Drug Regulation Flashcards
What is the role of the federal government in drug regulation?
FDA
1. determines WHAT must be PRESCRIBED (Rx)
vs.
sold directly to the public (OTC)
- Evaluates new drugs for safety and efficacy (removes unsafe dietary supplements)
- Evaluates equivalency of name brand v. generic products
What is the role of the state government in drug reglation?
controls WHO may prescribe
(in the form of state medical boards)
EXCEPT in the case of controlled substances:
DEA (rep. Dept of justice)
What organization controls licensing for the prescription of controlled substances?
Department of Justice -> via DEA licensing
What is the role of local government in drug regulation?
can pass laws regarding drug us in their jurisdiction
In general, what law applies when regulations or laws differ?
it is assumed that the strictest law will apply
ex) an MD with a controlled substance license risks loosing it if he/she chooses to prescribe medical marijuana
What must a manufacturer demonstrate prior to marketing a new drug?
Proof of efficacy and safety
What is an important effect of the DSHEA (Dietary Supplement Health & Education Act) of 1994?
Allows sale of dietary supplement to the public without prior evidence of safety or efficacy
must contain disclaimer:
“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.”
What types of substances are considered dietary supplements?
vitamins
minerals
amino acids
herbs -> BLACK BOX!!
What is the first stage of testing for a new drug?
Animal studies
What is the purpose of animal studies?
- study pharmacology, drug metabolism, toxicity (acute and chronic)
- Attempt to determine safe human dosing range
3.
How long do animal studies last, and what do they cost?
5-8yrs
$30-60 million
What is an IND application?
Investigational New Drug application
- requests permission from FDA to being clinical testing in humans
What is the purpose of Phase I clinical testing?
Cost?
Is it safe?
- less than 1 yr long
- <100 healthy males 18-45y/o, volunteers
- *determine if animal and human responses differ significantly**
- $100-200 million
What is the purpose of Phase II clinical testing?
How long does it last?
Does it work in patients?
- 200-300 patients (ideally w/o other medical problems)
- compared to placebo or existing drug
- more safety. efficacy -> may detect new range of toxicities
- dosing regimen determined
- 2yrs long
75% of drugs fail in phase II testing
What is the purpose of Phase III clinical testing?
How long does it last?
Does it work, double blind?
- 1000-6000 patients in realistic setting
- efficacy against established therapy
- monitor effect of chronic use
- 3 yrs
When can a NDA be submitted?
a New Drug Application can be submitted if there are positive results after Phase III is unmasked
- for a specific use of drug
Can FDA regulate off-label use?
No
- but important to consider if there are state board/ institutional regulations
What is an ANDA and when can it be used?
Abbreviated New Drug Application
- for approval of generic drugs
- bypasses clinical trial
- only required to meet bioequivalence standards
When might a drug receive accelerated conditional approval? What is required?
treatment of serious life-threatening conditions (cancer, AIDS)
- more definitive clinical trials must be conducted after the initial approval
What is phase IV of clinical testing?
manufacturer required to submit adverse effects of drug once on market
- patients and providers asked to contribute
low incidence side effects will be missed in phase II and III trials
180,000 required to detect 1/10,000 effect
18,000 required to detect 1/,1000 effect
1,800 required to detect 1/100 effect
What is pharmaceutical equivalence?
same ACTIVE INGREDIENT => same pharmacologic effect
same DOSAGE FORMULATION (capsule tablet, etc)
same ROUTE OF ADMINISTRATION
identical STRENGHT OR CONCENTRATION
What is a pharmaceutical alternative?
same MOIETY (proportional part)
different SALT, ESTER, OR COMPLX of moiety
different DOSAGE FORM
**Immediate Release is NOT Extended Release
What is a bioequivalent?
display COMPARABLE BIOAVAILABILITY under similar conditions
measured by
RATE of absorption: estimated by Cp max
EXTENT of absorption: measured by AUC
generics must be within 4% of name brand
What is a therapeutic equivalent?
Provide same SAFETY & EFFICACY when delivered to SAME INDIVIDUAL in the SAME DOSAGE
Code A to generics considered therapeutically equivalent
Code B to generics not considered therapeutically equivalent
**once bioequivalency is demonstrated->
therapeutic equivalency is ASSUMED **
