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Problems with How Generics are Ap

Posted 11-27-19 at 09:10 PM by wonderboy
1. When a generic firm resolves to submit a application for a generic medication, it is the firm, not the FDA, that conducts clinical tests to confirm that their product is bioequivalent
to the brand name drug.


PROBLEM #1: POOR EXTERNAL AND
INTERNAL VALIDITY


External validity is the degree to which findings from research, tests, and statistical analysis can be accepted as reliable to a broad array of the population.


It should include, for example, geriatric subjects, individuals with renal compromise, or liver compromise etc.....


Many times, this is not the case at all…


Concurrently, solid external validity requires a rather -large- sample when conducting both testing and statistical analysis.


Many times, generic firms (conducting their clinical tests) may have as few is 12 to 15 subjects.


____________________________________
*** I have read about firms, who in this process, have not even included a patient over the age of 65.
___________________________________



PROBLEM #2: The generic firm’s results are not made public, and we (the consumers) must trust the inherent veracity of the firm’s results, and their “specific approach” of their testing, that it was indeed completed in a clinically appropriate way, with proper and appropriate external and internal validity.


They (the generic firm) submit their results, confidentially, to FDA, yet the FDA is not “necessarily” always “on site” to oversee the firm as they conduct all their testing, and specifically, their final statistical analysis concerning their drug’s efficacy.



PROBLEM #3 Once the generic firm
receives FDA approval for their ANDA, production and manufacturing of the drug is -invariably- produced in Third World countries.


Although this obviously is not always the case,
you might be shocked at where some firms produce products.


The FDA simply does not have the time, resources, and manpower to oversee every generic firm’s
manufacturing plants (and most importantly)
their specific quality control procedures and standards.


Moreover, you would be poignantly naïve to think that the FDA isn’t corrupt... to some degree…..



PROBLEM #4: Bioequivalent Standards


Bioequivalent means that the drug is considered statistically similar, in every conceivable way, to the brand-name drug. The “fillers” (the non-active drug) fillers may, of course, vary.


Although it is true that the FDA is cracking down on this issue, especially considering the generic Wellbutrin problem several years ago,
a generic drug can be plus or + or - 20% Bioequivalent to that of the brand name.


The claim is: that this variation is not “statistically significant”

I will let you be the judge and jury on that statement


For more information on this, review the
Hatch-Waxman Act of 1984


This is why a kaleidoscope of people comment on the marked differences of generic Adderall brands
on this form, which seems to me to be one of the most discussed topics here.


I sincerely appreciate you taking the time to read this, and I look forward to any commentary
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