Concerning Issues Regarding Generic Approval

Two profoundly concerning issues with respect to generic companies receiving approval for their product


1) What is even more interesting (and, in my opinion, both unacceptable and unethical) is the "testing process" which a generic company completes in order to complete the application (an ANDA) to the FDA, for ultimate approval. Here is what I mean:

1) The generic company --alone-- performs all the tests to ensure it is commensurate with the Brand

.---This information is -------confidential------, the results are not available to the public.

One only can speculate what the: (is)

A. Internal Validity

B. External Validity

2) Once these companies begin producing their drug, most of the time
(in factories located in third world countries,) we must hope they actually produce what they state to the FDA they will. The FDA does not have the resources to check on all plants around the world.

If you visit the FDA site, in the search area, type "warning letters"- These letters are where the FDA has indeed inspected a plant, and found standards to be profoundly sub-par.




It simply makes one worry...and rightly so.....