Law Quiz #2

risk

"Strict liability" is not common in the law. It is only used in circumstances or enterprises in which the great ___ associated with the enterprise requires the law to be very strict about punishing unsafe execution of that enterprise

misbranding

"_______" is claiming something prohibited by federal law, or omitting to say something required by federal law.

misleading government interest government interest public interest

4 Factors that must be true for commercial speech to be protected 1. Speech must not be _____ or leading to unlawful activity 2. The _____ ____ in the regulation must be substantial 3. The regulation must directly advance the _____ _____ 4. The restriction of speech must not be more extensive than is necessary to serve the ___ _____

biosimilar

A "generic" biologic product is termed a(n) _____

risk

A drug may be deemed "adulterated" even if pure on individual analysis. How is this possible, and why? Because it is impossible to check every product. So an unacceptable ____ of adulteration during the manufacturing process is enough to consider the product as adulterated.

MedWatch

A voluntary adverse event reporting system in conjunction with the FDA

label labeling (package inserts, leaflets, ads)

A(n) ____ is the thing that is actually affixed to a drug product's container ("sticker") _____ is anything that a manufacturer says about its product

DC circuit due process implicit

Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach Who heard the case? Problem: They argued that terminally-ill patients have the right to access investigational drugs through the ____ ____ clause, basically the right to self-preservation Outcome/Significance: FDA wins. Court rejects notion that certain rights, including access to investigational drugs, are _____ in the constitution

adulteration, misbranding

According to the FD&C Act, what two primary actions are prohibited in the marketing of products?

cosmetics

According to the FDA, _____s are articles to be rubbed, poured, sprinkled, sprayed on, or otherwise applied to the body (except soap)...for cleansing, beautifying, promoting attractiveness, or altering the appearance

ok

Adulteration Definition: filthy, putrid, decomposed (contamination) manufactured in contaminated facility strength, quality, or purity differs from what it claims (say ok)

BOTH

Adulteration or misbranding- Simvastatin 10mg labeled as simvastatin 15mg?

facility, means facilities

Adulteration provision is, most respects, designed to regulate the _____ and _____ of production, and not the product itself. This provision exists because it would be impossible for the FDA to check every product. It's much easier for the FDA to regulate ____s that make products

misbranded name brief summary fair balance

Advertising Regulations to Professionals (found in Section 502(n) Product is ______ unless the manufacturer includes in all advertisements and other descriptive printed matter a "true statement" that includes: -established _____ of the drug -formula -a "____ _____" of information concerning side effects, contraindications, and effectiveness. This summary must present a "_____ ____" between, on the one hand, side effects and contraindications and, on the other, effectiveness -for broadcast media, the "true statement" may be condensed, and need only include information about major risks so long as there is "adequate provision" for dissemination of approved labeling

labeling information 4 phone number, website, referral to source of reading about drug, referral to healthcare provider

All regulations are the same for advertising drugs to consumers and professionals EXCEPT that when advertising to consumers, you must also include An adequate provision to obtain ___ ____, and there must be at least ___ sources for that, which are what?

3 substantially similar 1976

By default, all new medical devices are Class ____, unless it can be proven that a new device is _____ ____ to a device that was created prior to ______

supplement

Classify the following product as drug, supplement, or food: Vitamin C to support immune health

drug

Classify the following product as drug, supplement, or food: Vitamin C to treat scurvy

pure food and drug act (so burden is on FDA to remove from market)

DSHEA and subsequent rulings essentially set up a system governing dietary supplements in the same way that drugs were regulated under which piece of legislation?

disease drug

Dietary Supplements cannot do the following things: - No ______ claims (dx, tx, cure, etc.) - Cannot contain approved ____ product

prescriber consumer

Durham-Humphreys made the exception that prescription drug products had to have adequate information for use from the ______ standpoint All OTC drugs have to have adequate instructions for use for the drug ____

articles supplier structure, function food

FDA Definition of a Drug: _____s intended by the ______ for the diagnosis, cure, mitigation, treatment or prevention of disease in any animal (including man); or intended to affect ____ or ____ of the body, except _____

ok

FDA Device Definition: Instrument, apparatus, implement, machine, contrivance, implant, in vivo reagent or anything similarly related intended for dx, cure, mitigation, tx, prevention of disease OR to affect structure/fcn that can't be achieved through chemical action and not dependent on metabolism for purposes (say ok)

misbranding

Failing to provide the appropriate patient package insert (PPI) or written medication guide is what type of FD&C violation?

