Law Exam 1 - Lecture 7 (supply chain, advertising, and HIPAA) Flashcards
OTC, control or not and what schedule, route of admin, any special packaging
- for the drug list
1987: prescription drug marketing act 4 main aspects
- reimportation
- preferential pricing
- samples and coupons
- wholesale licensure
PDMA - reimportation
a drug cannot be reimported into the US unless reimported by the manufacturer or for emergency use after FDA review
-bans importation of american-made drugs from foreign countries, NOT importation of drugs from a foreign country
PDMA - preferential pricing
bans the sale, purchase or trade of a prescription drug purchased at a reduced price by a hospital or other healthcare facility or donated or supplied to a charity
PDMA - samples and coupons
bans the sale, purchase or trade of a drug sample or drug coupon, and bans counterfeiting of drug coupons
PDMA - wholesale licensure and more
-states were required to license wholesalers
-records related to PDMA must be maintained for at least 3 years
-whistleblower awards up to $125,000 for reporting
Drug Supply Chain Security Act (DSCSA)
-includes: manufacturers, repackagers, wholesalers, distributor, and dispenser
National Drug Code (NDC)
11 numbers (55555-4444-22)
first 5 numbers of NDC
-identify the manufacturer
-assigned by FDA
middle 4 numbers of NDC
-identify the drug, strength, dosage form, and formulation of the product
-assigned by the manufacturer
last 2 numbers of NDC
-identify package size
-assigned by manufacturer
Drug advertising and promotion
-FDA vs. FTC
-the FDA regulates prescription drug advertising
-the Federal Trade Commission (FTC) regulates nonprescription drug advertising
Advertising to professionals
-advertising must include what 5 things?
- established name of the drug
- formula of the drug
- adverse event information
- contradictions
- effectiveness
advertising to consumers (DTC) 5 standards to comply by
- Presented in consumer-friendly language
- Presented with appropriate audio (understandable with good pacing)
- In TV ads, presented using audio and text
- In TV ads, text must be easily readable
- free of audio or visual elements that might interfere with the comprehension of the major statement
Off label advertising
-off label use
an indication other than that approved by the FDA, and thus not included in the approved drug labeling
-must be complete, peer review, journal article
Off label advertising
-to disseminate these Journal articles, the company must have 3 things
- have applied for aproval for tha indication
- submit a copy of the information and any clinical trial data the company has at least 60 days before disseminating
- include these documents:
a. disclosure noting it has not been approved
b. a copy of the official label for the product
c. any other products that have been approved for off-label use
d. the funding source for the studies relating to use
e. a bibliography of publications relating to use
HIPAA (1996) applies to what 3 groups (covered entities)?
- Health care providers
- Health plans
- Health care clearing houses
4 key pieces in HIPAA
- privacy rule
- security rule
- breach notification rule
- enforcement rule
- privacy rule
-includes:
PHI
-MRN
-SSN
-pt name and DOB
-pts medical conditions (past present or future)
-payment of medical care
*de-identified health info is not PHI
- privacy rule
-permitted uses and disclosures
- security rule
requires covered entities to maintain reasonable and appropriate administrative, technical, and physical safeguards of electronic PHI
- breach notification rule
if a covered entity discovers a breach of unsecured PHI, it is obligated to report that breach
- breach notification rule
-specifics of >500 vs <500 people
