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Generic Drugs: Robert L. West Deputy Director Office of Generic Drugs

Generic drugs are safe and effective alternatives to brand name drugs that have led to significant savings for consumers and the healthcare system. To gain FDA approval, generic drugs must demonstrate bioequivalence to the brand name drug by containing the same active ingredients and delivering them to the body in the same amount and time. Recent studies have found generic drugs to be highly equivalent to their brand counterparts, with actual differences in active ingredients well within the narrow statistical ranges required by the FDA for approval. This allows generic drugs to offer the same clinical benefits as brands at a much lower cost due to avoiding expensive development and marketing costs.

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120 views16 pages

Generic Drugs: Robert L. West Deputy Director Office of Generic Drugs

Generic drugs are safe and effective alternatives to brand name drugs that have led to significant savings for consumers and the healthcare system. To gain FDA approval, generic drugs must demonstrate bioequivalence to the brand name drug by containing the same active ingredients and delivering them to the body in the same amount and time. Recent studies have found generic drugs to be highly equivalent to their brand counterparts, with actual differences in active ingredients well within the narrow statistical ranges required by the FDA for approval. This allows generic drugs to offer the same clinical benefits as brands at a much lower cost due to avoiding expensive development and marketing costs.

Uploaded by

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We take content rights seriously. If you suspect this is your content, claim it here.
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Generic Drugs

Robert L. West
Deputy Director
Office of Generic Drugs
1

OGD Mission:
To ensure through a scientific and
regulatory process, that generic
drugs are safe and effective for
the American public.

Did you know that generic drugs...


Are safe and effective alternatives to brand name
drugs
Reduce the cost of prescription drugs for both
consumers and the government
Represent 70% of the total prescriptions dispensed
in the US
Saved American consumers $824 billion in the last
decade
Save approximately $53 for every prescription sold
3

Also
Each year, more than 2.6 billion
prescriptions are filled in the U.S. using
generic drugs.
Compare that amount to approximately
1.2 billion brand-name prescriptions
dispensed each year.

In order to receive FDA approval, generic drugs


must:
contain the same active ingredient
be the same strength
be the same dosage form (tablet, capsule, etc.),
and
have the same route of administration (oral,
topical, injectable, etc.) as the brand name
drug.
5

Other Requirements

In addition to being pharmaceutically equivalent, generic drugs


must also be bioequivalent to the brand name drug.

That means the generic drug will work in the body in the same
way (same amount goes into the body within the same time
frame) and be as safe and effective as the brand name drug.

These studies are the same studies brand manufacturers conduct


when they make changes in their product after approval.

Generic Drugs are Equivalent


Recent study to evaluate bioequivalence of generic
drugs approved within a 12 year period when
compared to the brand products.
2070 bioequivalence studies
Mean standard deviation 1.00 0.06 for Cmax (peak
level) and 1.00 0.04 for AUC (amount absorbed)
(Annals of Pharmacotherapy October, 2009)
7

In another analysis of hundreds of


bioequivalence studies:
The measured differences between
brand and generic drugs are the same
as the differences between different
lots of the SAME branded drugs.

Misinformation
There is a frequent misinterpretation of
the bioequivalence of generic drugs.
The assertion that levels of the active
ingredient in generic drugs may vary
from minus 20% to plus 25% compared
to the brand.
THIS IS NOT TRUE!
9

Statistics Involved
Those numbers relate to the complex
statistical calculation used to analyze
bioequivalence studies.
They do not represent the actual
difference in the amount of active
ingredient a patients bloodstream.
Actual differences are the numbers
found in the recent studies.

10

Brand Name Drug vs. Generic Drug Review Process


Brand Name Requirements

Generic Requirements

1.
2.
3.
4.
5.
6.
7.
8.

1.
2.
3.
4.
5.

Chemistry
Manufacturing
Testing
Labeling
Inspections
Animal Studies
Clinical Studies
Bioavailability

Chemistry
Manufacturing
Testing
Labeling
Inspections

6. Bioequivalence
11

Only Differences
Development of the active ingredient
Pre-clinical animal studies for safety and
efficacy
Human clinical trials to prove the efficacy
and safety of the active ingredient

12

Result
Generic drugs are less expensive because
it isnt necessary to repeat:
Discovery
Pre-clinical studies
Clinical studies (repeating would be unethical)

Generic firms generally dont do


advertising and promotion.
13

When will FDA approve a generic for


the medication I am taking?
FDA generally approves a generic drug on
the first day it legally can do so.
Consumers have timely access to high
quality generic drug products.

14

OGD Website

15

Questions???
Contact OGD:
E-mail: [email protected]

16

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