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What I mean by "testing" is that the formulations are used in clinical trials and tested on human patients, not that batches of pills are tested to contain stated ingredients.
Are each of these generic formulations individually tested in clinical trials?
Absolutely yes!
The manufacturer must test and supply documentation to FDA. FDA also does spot checks
I didn't see it mentioned in any of the threads - but why is there the assumption that the 'Brand-Name' drug is more effective? There is a lot of discussion about the generic from one manufacturer being more effective than from another, but what about times when a generic form is more effective than that from the 'Brand-Name' due to the inactive ingredients?
Direct from the FDA link provided by charmed hour:
"Because generic drug makers are not required to repeat the clinical trials of new drugs and generally do not pay for advertising, marketing and promotion, generics are usually substantially less expensive than brand-name drugs."
Direct from the FDA link provided by charmed hour:
"Because generic drug makers are not required to repeat the clinical trials of new drugs and generally do not pay for advertising, marketing and promotion, generics are usually substantially less expensive than brand-name drugs."
What are you trying to say?
Clinical trials are to prove efficacy of the drug. That takes years and years and tons of money to accomplish. That is also why brand name drugs, once approved AFTER CLINICAL TRIALS FOR SAFE AND EFFECTIVE, are so damned expensive. That's also why the original manufacturer wants to protect it's patent for so long
Generic manufacturers do not need to repeat the clinical trials. They just have to be held to strict manufacturing practices.
If you want to waste your money on brand meds, go ahead. Insurance companies, except for very specific clinical reasons, will NOT COVER BRAND MEDS.
Sorry, but it's advertising and bribing doctors that takes up the larger portion of any drug's budget, right behind lobbyists. I know people in veterinary medicine and they would never get one single drug to market doing the small amount of tests on the small number of test subjects that human medications are allowed to get away with. And that's the brand-name ones.
The simple fact is that all generics are not made equal and anyone who has taken a medication over a long period of time and been switched knows it.
I have a huge problem with overheating. I can walk into a grocery store and shop for 30 minutes and standing in line, I look like I've run a marathon, with sweat dripping off my face and the back of my shirt completely wet.
I've been to multiple doctors about this and when I can finally find one who doesn't just pat me on the head and tell me it's menopause (trust me, it ain't), they run a thyroid test. It always comes back normal. In fact, my thyroid might be the most normal thing about me.
Thank you for the suggestion, though. And the rep!
My grandson has issues, it's one symptom of a connective tissue disorder although I'm not sure what the cause is. They make cooling vests. He normally walks around in his boxers, even in winter because he over heats so bad; especially with socks and shoes on
Very similar article in the NYTimes just recently with a lot of input by an FDA inspector (former) who said if you saw what he saw in manufacturing plants overseas, you wouldn't take any of these drugs. As if anybody would, given the choice.
Would you happen to have the link?
Quote:
Originally Posted by genesiss23
My favorite generics are the ones which are literally made by the brand manufacturer and people still say they are not good.
Perception is an issue when people rate how effective a drug is. A study gave people the same product but one group was told it was expensive and the other group was not told it. People in the expensive group reported better outcomes.
I have issues with generic oxycontin but not the brand one. My pharmacist had told me they had the same lot number and that they were the same thing. Funny, the generic made me throw up; even when I didn't know it was the generic. My father had the same experience back in 2006; throwing up from generic oxycontin but had no issues when I gave him my brand made pill. My pharmacist said that there was no way I had a reaction to it. I told him what happened, he couldn't believe it
Quote:
Originally Posted by mike1003
I'm sure that the drug was not fake at a store like Target
What I do know is that different generic manufacturers might use different inactive fillers. They might also press the tablet harder.
As a pharmacist, I know that there are rare issues of different responses when switching manufacturers. Unfortunately, today, staying on same mfr is not always possible due to back orders, company buyouts, etc.
I guess the brand made generic uses different fillers then they do with the more expensive brand name one.
Quote:
Originally Posted by noodlecat
Thanks for your input as a pharmacist. I would hope that it wasn't fake, but if it was, how would Target know? Are they visiting and inspecting the facilities where the raw materials are being sourced from? I'm not being flippant; I'm asking a serious question.
And are generic formulations tested for efficacy? My guess is no. So there are these pills out there where one ingredient (the actual drug) has FDA approval but it is mixed with fillers and that complete mixture is not tested and doesn't have to go through all the testing that the patented name-brand formulation did. And these fillers can potentially negate the active ingredient to more or less of a degree, or even cause return of symptoms or cause new side effects. Yet the FDA doesn't demand they be tested or approved.
I think it's somewhat disingenuous to claim that a certain pill is a generic for X name-brand drug, when in reality it's a different formulation that may or may not actually work as intended.
Agree. I wish insurance companies would still pay for brand name but none do from what I've seen
Quote:
Originally Posted by noodlecat
Thanks for the link. Several criteria are listed for the generic drug approval process, but none address the generic formulation *as a whole.* The focus is on the active ingredient, the dosage, the form, absorption rate. Inactive ingredients are apparently ignored because they are *assumed* to be inactive and therefore not able to possibly provide some kind of anti-synergistic effect. That is the blind spot. The fact that there are people such as myself having no problem with one generic formulation but the return of symptoms or the beginning of new side effects with another generic formulation of the same active ingredient is human-tested evidence that these "inactive" ingredients are actually "active" and doing something.
To the people who have left me rep comments, here is a link from that article to Medwatch where consumers can report their experiences. But even if the FDA selects your drug for testing, it will not investigate whether the "inactive" ingredients might be interfering with or deactivating the "active" ingredient. https://www.accessdata.fda.gov/scrip...mer.reporting1
I have issues with generic oxycontin but not the brand one. My pharmacist had told me they had the same lot number and that they were the same thing. Funny, the generic made me throw up; even when I didn't know it was the generic. My father had the same experience back in 2006; throwing up from generic oxycontin but had no issues when I gave him my brand made pill. My pharmacist said that there was no way I had a reaction to it. I told him what happened, he couldn't believe it
Most likely psychosomatic!
Quote:
Originally Posted by Roselvr
I guess the brand made generic uses different fillers then they do with the more expensive brand name one.
No, it would cost too much money for a manufacturer to reformulate and retool to remanufacture
It's the same
Quote:
Originally Posted by Roselvr
Agree. I wish insurance companies would still pay for brand name but none do from what I've seen
Only time I ever received a prior-auth for brand drug was when all generics were back-ordered
No, it would cost too much money for a manufacturer to reformulate and retool to remanufacture
It's the same
Only time I ever received a prior-auth for brand drug was when all generics were back-ordered
It's not psychosomatic and it's an insult to tell someone that it is.
A dr even told me once that the different drug companies are allowed to deviate a certain percentage with the formula--I can't remember what that percentage was but she said that she thought it was too large a percentage. That was about ten years ago and maybe things have changed. I don't know.
That was after I took a different generic and it didn't work but the first generic had worked. She said that this does happen and she ordered the generic I'd had the first time.
And just recently I had a prescription that didn't do anything at all. When I looked at the label, it had a different manufacturer on it. I called the pharmacy and asked if they had it in the generic brand that I usually got. They said they only had it in a larger dose. They said they can't help what brand they get; they have to take whatever they can get.
The pharmacist called my dr and they arranged to order the generic that had worked, get it in the larger dose, but with a new diagnosis so the insurance would pay for it, and instructions for me to take only 1/2 pill. whew.
This is an amazing and wonderful pharmacist who will actually go out of his way to talk to you and will call the doctor for you and have the prescription ready asap. I always get generics but the effectiveness differs from manufacturer to manufacturer.
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