Drug Development FINAL Flashcards
What was the reason for the Pure food and drug act?
-Deal with addiction caused by opioids and cocaine.
What does the pure food and drug act require?
-Labeling ingredients for patent medicines (“secret ingredients”)
What was the reason for the Modified food drug and cosmetic act?
-antibiotics (sulfa drugs) were not soluble so they put in diethylenegylocol that killed a lot of individuals
What did the modified food drug and cosmetic act require?
-The drug must be safe (didn’t say that it had to be effective)
What was the Durham-Humphrey Amendment?
- Makes the distinction of Rx vs OTC
- Looked at the addiction potential
- Looked at the toxicity
- What is the indication (self limiting vs non self limiting)
What is the reason for the Kefauver-Harris Amendment?
-Thalidomide would cause phocomelia
What did the Kefauver-Harris amendment require?
-Safety and efficacy
What does the FDA regulate?
- Food
- Dietary supplements
- Bottled water
- Food additives
- Drugs
- Biologics
- Medical devices
- Cosmetics
- Veterinary products
- Tobacco products
- Advertising of products
- Oversee the testing of the drugs
What does the Dietary supplement health and education act regulate?
- Herbal products
- Defines herbal products as foods
How much money does it cost to develop a drug?
-1-2 billion
Animal preclinical testing is controlled by what?
-Institutional animal care and use committee (IACUC)
What are the 2 species of animals that are tested?
- Rodent
- Depends on what you are looking at testing (pigs and hearts)
What is an IND?
- Investigation new drug
- notice that a new drug will be submitted for FDA consideration
What is phase I?
- Small group of healthy (usually) subjects to test safety, doses, administration and other kinetics
- Initial clinical phase
What is phase II?
- Small group of subjects with condition to be treated to test safety (still) and efficacy
- clinical pharmacological phase
What is phase III?
- Extended clinical phase
- Large group of subjects, using double blind construct, placebos and multi-sites groups to test for statistical efficacy
What is phase IV?
-Marketing and see how the product does in production
What has to happen before a drug can go in to clinical trials?
- FDA approval
- IRB approval
What is IRB?
- Institutional review board
- review of proposal for human testing
What is the fast track drug?
- Streamline process for urgent situation
- Qualify for special consideration in FDA-directed process that speeds up the evaluation step and extends the patent for life
What is the Orphan drug act?
- For rare disease to encourage drug development (less than 200,000)
- Gives you increased patent life
- Tax incentives
What is proprietary?
-Name brand
What is generic?
-After patent expires
What does DAW mean on a prescription?
-Dispense As Written
What is non-prescription drug category one?
- Safe and effective for indication
- Most OTCs
What is non-prescription drug category two?
- Unsafe or ineffective
- improper indication
- Not OTC
What is non-prescription drug category III?
- Not sure
- Requires more studies
New drugs are always made prescription for at least how many years before considering their conversion to OTC status?
-3 years
What is the switching policy?
-Goes from Rx to OTC
Before you can switch from Rx to OTC status what has to happen?
- be a prescription for at least 3 years
- Good safety record
- Widely available
- used frequently to demonstrate a need
- based on the need to reduce cost
What is an NDA?
- New drug application
- the final FDA step of approval/rejection after evaluating all the studies and data from testing phases
what is FTC?
- federal trade commission
- control labelling
- products in this category cannot be promoted to diagnose, treat, or prevent disease
T or F:
the FDA monitors and performs tests on products
- false
- they oversee testing, but do not perform the tests
what 3 things determine the distinction between prescription and OTC drugs?
- addiction/abuse liability
- relative safety
- intent of use - does it require professional input/control?
