True false General Knowledge Teaching Exams State Level Railways SSC Computer Skill English Speaking

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Question1) How have the 1962 drug amendments affected the profitability of new drugs?


the amendments required generic & patent drugs to be treated the same, so when a new drug got its patent, a generic drug could not compete with it until the patent was expired. this kept prices high because FDA required the generic drug to go thru the same approval process.



Option- ['True', 'False']

Answer: True

Explaination: How have the 1962 drug amendments affected the profitability of new drugs?


the amendments required generic & patent drugs to be treated the same, so when a new drug got its patent, a generic drug could not compete with it until the patent was expired. this kept prices high because FDA required the generic drug to go thru the same approval process.



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Question2) what is the consequence of the FDA providing the public with greater assurance that a new drug is safe?


more strict guidelines to prove the safety which create a drug lag. people have to wait longer for drugs to get them thru the strict approval process. When people have to wait a long time to receive the drugs, then people die waiting for the drugs... also the longer the drug is being developed, the more it may cost because more R&D costs are going into the drug.



Option- ['True', 'False']

Answer: True

Explaination: what is the consequence of the FDA providing the public with greater assurance that a new drug is safe?


more strict guidelines to prove the safety which create a drug lag. people have to wait longer for drugs to get them thru the strict approval process. When people have to wait a long time to receive the drugs, then people die waiting for the drugs... also the longer the drug is being developed, the more it may cost because more R&D costs are going into the drug.



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Question3) why has the FDAs drug approval process sped up in recent years?


it is driven by public policy; more proposals have been made focused on having the FDA rely on evidence from other countries that have high approval standards. this could mean less proof-of-efficacy requirements.




Option- ['True', 'False']

Answer: True

Explaination: why has the FDAs drug approval process sped up in recent years?


it is driven by public policy; more proposals have been made focused on having the FDA rely on evidence from other countries that have high approval standards. this could mean less proof-of-efficacy requirements.




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Question4) what are the advantages & disadvantages of greeter reliance on pre-market testing vs post-market surveillance?


If the approval process is to speed up, greater reliance on pre & post market surveillance will be required. the disadvantage is that more drugs will have adverse side effects & the risks of taking the drug will not be disclosed until the drug has been used by many people. additionally, costs may increase because less drugs are being introduced. there is less competition in the market because the process to approval is very complicated.

advantages? less competition? more merging of drug companies? less small firms because they cannot bear the costs of R&D?



Option- ['True', 'False']

Answer: True

Explaination: what are the advantages & disadvantages of greeter reliance on pre-market testing vs post-market surveillance?


If the approval process is to speed up, greater reliance on pre & post market surveillance will be required. the disadvantage is that more drugs will have adverse side effects & the risks of taking the drug will not be disclosed until the drug has been used by many people. additionally, costs may increase because less drugs are being introduced. there is less competition in the market because the process to approval is very complicated.

advantages? less competition? more merging of drug companies? less small firms because they cannot bear the costs of R&D?



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Question5) what are some criticisms of cross-national studies of drug prices?


they greatly overstate US drug prices because they assume all the purchasers of the prescription drug in the US pay the same price.

-there are large discounts given to certain purchasers of drugs

they exclude generic drugs.

the drug mix consumption in other countries is different than US.



Option- ['True', 'False']

Answer: True

Explaination: what are some criticisms of cross-national studies of drug prices?


they greatly overstate US drug prices because they assume all the purchasers of the prescription drug in the US pay the same price.

-there are large discounts given to certain purchasers of drugs

they exclude generic drugs.

the drug mix consumption in other countries is different than US.



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Question6) although some prescription drugs are priced lower in other countries, is the cost of a drug treatment also lower in those countries?


When using average prices based on the different purchasers, including generic drugs, and weighting drugs by frequency of used to construct a drug price index, the cost of drug therapies in the US may be no higher than other countries.



Option- ['True', 'False']

Answer: True

Explaination: although some prescription drugs are priced lower in other countries, is the cost of a drug treatment also lower in those countries?


When using average prices based on the different purchasers, including generic drugs, and weighting drugs by frequency of used to construct a drug price index, the cost of drug therapies in the US may be no higher than other countries.



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Question7) why would a drug manufacturer be willing to sell a drug that is priced high (in relation to its variable costs) in the US at a low price overseas?


The drug company:

1) has a unique cost structure;

2) there are differences in each country's bargaining power.

Variable costs are relatively low and a drug company is willing to accept any price that exceeds VC; any amount over the VC is revenue.

US consumers are less price sensitive and make more money than people in other countries, so a higher price in US makes sense. If selling overseas at a lower price, as long as the price is above the VC, the drug company is willing to sell it.



Option- ['True', 'False']

Answer: True

Explaination: why would a drug manufacturer be willing to sell a drug that is priced high (in relation to its variable costs) in the US at a low price overseas?


The drug company:

1) has a unique cost structure;

2) there are differences in each country's bargaining power.

Variable costs are relatively low and a drug company is willing to accept any price that exceeds VC; any amount over the VC is revenue.

US consumers are less price sensitive and make more money than people in other countries, so a higher price in US makes sense. If selling overseas at a lower price, as long as the price is above the VC, the drug company is willing to sell it.



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Question8)  what would be the consequences, in terms of drug prices and drug users, if prices of prescription drugs sold in the US had to equal the price at which those same drugs are sold in other countries?


One thing would be higher prices for overseas markets: the drug companies must figure out what price would result in the greatest amount of profit. because the US market has higher prices, the overseas prices would be closer to those higher prices and thus, less people would use the drugs if they had to pay more because price sensitivity. additionally, gov't healthcare means budgets for healthcare, and if they cannot afford the higher price drug, then overseas patients who need the drug will be worse off.



Option- ['True', 'False']

Answer: True

Explaination:  what would be the consequences, in terms of drug prices and drug users, if prices of prescription drugs sold in the US had to equal the price at which those same drugs are sold in other countries?


One thing would be higher prices for overseas markets: the drug companies must figure out what price would result in the greatest amount of profit. because the US market has higher prices, the overseas prices would be closer to those higher prices and thus, less people would use the drugs if they had to pay more because price sensitivity. additionally, gov't healthcare means budgets for healthcare, and if they cannot afford the higher price drug, then overseas patients who need the drug will be worse off.