Lecture 1-2 Flashcards
Zepbound vs mojourno
Mojourno is used for weight loss
we have Zepbound now released as new weight loss drug, so new terms of the step therapy and PA and BMI is created
30 – 40 yrs later we have zepbound
Eli Lily
Created prozac a blockbuster drug and it is the earliest being sold. Years later, sarafem was made for PMDD.
period changes ,PMDD (premenstrual dysphoric disorder). Eli Lilly had it as off-label PMDD, today this is illegal
When running trials for prozac, they discovered new indications and marketed it as sarafem. Eli Lilly went from a nda to a snda.
Eli Lilly did “medicalization”: new medical conditions and gave a new name and called it a disease and developed a product for it and started marketing for it.
Types for applications of fda review:
1.Safety :LEGALLY/ mandatory required for marketing in FDA
2. Efficacy :(LEGALLY/ mandatory required for marketing in FDA)
3. Quality - not legally required
4. Economics - not legally required
IND: (first paperwork) investigation of new drug app. Filed with fda, POST animal studies, or preclinical studies (ANIMALS)-250 animals. We can test for safety on animals not really on efficacy because humans have different conditions than animals.
NDA:
SNDA: adds a new indication (eli lilly turns prozac into sarafem)
PHASES 1-3
Phase 2 and 3 - tested for efficacy need disease population not on healthy patients.
New indications and use of drug is discovered
Phase 3- is longer and more people
3 phases are in total 7 years
NDA- FDA has 6 months to 1 year (180 days) act on it and approve it. Then we have phase 4, and then SNDA it is an extended or supplement NDA.
cost of drug development
2-3 billion
Phase IV:
is post marketing surveillance (MANDATORY), access long term safety
Program for phase 4 - called med watch (it is voluntary and not for manufacturers, it is run by FDA)
Med watch- medical product safety reporting for health professionals, patients and consumers. This is not RTC, it is real world trail
RTC- phase 1,2,3. These are lab run and experimental in nature.
Off label
doctors cannot promote it for that use
Obesity
is according to BMI
FDA resources
CDER, center for drug evaluation and research
What does fda regulate?
-foods (dietary supplements, or nutraceuticals), drugs, biologics, med device, electronic, cosmetic, tobacco
Dietary supplements and nutraceuticals
no FDA approval process, they do not need RTC (randomized controlled trial)
Medwatch
adverse events reporting, run by FDA (not drug company), and covers the quality (not mandatorily). These regulate prescription, otc, biologics, cosmetics, nutritional, food, med dev. Medwatch is voluntary and not required.
Merck- medwatch helped to see vioxx was not good and ADRs
Who submits the most on medwatch?
pharmacists
ISMP
- private not federal (safety of meds)
- med errors
DRUG database
Orange book( generic substitution manual or bible) - generic drug products, mostly used by the pharmacist
-Purple book- biologics
-national drug code directory
Drugs @FDA
biological products and drugs, does not include info on FDA products, its regulated by CBER. include most recent labeling by the FDA It is used by consumers, mostly.
