Lecture 4 part 2

Question 1

Federal Anti-Tampering act of 1982

in response to Chicago in 1982 there were 7 deaths of random people after taking Tylenol. Tylenol had been laced with cyanide

Question 2

Federal Anti-Tampering Act of 1982

-Requires certain (not all) OTC drugs and devices to manufactured in _______(NOT tamper-proof) packaging, or it will be considered misbranded and/or adulterated by the FDA

Answer 2

tamper-resistant

Question 3

Orphan Drug Act of 1983 in response to a virus called HIV which can result in AIDs

Question 4

Orphan Drug Act

Provides tax and exclusive licensing _________to manufacturers to develop and produce drugs intended for diseased populations of <200,000 people within the U.S.

gave an extension on patent and other incentives for drug manufacturers to do research on drugs for HIV

Answer 4

incentives

Question 5

Drug Price Competition and Patent Term Restoration Act (Wxman-Hatch Amendment of 1984)

In response to Generic Drug manufacturers came into being in the late 1970s and 1980s…brand companies like lil had a whole line of products including what we known as generic but that word wasn’t used back then…they would give each of their generics their own brand name…companies produced generic drugs and sell them under generic name…

the brand name manufacturer tried to stop them from doing this because they were losing market share…because they would sell them cheaper.. made a law saying all generic is the same as the brand name product…gave manufacturers 3 more years on their patent drugs…gave to both parties something

Question 6

Drug Price Competition and Patient Term Restoration Act

showed our generic is the same as the brand name product and did alot of pharmaceutical research to prove their product is the same as the brand name product so it doesn’t cost them a billion dollars and thats all the generic company has to do…doesn’t have to go through drug process all over again

Question 7

Drug Price Competition and Patent-Term Restoration Act (Waxman Hatch Amendment)

Made into law the Abbreviated New Drug Application (“_________) process for generic drug manufacturers

Extended the term of _______from 17 years to 20 years for the manufacture of brand name pharmaceuticals

Answer 7

ANDA

Question 8

All patents now are 20 years

Question 9

Prescription Drug Marketing Act in response to doctors,physicians… manufacturers use to provide doctors free samples to give to their patients …corrupt person said maybe we could buy those samples that the doctors got for free and give them money and we will turn them around and repackage them and resell them to pharmacies and we all make money because we can end up selling it for less to the pharmacies than what they are paying for…so sent offshore to the Bahamas and then did repackaging and came back to the US…this law made it so states must license drug wholesalers…reimportation of drugs is banned, unless is emergency or is performed by manufacturer OF THE PRODUCT ONLY

Question 10

Prescription Drug Marketing Act

States must license _________

Reimportation of drugs is banned, unless is emergency or is performed by manufacturer

Banned the sale,trade or purchase of drug samples

Mandated storage, handling, and record keeping requirements for drug samples

Answer 10

wholesalers

drug samples

Question 11

With coupons billing to third party and manufacturer is paying for it.

Question 12

Can you have prescription drug samples in a massachusetts pharmacy? NO!

Question 13

Prescription Drug Marketing Act of 1987

Banned the trafficking in or counterfeiting of ________

Prohibited the resale of prescription drugs purchased by nonprofit hospitals or health care facilities with only a few exceptions:returns to drug wholesalers or drug manufacturers

Answer 13

drug coupons

Question 14

Omnibus Budget Reconciliation Act of 1990

Pharmacists (or their agents) must offer to counsel all __________-patients on every new or refiled prescription

States must establish ___________________(“DUR”) programs for Medicaid

Answer 14

Medicaid

Drug Utilization Review

Question 15

On all medication prescription new ones or refills pharmacist must offer to counsel on medicaid patients based on the Omnibus Budget Reconciliation Act

Question 16

Nutrition Labeling and Education Act of 1990 in response to a lot of foods were beginning to make all sorts of claims regarding their products…drugs were being put in foods so that was the concern…every food has to have a nutrition label and this is the law that created that label and mandated it…nutrition label that’s on every food product now it tells you how many calories are in it and how much fiber is in it and carbohydrates and proteins…this is the law that created that label and mandated it

Question 17

Nutrition Labeling and Education Act of 1990

Authorized the FDA to establish standardized nutritional labeling, and requirements to make health claims regarding food products

Answer 17

nutritional labeling

Question 18

Safe Medical Devices Act of 1990
Strengthened Medical Amendment of 1976:
Expedited ___________device approval process

Additional authority over: Premarket notification and approval

Postmarketing requirments

Answer 18

premarket

Question 19

Generic Drug Enforcement Act of 1992

in response to FDA officials caught taking bribes from drug manufacturers to push my drug along the approval process faster…this law it authorized the FDA to ban anyone from any drug approval process if they are convicted to some sort of related felon..did not go after fda agents who the bribe but went after the people who gave them bribes…so the people who gave them bribes they got prosecuted and now they said you can’t have anything to do with any drug approval process at all anymore…if someone gets convicted of anything involved the FDA your outside the FDA your not in it you can no longer be involved with anything the FDA has anything to do with