Generics Vs Brand
Name AED’s
2012
What is a generic?
Generic drugs are copies of brand-name
drugs that have exactly the same dosage,
intended use, effects, side effects, route of
administration, risks, safety, and strength
as the original drug. In other words, their
pharmacological effects are exactly the
same as those of their brand-name
counterparts
Source: Medicinenet.com

So there's no truth in the myths that generic
drugs are manufactured in poorer-quality
facilities or are inferior in quality to brand-name
drugs.
 The FDA applies the same standards for all drug
manufacturing facilities, and many companies
manufacture both brand-name and generic
drugs.
 The FDA estimates that 50% of generic drug
production is by brand-name companies
Generic Vs Brand
Brand Name
Tylenol
Valium
Dilantin
Topamax
Generic
Acetaminophen
Diazepam
Phenytoin
Topirmate
Basic requirements for the approval
of a generic drug
Bioequivalence standard
90% Confidence interval
Single dose studies in healthy volunteers
Typical N 20-30
?
Generic drugs may have different dissolution
characteristics
FDA: true but this is an in vivo test that does
not correlate with performance?
?
Generics drugs are not tested in children
and elderly?
FDA: true, but if it works in adults, it should
work in other populations
?
Generic drugs can be associated with
breakthrough sz and increased side
effects?
FDA: all of the support for this claims arise
from patients and physician reports
(anecdotes or surveys)
?
Brand Med
----0----
85
----0----
100
----0----
125
The Problem
 Professionals
and patient advocacy
groups do not trust generics
 Regulatory
agencies (FDA) consider that
existing rules are adequate.
The Problem
Why are they both wrong?
Neither has provided a scientific proof of its
points
Both sides are susceptible to influence
through “lobbying or political pressures or
financial incentives.
Why are regulatory agencies wrong
Regulatory agencies established universal
bioequivalence rules and never provided
scientific evidence that they are safe for diff
diseases or populations.
Epilepsy is different, if BP goes from 125/85 to
135/95 until next check up the consequences
are negligible.
A sz after a long period of sz freedom may have
mayor consequences
Why are regulatory agencies wrong
The 80% 125% bioequivalence role has real
problems
Generic A 125% x3 months (optimal dose at
1500mg) is getting 2000mg +.
Generic X 80% 1500 x 0.64= 960 mg.
This sudden change by a pharmacist is consider
“Safe lawful and ethical practice”
This same change by a MD would never be
considered safe…
Why are regulatory agencies wrong
Multiple preparations expose the patient to a
large number of excipients or colorants,
increasing the risk of an adverse reaction.
Why are MD and patients advocacy
groups wrong?
The report of patients experiencing significant
problems with the substitution are all anecdotal.
If 1 anecdote has no scientific value 100 or
1.000.000 have no value.
The reporting is heavily biased
Surveys are close to meaningless
Conclusions
-Is there a reason for concern regarding
current generic regulations? YES
-Is the problem with
brand to generic subs; NO/yes
generic to gen YES
-Is the problem exaggerated and are the
opinions biased due to financial interest
YES
How can MD deal with the
dilemma?
-Track what ptes get from the pharmacy, ask
pte to bring the bottle,
-Educate consumers, other MD’s and
pharmacists.
Keep patients on the same formulation, either
Brand or generic (same if possible)
How can MD deal with the
dilemma?
 New
patient, discuss pros and cons.
 Select
ptes that should not be substituted
-Sz free
-Hx of status.