher, hospital, pharmacy, or otherwise licensed (not RPh!).
Dispenser: IP, institutional practitioner, pharmacy or pharmacist. All kinds of practitioners
institutional practitioner: Hospital or other person (other than an individual) authorized to dispense a CS but not a pharmacy
Pharmacist is not any of type of practitioner!!
Section 841: drug traffickers Section 842: record keeping violations
DATA is the Drug Addiction Treatment Act:
Ø Exception to the rule that CS may not be prescribed or dispense for opioid addiction other than in OTPs. Allows “qualifying physician” to prescribe and dispense meds approved by the FDA for maintenance or detox tx. Drugs approved were buprenorhpine sublingual tablets (Subtex) and buprenorphine-naloxone tablets (Suboxone).
Ø Requirements: a QT is defined as a physician certified in addiction psychiatry or addiction medicine or at least 8 hrs of authorized training in tx and management of opioid-dependent pts.
Ø MD’s must obtain a special DEA number to prescribed, may not tx more than 30 opioid-dependent patients