ok

Federal requirements for labeling drugs that are dispensed from the pharmacy. These are the floor, not the ceiling, for labeling requirements (say ok)

nutrient deficiency prevalence structure, function mechanism structure function well-being

Four claims that a dietary supplement can make: 1. Statements that the product will benefit a classical ____ _____ disease as long as it also discloses the _____ of the disease in the United States 2. Statements that describe the role of the dietary supplement in affecting the ____ or _____ of the body 3. Statements that characterize the documented _____ by which a nutrient or dietary supplement acts to maintain _____ or ___ 4. Statements describing the general ____-_____ from consumption of a nutrient or dietary ingredient

pharmaceutical (drug, dose, dosage form) bio (Cmax, Tmax, AUC within 20%) cGMP

Generic drugs must demonstrate 1. _____ equivalent 2._____ equivalent 3. Must demonstrate _____ (abbreviation)

2 5

Hatch-Waxman made the ANDA process. In order to compensate for lost revenue to pharmaceutical companies, they instituted in the act an extension on patent from ___ to ___ years once it starts to be marketed

15

In 2006, Congress required manufacturers, packers, and distributors of dietary supplements to report "serious adverse events" to FDA within ____ business days. All dietary supplement labeling must include a means of contacting the supplier to report adverse events.

clinical trials informed consent

Investigation Drug Status: It is meant for drugs under ____ ____ ___ ____ is required for patients to receive the drug

substantially similar 501(k) patent protection

Is it better to get approved as a medical device or drug? 1. Device Pros - if you can prove that it's ____ ____ to a device approved before 1976 through the ____ pathway, that might be easier 2. Drug Pros - If you want ___ ___ afforded to an innovator drug

information asymmetry

Labeling is meant to correct which market failure?

1976 510(k)

Medical Device Amendments - Devices marketed prior to ____ get to stay on the market - Manufacturers can use _____ submission for device that is "substantially equivalent" device approved before this legislation

Class 1 Class 2 Class 3

Medical Device Amendments of 1976 Classification of devices ___ ____: low harm potential; registration + notification system (toothbrush) ____ ___: higher risk; specific performance standard, but no premarket safety/efficacy approval _____ ____: life-supporting or sustaining, or serious risk of harm (ventricular pump; insulin pump); requires premarket approval (like drugs)

misbranding

Most violations of the FD&C act are violations of (adulteration/misbranding?)

561

National section _____ allows eligible, terminally-ill pts access to experimental drugs after phase I

US Court of appeals ephedra unsafe reactive

Nutraceutical v Eschenbach: Who heard the case? Issue: FDA banned ____ sales, company claimed that FDA didn't provide significant enough data to prove it was unsafe Outcome/Significance: FDA does have the authority to pull _____ dietary supplements from the market. Shows the ___ nature of DSHEA

US Court of Appeals starch blockers drug kidney beans drug structure/function

Nutrilab v. Schweiker Who heard the case? Issue: FDA decided that "____ _____s" were a(n) _____ because they were marketed as such. Nutrilab claimed it was not because it was derived from __ ____ Outcome/Significance: Court decided this product was in fact a(n) ____ because it was intended to modify _____/____ of the body

directions for use inactive ingredients (actually all components?) false or misleading

Requirements for a drug product not to be misbranded: 1. adequate ____ ______ ___ (only for OTC) 2. list of _____ _____ 3. no ____ or ____ information

know source

Section 303(c) provides an exception for pharmacists for providing adulterated/misbranded products provided the two following things are true: 1. The pharmacist did not ___ that the drug was adulterated/misbranded 2. The pharmacist is willing to disclose the ____ of the adulterated or misbranded article upon request.

misbranded adulterated

Simvastatin 10mg labeled as simvastatin 15mg is both adulteration and misbranding: _____ because the product differs from what label says _____ because the strength differs from what claimed

scope of practice

States generally have laws regarding by dispensing and prescribing of drugs. These authorities are typically defined under a(n) _____ _____ _____

TRUE (though lesser than individual speech)

TRUE or FALSE: "Commercial speech" is entitled to First Amendment protection

FALSE

TRUE or FALSE: A biosimilar is interchangable for the original product in terms of pharmacists dispensing

TRUE

TRUE or FALSE: A pharmaceutical company cannot advertise for an off-label use of their medications at a company-sponsored educational program

TRUE

TRUE or FALSE: All prescriptions must be accompanied by the number for MedWatch

FALSE (only manufacturers)

TRUE or FALSE: Both manufacturers and HCPs are required to report ADRs to the FDA

TRUE (slightly different than strict liability)

