Lecture 4 part 3 Flashcards
Generic Drug Enforcement Act of 1992
Authorized FDA to ban anyone from drug approval process if convicted of related ________
Imposed severe penalties for any false statements, bribes, failures to disclose material facts or other related offenses involved the FDA.
felonies
Prescription Drug User Fee Act of 1992 in response to the cost of getting a drug through the whole drug approval process all the research and development you have to do the prices kept going up and up…today its 3 billion dollars for one drug and it was taking long…it was taking 9 to 10 years to get a drug approved from its initial discovery…while those 9 to 10 years are going on that’s the time of your patent so if you had a 20 year patent term and it takes you 9 years to get it approved you already lost 9 years of elusive manufacturing you only have a little left which means you have to charge a higher price to recuperate billions you spent doing the research in other words you have less time where you’re the elusive manufacturer…it established supplemental fees to the FDA that were charged with any new drug application…when they file new drug application depending on company size and what the drug is there are additional fees and these are MILLION dollar fees!
Prescription Drug User Fee Act
Established ______ to be submitted to the FDA with all NDAs applicable to all drug manufacturers with the exception of orphan drugs and small manufacturers
Provided that the fees could only be used by Congress to supplement the FDA’s existing budget. Therefore the fees could be used to increase the FDA’s NDA review capabilities
With Prescription Drug User Fee Act
Manufacturers will bare some of the responsibility…so they pay a tax whenever they file a new drug application and congress has no say over that money..that money is not considered part of the FDA budget that they get through Congress…in other words congress can’t adjust their budget…oh we know your going to get 100 million dollars through that so we are going to decreased your budget…congress can’t do that…put an additional burden on manufactuerers…only impacts on BRAND NAME MANUFACTURERS
(((The standard review time for drugs is 7 years because FDA could hire additional reviewers with the additional money they had )
Prescription Drug User Fee Act
Sunsetting of a law…many laws when they are passed by congress they put a limit on them how long they are good for and the typical standard is 5 years…not all laws have a sunset provision and the prescription drug user fee act does have a sunset…every 5 yrs congress has to basically put this in as an amendment to another law so it gets passed again or otherwise its gone…if its not passed again it ends
Dietary Supplement Health and Education Act of 1994 in response to there was drugs or foods…couldn’t put a drug in a food…now they came up with dietary supplements…all vitamins are dietary supplements
Dietary Supplement Health and Education Act of 1994
Defined __________as a new entity neither drug nor food.
Allows D.S. manufacturers to make 4 types of substantiated claims, if they notify FDA of their intent to do so within 30 days:
A.Statements that the product will benefit a nutritional __________, if state the prevalence of the deficiency in the U.S.
B. that describe the role of the D.S. plays in a body structure or function (ex:calcium can help build strong bones)
C. that characterize the ways in which the D.S. acts in maintaining the body’s structure or function
D.describing the general ____________that may be achieved using the D.S. (ex:Good intestinal health or good nutritional health with a fiber product)
deficiency
well-being
Melatonin is a dietary supplement and NOT a drug
Dietary supplements there is no preapproval required
Dietary supplements CAN’T make disease specific claims!!
Dietary Supplement Health and Education Act of 1994
Statements (continued): If you do make claims, must place on label: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease
Health Insurance Portability &
Accountability Act (HIPAA) of 1996
Regulations went into effect 4/14/2003:
All pharmacies must institute _______policies w/
a privacy officer
Customers must be offered the notice of privacy
practices (“NoPP”) on their first visit, and be
asked to sign an acknowledgement. Provider
must publish NoPP and make it available.
Must keep all records ____________.
Must provide ___________ counseling area.
privacy
confidential
private
The Food and Drug Administration
Modernization Act (FDAMA) of 1997
Renewed Prescription Drug User Fee Act for
another 5 more years.
Motivate drug manufacturers to perform
___________studies by extending license
exclusivity by 6 months.
Established a _________ drug review process
to which manufacturers could apply for
innovative drugs needed for lifethreatening diseases.
fast track
pediatric
Supplemental NDA…we have an already approved drug and its on the market but now we have a new indication for it and we have done the research and shown that it works…its effective for that and we want to get that approved and what happens is when you do that…when you do a supplemental NDA you don’t have to do the safety stuff again unless you change the dose dramatically or the way its implied or used but you basically just have to show the effectiveness because the safety has already been shown… the fda modernization act tried to make process as short as possible but it still cover safety and efficacy….required fda to establish scientific advisory panels (consists only of practitioners and scientists and NOT FDA agents)
The FDA Modernization Act of 1997
Streamlined the process by which a
manufacturer gains approval for a new
process for an approved drug, and when a
____________ is required.
Streamlined the _________required in an
NDA.
Required FDA to establish scientific
advisory panels and to provide guidelines
as to their operation (these are nonfda agents)
supplemental NDA
clinical data
