HMGT 3310 NEW FINAL EXAM 100% VERIFIED
main two concerns in regulation of drugs - Answer 1.safety
2. effectiveness
where is most of drug regulation concentrated? - Answer pre-market; there is very little
post market regulation on drugs
importance of IP rights for drug manufacturers? - Answer having a patent provides the
right to the chemical make up of a drug and legal protection for discovery of drug
what are the four pre-market steps someone must go through before getting a drug
approved by the FDA? - Answer 1. file with the Patent and Trademark Office (PTO)
2. Evaluate safety and effectiveness of the drug; apply for approval to move forward in
testing via an Investigational New Drug (IND) exemption
3. Human testing (3 phases)
4. Once human trials are completed must file a New Drug Application (NDA) which is
reviewed by an advisory committee; they make recommendations and give FDA
approval
why must you first file with the PTO? - Answer -to prove intellectual property rights
-has always been common practice, but became mandated under Kefauver-Harris Act in
1962
3 phases of human testing-Answer 1. 20 mo; small subject pool; used to determine if
larger trials would be safe, gauge effects, dosages, and toxicities of the drug; 1/3 of
drugs do not make it past the first phase
2. 30 mo; test on a larger subject pool of people with the targeted condition; focus on if
drug does as indented (effectiveness); 1/3 do not make it past the first phase
3. 31 mo; a LARGE clinical test performed; done in a normal physician's office or clinic;
, only 1/4 of drugs pass this phase
post-market regulations on drugs - Answer -very weak
-doctors are suppose to report adverse side effects however much of this reporting is
voluntarily
-no actual testing to continue to monitor the effects of the drug
cost of drugs - Answer 10% of total healthcare spending
1938 Food, Drug, and Cosmetic act - Answer -written in response to the death of many
children by an antibiotic
-revamped oversight of food and drugs
-established basic regulatory structure of Pharma
-new process to review safety
-FDA extension
Hatch-Waxman Act of 1984 - Answer attempt to bring balance to generic and pioneer
drug firms
-streamlined review process for generic drugs, only made phase 3 required to test
biovariability - generic drug could enter market once pioneer patent ended
-gave pioneer drugs +5 years on patent for time lost to FDA regulation
-the "Orange Book" which is a list of patents available to the public
-FDA responsibility for intellectual property rights
-attempt to merge regulatory functions of safety and economic oversight
agency overview of drugs - Answer -DEA: narcotics, non FDA approved drugs, and
illegal substance; larger budget than FDA
-FDA: regulates over 25% of national economy
-USDA: food supply
main two concerns in regulation of drugs - Answer 1.safety
2. effectiveness
where is most of drug regulation concentrated? - Answer pre-market; there is very little
post market regulation on drugs
importance of IP rights for drug manufacturers? - Answer having a patent provides the
right to the chemical make up of a drug and legal protection for discovery of drug
what are the four pre-market steps someone must go through before getting a drug
approved by the FDA? - Answer 1. file with the Patent and Trademark Office (PTO)
2. Evaluate safety and effectiveness of the drug; apply for approval to move forward in
testing via an Investigational New Drug (IND) exemption
3. Human testing (3 phases)
4. Once human trials are completed must file a New Drug Application (NDA) which is
reviewed by an advisory committee; they make recommendations and give FDA
approval
why must you first file with the PTO? - Answer -to prove intellectual property rights
-has always been common practice, but became mandated under Kefauver-Harris Act in
1962
3 phases of human testing-Answer 1. 20 mo; small subject pool; used to determine if
larger trials would be safe, gauge effects, dosages, and toxicities of the drug; 1/3 of
drugs do not make it past the first phase
2. 30 mo; test on a larger subject pool of people with the targeted condition; focus on if
drug does as indented (effectiveness); 1/3 do not make it past the first phase
3. 31 mo; a LARGE clinical test performed; done in a normal physician's office or clinic;
, only 1/4 of drugs pass this phase
post-market regulations on drugs - Answer -very weak
-doctors are suppose to report adverse side effects however much of this reporting is
voluntarily
-no actual testing to continue to monitor the effects of the drug
cost of drugs - Answer 10% of total healthcare spending
1938 Food, Drug, and Cosmetic act - Answer -written in response to the death of many
children by an antibiotic
-revamped oversight of food and drugs
-established basic regulatory structure of Pharma
-new process to review safety
-FDA extension
Hatch-Waxman Act of 1984 - Answer attempt to bring balance to generic and pioneer
drug firms
-streamlined review process for generic drugs, only made phase 3 required to test
biovariability - generic drug could enter market once pioneer patent ended
-gave pioneer drugs +5 years on patent for time lost to FDA regulation
-the "Orange Book" which is a list of patents available to the public
-FDA responsibility for intellectual property rights
-attempt to merge regulatory functions of safety and economic oversight
agency overview of drugs - Answer -DEA: narcotics, non FDA approved drugs, and
illegal substance; larger budget than FDA
-FDA: regulates over 25% of national economy
-USDA: food supply