TRUE or FALSE: Corporate officers are specifically liable under language in the FD&C act for the actions of their subordinates that violate the FD&C act

FALSE

TRUE or FALSE: Cosmetics have a pre-market approval process

TRUE

TRUE or FALSE: Currently, all newly-approved drug products are prescription only

TRUE

TRUE or FALSE: Federal law has little to say about who can dispense drugs

FALSE (this is the definition of strict liability)

TRUE or FALSE: If a company was not aware of an adulteration of their product occurring during manufacturing, then they cannot be held liable

TRUE

TRUE or FALSE: It is easier to get something to market if you claim that it is a food instead of a drug

TRUE

TRUE or FALSE: Manufacturers are not obliged to give experimental meds to terminally-ill patients under "Right to Try" laws, and if they do provide them, they can charge for them

FALSE (really just enables them to ask)

TRUE or FALSE: Manufacturers must provide drugs to terminally-ill patients under "Right to Try" laws

TRUE (just hasn't ever been enforced for hospitals, long-term care, etc.)

TRUE or FALSE: Technically, all unit dose packaged medication must comply with FDA labeling requirements

TRUE

TRUE or FALSE: The FDA can order recalls

FALSE (has pre-approval process, but optional)

TRUE or FALSE: The FDA has the authority to review all advertisements by pharmaceutical companies to advertise their products before they are released to the public

TRUE (though it did not before 2007)

TRUE or FALSE: The FDA has the statutory authority to require phase IV post marketing studies

FALSE (it is the INTENT of the SUPPLIER)

TRUE or FALSE: The classification of a drug is based on whether or not the purchaser intends to use it as a drug

TRUE

TRUE or FALSE: You can be held criminally liable for violations of the FD&C act

articles food drink chewing gum articles

The FDA definition of food: ____s used for ___ or ____ for any animal; ___ ____; any part of such _____s

Section 303(c)

There is an exception to "strict liability" due to the FD&C act. Pharmacists have a "good faith" defense to adulteration and misbranding if they disclose the source of the adulterated or misbranded article upon request. What is this exception called?

Good Manufacturing Practices

There is now a FDA rule that requires dietary supplement manufacturers to comply with _____ ______ ____s.

Federal Anti-Tampering Act (1982) Tylenol/cyanide

What piece of legislation? Requires certain OTC products to have tamper-resistant packaging (evident if tampered with)- Prompted by _____/______ scare

US supreme court terminally-ill safe effective terminally-ill

US vs. Rutherford Who heard the case? Problem: _____-___ patients who wanted to be able to take an unapproved drug for cancer tx. Outcome/significance: Court sided with FDA, said "____ and ___" still has meaning for these patients. Also, really difficult to prove what a(n) "____-___" patient is

ingestion vitamin mineral herb, botanical amino acid

Under DSHEA, a dietary supplement is defined as a product that is intended for ____, is intended to supplement the diet, and contains any one or more of the following: • A _____ • A _____ • An ____ or other ___ • An ___ ____ • A dietary substance for use by humans to supplement the diet by increasing the total dietary intake • A concentrate, metabolite, constituent, extract, or combination of the previous (§ 201(ff); 21 U.S.C. § 321(ff))

abbreviated new drug approval (ANDA)

What application is used for the approval of generic drugs?

FDA

What happens if a therapy has both drug and medical device features? (what is it treated as?) The ____ decides. Usually, if it contains a drug, it's treated as a drug

strict liability

What is this term? "Violation of the FD&C Act does not require that the violator have known that its actions were illegal, or to have intended that its actions be illegal."

natural monopoly (bc no one would have the incentive to get a new device approved, it's kind of like ANDA process for drugs)

What market failure did the clause in the Medical Device Amendments of 1976 for 510(k) approval status remedy?

Kefauver-Harris amendment (1962)

What piece of legislation introduced cGMP?

Medical Device Amendments of 1976

What piece of legislation? - Devices marketed prior to '76 get to stay on the market - Manufacturers can use 510(k) submission for "substantially equivalent" to pre-76 device

Food and Drug Administration Amendments Act of 2007 ("FDAAA")

What piece of legislation? Gave the FDA the statutory authority to require post-marketing studies?

Hatch-Waxman

What piece of legislation? Made the ANDA process

Dietary Supplement Health and Education Act of 1994 (DSHEA)

Which piece of legislation? Generally commands the FDA to treat dietary supplements as foods rather than drugs.

Durham-Humphrey Amendment (1951)

Which piece of legislation? Authorized verbal prescriptions and refills