1.2 The Food Drug and Cosmetic Act

currently, how are FDA commissioners chosen?

direct appointments or senate approvals

what led to the formation of the pure food and drug act of 1906?

hella random drug concoctions were just out there

no one knew the ingredients

advertising was unlimited

what was the purpose of the pure food and drug act of 1906?

reduce public risk

reduce misbranding of ingredients

reduce unfounded claims

set purity standards

the food and drug act of 1906 ended up causing…

manufacturers to remove ingredients from printed labels (bc fake claims cannot be made if there are no ingredients labeled)

nothing done for cosmetics or medical devices

in 1912, an amendment was made to the pure food and drug act of 1906, what did it add?

prohibited false and fraudulent efficacy claims

why did the amendment made in 1912 to the pure food and drug act of 1906 not really work?

1912 amendment: prohibited false or fraudulent efficacy claims

burden of proof was on the government

innocent until proven guilty

the food, drug, cosmetic act of 1938 was passed in response to what issues?

sulfonamide leading to death in 1937

ongoing drug abuse and misuse since the 1920s

the food, drug, cosmetic act of 1938 defined what 5 things?

what a new drug is

how a new drug was approved for human use

required certain products to have a batch process

adequate use interactions and warning of abuse potential

included medical devices and cosmetics

the food, drug, cosmetic act of 1938:

limited due to a loophole for…

current products

the food, drug, cosmetic act of 1938

limitations

current products not required

need to only document safety

created an Rx only class of medication

application to intrastate state commerce

the Durham Humphrey Amendment of 1951:
purpose

clarified the role of prescriptions and pharmacists

the Durham Humphrey Amendment of 1951:
effect on drug dispensing

only dispensed on order from an authorized person

the Durham Humphrey Amendment of 1951:
effect on refills

may have refill sif authorized

the Durham Humphrey Amendment of 1951:
clarified that Rx’s need…

labeling to show only prescription

the Durham Humphrey Amendment of 1951:
effect on OTC meds

clarified their status

Kefauver-Harris Amendment 1962:

requirements for testing

extensive animal, pharmacological and toxicological testing PRIOR to being used in humans

Kefauver-Harris Amendment 1962:

requirements for making new drugs

submission of IND (investigational new drug form) by a new drug application (NDA)

Kefauver-Harris Amendment 1962:

requirement for the effectiveness of drugs

must be shown

Kefauver-Harris Amendment 1962:

requirements for drugs approved before 1938

had to show effectiveness

Kefauver-Harris Amendment 1962:

requirements for advirtistings

regulated by FDA and not OTC

Kefauver-Harris Amendment 1962:

requirements for trials

informed consent

Kefauver-Harris Amendment 1962:

requirements for SE

must be reported

Kefauver-Harris Amendment 1962:

requirements for manufacturing

must be good

the medical device act of 1976:

purpose

created classification system for devices to get rid of bad devices

the medical device act of 1976:

created a class system for devices that was based on…

specific function

performance standards

pre-market approval requirements

conformance with good manufacturing processes

adherance to record and reporting requirements

the orphan drug act of 1983:
purpose

created to provide incentives for drug makers

the orphan drug act of 1983:
what is an orphan drug

drug that was made for a disease that impacts less than 200k of ppl in the US

the orphan drug act of 1983:
incentives

tax incentives and licensure incentives

Drug Price Competition and Patent Term Restoration Act of 1984:

purpose

to create generic medications that do not cost as much and extend the patent life of some drugs

Prescription Drug Marketing Act of 1987:

why was it passed

black market

Prescription Drug Marketing Act of 1987

requirements

tracking of samples

state licensing of wholesalers

Prescription Drug Marketing Act of 1987:

banned / prohibited what things

hospitals from selling their stocks

reimportation of Rx drugs

Nutrition Labeling and Education Act of 1990:

why was it made

in response to unregulated food claims

Nutrition Labeling and Education Act of 1990

what did it accomplish?

regulation of food claims and supported food claims

Nutrition Labeling and Education Act of 1990:

gave power to the ____ to regulate food

FDA

Prescription Drug User Fee Act of 1992:

purpose

ability of the FDA to tax companies

Prescription Drug User Fee Act of 1992:

effect on time to market for new drugs

reduced

Prescription Drug User Fee Act of 1992:

benefits ______

large companies

Prescription Drug User Fee Act of 1992:

T or F—> fees can be waived

T

Dietary and Supplement Health Education Act of 1994:

why was it passed

to force the FDA to step back

Dietary and Supplement Health Education Act of 1994:

defined…

dietary supplements

Dietary and Supplement Health Education Act of 1994:

made the FDA _____

not regulate supplements as drugs

Dietary and Supplement Health Education Act of 1994:

weekended the ability of the FDA to…

regulate supplements

FDA Modernization Act of 1997:

purpose

help the FDA do its job

FDA Modernization Act of 1997:

encouraged…

pediatric trials

pharmacy compounding

FDA Modernization Act of 1997:
expedited ….

reviews and approvals for fast track drugs

FDA Modernization Act of 1997:

made the NIH start of a list of…

clinical trials for serious diseases

FDA Modernization Act of 1997:

clarified…

legend drug labeling

FDA Modernization Act of 1997:

got rid of what warning label

“may be habit forming”

FDA Modernization Act of 1997:

ruled what to be unconstitutional

off label usage

Food and Drug Administration Amendments Act of 2007:

purpose

discretion of what the FDA could do with PDUFA funds

Food and Drug Administration Amendments Act of 2007:

required…

reporting of all trials

Food and Drug Administration Amendments Act of 2007:

allowed for more ____

label changes

Food and Drug Administration Amendments Act of 2007:

required which important monitoring program

REMS (risk evaluation and management strategies)

Family Smoking Prevention and Tobacco Control Act of 2009:

allowed the FDA to regulate what three things

manufacturing, distribution, and marketing

Family Smoking Prevention and Tobacco Control Act of 2009:

grandfathers in products that were marketed before _____

2007

Family Smoking Prevention and Tobacco Control Act of 2009:

blocks all flavoring of cigs except for…

menthol

FDA Safety and Innovation Act of 2012 (FDASIA):

purpose

reauthorizes PDUFA

FDA Safety and Innovation Act of 2012 (FDASIA):

added…

new generic fees

power to inspect and act on manufacturers in the US and outside

FDA Safety and Innovation Act of 2012 (FDASIA):

blocks…

importation of adulterated products

Drug Quality and Security Act of 2013:

also called…

drug supply chain security act

Drug Quality and Security Act of 2013:

purpose

regulates compounding

Drug Quality and Security Act of 2013:

began a ______ that must be implemented by 2023, 2025, or 2026

bottle tracking service

21st Century Cares Act:

when was it passed?

2016

21st Century Cares Act:

allowed for the recruitment of…

more scientists to evaluate products

21st Century Cares Act:

allowed for RMAT which …

approbes biologics