View Full Version : Generic - inspections by FDA For Quality


wonderboy
07-21-17, 03:15 PM
About 65% to 75% of generic drugs are manufactured in countries that I guarantee you would not want to live.

And it is profoundly sad that the FDA fails to check these facilities in what anyone would deem to be an appropriate time frame...for issues such as quality control and bioequivalency

As I stated in my first text on this topic, generic companies do their --own testing-- before they seek approval, and the results of their testing is ----not made public-----

Bioequivalency can vary plus or -20%…

**It is important to understand that it is the generic company that establishes and conducts their study

* you know that ---"confirmation bias"-- exists.....--profoundly--

Also, they keep secret bioequivalency of their product

If there is nothing to hide, why not open the books

Little Missy
07-21-17, 03:41 PM
Who is in charge?

Good luck finding that out.

If so, maybe we should visit in person with that person.

wonderboy
07-21-17, 04:15 PM
Concerning their tests, we simply have to take their word for it

Little Missy
07-21-17, 04:17 PM
Concerning their tests, we simply have to take their word for it


No one is ever accountable. Really disgusting.

wonderboy
07-21-17, 04:44 PM
Yes it really is. And I do not understand why generic companies do not make their bioequivalency data available to the public

Little Missy
07-21-17, 04:57 PM
Yes it really is. And I do not understand why generic companies do not make their bioequivalency data available to the public

It probably wouldn't be correct anyway. I have a problem with statistics as that they can be manipulated.

sarahsweets
07-22-17, 08:26 AM
The irony is some doctors and pharmacists have the nerve to act like we are crazy for noticing differences in generic formulations of the same drug. I was never one to even believe it to be the case until the last two years dealing with my adderall.

wonderboy
08-11-17, 11:04 PM
This issue (the fact that the FDA) does not have the resources to inspect many pharmaceutical manufacturing in remote countries.


Also, The fact that a generic company does not have to disclose their own
bioequivalence tests that THEY perform before receiving FDA approval for marketing

Talk about weak internal and external validity..

wonderboy
08-12-17, 08:03 PM
The most startling and upsetting fact about how a generic company is approved by the FDA is the entire process:

Take Adderall for example.

When a generic company decides it would like to manufacture Adderall, it must conduct bioequivalency testing.

The issue I have with this is that the testing is completed solely by the generic company, and the results are not available to the public, only to the FDA.

Why not allow the public to know what the test showed, and how --specifically-- was the test conducted.

Was their appropriate internal and external validity.

The entire process is flawed in my opinion. Just an opinion

Little Missy
08-12-17, 09:14 PM
The most startling and upsetting fact about how a generic company is approved by the FDA is the entire process:

Take Adderall for example.

When a generic company decides it would like to manufacture Adderall, it must conduct bioequivalency testing.

The issue I have with this is that the testing is completed solely by the generic company, and the results are not available to the public, only to the FDA.

Why not allow the public to know what the test showed, and how --specifically-- was the test conducted.

Was their appropriate internal and external validity.

The entire process is flawed in my opinion. Just an opinion

It is not just an opinion. Its the truth.

Asthma inhalers are the same way. I don't even know WHAT Pro-Air is but a big blobby mess that never sprays, so I get Ventolin. It works.

Xanax generic brands, only Greenstone actually work, who else knows what. But what exactly can we do about it? Frankly, it stews the hell out of me.

Little Missy
08-12-17, 09:25 PM
And I miss the old Teva footballs. They were always so reliable and nice.

wonderboy
11-19-17, 12:01 AM
Yes it really is. And I do not understand why generic companies do not make their bioequivalency data available to the public


When a generic company decides to produce any medication, Adderall or whatever, they should make their testing (bioequivalency testing) that they, and emphasize, "they" should not hold their results as proprietary or secret… What is the purpose? Let the people know exactly what the testing displayed.

Moreover, you cannot tell me that there are not "demand characteristics" at play when these generic companies submit an application for a new generic drug in their testing process.


The process is a sham in my opinion