Final Study Guide: Drug Development and OTC's Flashcards
Why was the Pure Food and Drug act put into place in 1906 and what did it accomplish?
- To deal with addiction problem of popular drugs.
- It required manufacturers to list ingredients
Why was the Modified Food, Drug and Cosmetic Act put into place in 1938 and what did it accomplish?
- Mass poisoning of individuals taking sulfa drugs containing Diethylene Glycol.
- Drugs must be demonstrated safe
What was the Durham-Humphrey Amendment and what did it accomplish?
- There were many new drugs including OTC’s.
- It made the distinction between OTC’s and Rx.
What were the reasons set forth at the time of the Durham-Humphrey amendment for prescription drugs?
1) Addiction
2) Toxicity
3) Serious Disease
What was the Kefauver-Harris amendment for, and what did it accomplish?
- Thalidomide was causing Phocomelia (Flipper Limbs)
- It established that EFFICACY and Safety are musts
What are some important things that the FDA regulates?
- Foods (Dietary Supplements)
- Drugs
- Tobacco Products
What are the stages of Pre-clinical Research and Development?
1) Initial Synthesis
2) In Vitro Testing
3) Animal Testing
What are the goals of initial synthesis?
Solubility
Specificity
Toxicity
*they make hundreds of thousands of variants of the drug during this process.
What is needed before Animal Testing can begin?
IACUC approval
*Institutional Animal Care and Use Committee
What are the animals generally used in animal testing and what are they trying to measure?
- 2-3 species of rat or mouse
- Side effects and dose
After the stages of testing are complete, what is the next step in development?
- Make an Investigational New Drug Designation (IND)
* Essential first communication with the FDA
If the FDA gives the go ahead after IND, how many phases of clinical testing must then take place?
3
Phases I, II, and III
What happens during Phase I clinical testing?
- Group of small # of healthy volunteers
- Non-blind study
- 70% of drugs don’t pass this phase
Goal= establish safety, learn about dose, report data to FDA
What happens during Phase II of clinical testing?
- Clinical Pharmacology Phase
- Double-blind study w/ Placebo controls
- Small Group of individuals with illness
- 30% Pass to phase III
Goal = Efficacy and safety
What happens during Phase III of clinical testing?
- Extended Clinical Phase
- Thousands of individuals
- Double-blind study w/ Placebo controls
If a drug passes all of the clinical phases what is the next step?
New Drug Application (NDA)
What is done after the NDA and is many times considered “Phase 4”?
Marketing
*includes a period of continued assessment for Side Effects
What are possible exceptions to the full length development process?
-Fast-track: Streamline a drug that is needed for urgent situations.
- Orphan Drug Act: Drugs for Rare conditions
- Tax Breaks
- Longer patents
As far as exclusive rights are concerned, what does Proprietary mean?
The Company that owns the patent.
They are the only ones that can make the drug.
As far as exclusive rights are concerned, what does Generic mean?
Market for the Patent
Anyone approved can make the drug
As far as exclusive rights are concerned, what does Generic Substitution mean?
“Dispense as Written”
The formulation may be slightly off in a substitute, though most are very close.
When were there first committees to regulate OTC’s?
1970’s
What is the definition of a Category I OTC?
- Safe and effective for indicated purpose
* most OTC’s
What is the definition of a Category II OTC?
-Not Safe and/or Not Effective
or
-Inappropriate Indication
