Posted by gilbert on December 2, 2001, at 2:10:49
In reply to Brand Vs. Generic : The (Close as Possible) Truth!, posted by jay on December 1, 2001, at 14:10:29
Jay,
Thank you for the info.....I had already seen some of that on the FDA websites. The problem occurs not in the FDA tesing for ingredients or bioflav.........the problem comes in due to the fact the FDA does not have resources nor the employees to do follow up testing during long periods of time when generics are manufactured. Look at my post above and see Elizabeth's comment. Search down below there were similar complaints about Mylan about 2 months ago. As a matter of fact if you talk to a Mylan rep, which I did. She was a nurse who handeld complaints and would do phone interviews to determine the and diagnose the problems customers were having. She could not tell me the reinspection protocol that the FDA requires....how often, how much etc. She told me that the FDA could do random checks on the drugs to determine their continued fitness as a generic. I asked when the last time the FDA did one of those checks was......HMMMMM, she did not know. So all the approval process and checks and balances put into place to be able to produce generics are fine but afterwords is a different story.
As far as the cost savings part of your research goes, most of that will become ancient history. The generics for each subtype of drug are being bought out by larger companies so they can control most or all of the market place for certain types of meds. The politics of pharamcy contracts and health provider approvals leaves even more room for customer choice to be edged out. For instance right now I cannot get greenstone generic anywhere near my home all of the companies have switched away to Mylan.
As far as generics being as effeicent as the original......in a perfect world maybe. If the drug comppany has to cut costs to get the contract from the health provider or the large chain pharmacy.....call me skeptical but I think we will be the ones on the short end of the stick. Maybe just maybe the FDA will get lucky and on a random check will find low amounts of apralazom in their test batch......do you think the manufacturer goes out of business then.....no at worst they get fined and recall the batch.
I have had other generics in different medication classes all behave differently. I have never had a generic behave exactly as the real thing.....close but no cigar. Close does not bother me it is when it is not close that it does. So all of the FDA assurances in the world don't change a thing unless they are on the line in the manufacturing facilities on a regular basis.......which they aren't.
The bigger problem is that the pharmeceuticals are watched less than the comapany that sells you ground beef. At least meat companies have to have an on premise inspector. The FDA's job at this point in American history is damage control not to mention some of the corruption that has taken place shooting drugs thru phases so fast it would make your head spin.
So I appreciate your insight but in my real world the generics ahev flunked out about half the time. I have has some good generics....it's just hard to predict which time is gonna be which.
Gil
poster:gilbert
thread:85386
URL: http://www.dr-bob.org/babble/20011123/msgs/85796.html