Introduction + FDA Flashcards
scientific definition of drug
external molecules interact with internal molecules that lead to biochemical changes
federal definition of drug
“articles” (instead of molecules) used for treatment / prevention of disease and are intended to affect body or animals
CDER
evaluation and research of drugs
responsibilities of CDER
testing for drug safety and efficacy
quality control for drug manufacturing
oversight of drug marketing and advertising
post-approval surveillance of drugs on the market
dietary supplements are regulated as ____ by _____
food products
CFSAN
what does dietary supplements being regulated as food mean?
-less stringent manufacturing guidelines
-no pre-approval safety testing
-no need for efficacy testing
like drugs, dietary supplements can
have therapeutic benefits
be toxic
produce unwanted interactions
1906 pure food and drug act
standards for drug strength and purity
1938: food, drug, and cosmetic act
prompted by elixir sulfanilamide tragedy (diethylene glycol - kidney failure)
mandated safety testing
1962: amendment of food, drug, and cosmetic act
stronger safety standards and efficacy testing
prompted by thalidomide disaster (birth defects)
2007: FDA amendements act
prompted by COX-2 inhibitor heart problems
more FDA control over approved drugs
blockbster drugs
account for most drug revenue (fuels rest of company costs)
first in class medications
does things that no other drug does (innovative but expensive)
me too medications
modified versions, cheaper to make, creates competition so it lowers drug costs
orphan drugs
pharm agent developed to treat medical conditions, which because they are so rare, wouldn’t be profitable to produce without government assistance
double blind design (phase III clinical trials)
no one knows the treatment condition, removes bias
placebo control
comparison permits examination of natural course of disease without drug
placebo effect
patients respond to placebo 10-20% of time
MedWatch
post marketing surveillance of drug safety
can lead to meds being withdrawn from market
changes in use parameters
recalls or altered labeling
black box warning
FDA required label that prescription drugs carry significant risk of serious / life threatening effect
off label use
FDA approves for specific condition - anything other than normal usage is considered off label
providers can prescribe drugs outside marketed indications
no pharmaceutical company marketing allowed
category A (pregnancy)
pregnant women show no increased risk in fetal abnormalities
category X (teratogen)
pregnant women demonstrated evidence of fetal abnormalities
teratogen
substances that harm a developing fetus / embryo
