I don't take offense at ignorance, and that's what we have here - a lack of knowledge on part of those who claim differences in generic vs. name brand.
How do I know, I was an analytical chemist working with a formulation development team at a medium sized generic facility. I worked tens of thousands of hours working to ensure the formulations we created were 100% as bioavailable as the innovators product. This included human clinical trials after we got it down in vitro.
The USP or in house analytics published methodology for testing of active pharmaceutical ingredient and the fillers and binders. These methods were FDA approved as well to ensure our testing facilities were up to snuff.
Our QC lab handled all returned products from customer complaints. Back then (90s - early 2000s), not sure about now exactly, If you take a bottle of tablets back to a pharmacy and state that the generic isn't the same as the innovator's drug you used to take, or just claim inefficacy, the tablets were sent back to us for testing.
I very rarely saw these samples come in, as we rarely had complaints, and half the time it was a time release formula that doesn't dissolve in the body and is excreted in the feces. This is by design, still we tested the pill that someone dug out of their turd for remaining active ingredient and compared results to that documented during the clinical trials. If their was too much or too little remaining of the API (active pharnaceutical ingredient) we had to recall the batch. Recalls were extremely rare, very costly and extremely embarassing. Nonetheless, I found my company's executives to be highly ethical and we never burried data. We bit the bullet and issued whatever level of recall the FDA agreed was apprpriate, or whatever they dictated if we disagreed. You can look up recalls on the FDA's website.
We never recalled anything except levothyroxine (T4, synthroid "generic")7 - in quotes b/c there is no true innovator b/c that drug is so old it was grandfathered in when the FDA began to recognize patentened products and generics seperately (thats a simplification but it's accurate).
I digress. We made oral tablets and capsules, if that is of interest to you. We did not make parentals b/c the requirements for cleanliness, sterlity, particle content, stability and most significantly the packaging procedures are on par with that of high end silicone chip production and we simply could't make money doing those formulations. As it was our facility was as clean and well operated as any innovators - most of our development executives came from the innovators, and we paid them a ton to get them to jump ship. They were our biggest human assest. They ensured we did things exactly as they had in the innovation industry.
Unfortunately due to changes in the law Big Pharma has practically killed genuine generics, paying off the truly independent generics to not market their product, in many cases.
There is no in vivo or in vitro difference b/w genrics and the innovators. If their were we never would have been in business.
There was a generic drug "scandal" in the late 1980s. Since then oversight is so tight that you can be assured that there is no difference b/w formulae. In fact often you think you're buying a generic when in fact you're getting the innovators drug pressed in a different die, or the innovator licensed their formulation to a generic company so that the development work I did became unecessary. In that case there is naturally some variation in apperance. But be certain, as licensed, the innovator holds the generic to tighter standards than even the FDA in regards to quality and equivalency.
So I laugh.
10,000 hours minimum I worked at this, I know how many times we had drugs approved and how many we failed on. Let's just say it is often very difficult work, but when we got it right - bam! We had it.
We sent in our aNDA and always got approval, often after a few tweaks most having to do with labeling or additional testing they wanted us to do. We did that. We'd get approved. Then we'd get sued by the innovator for whatever reason they could get a judge to agree to accept as grounds for an 18 month injunction against our selling the compounded product we had sold for maybe a few weeks before the judge issued an injunction. Fuck me that sucked. Delay my bonus again....
I finally left the industry in frustration. But in the end most of my company's products were submitted and approved - some we just couldn't get right and we did fail at times and not submit an aNDA and would move on to a different compound. Once we made it through court and FDA appeals and then we made money. Until the company was bought out by a Big Pharma outfit from Switzerland. Eventually becoming part of Novartis.
So....
There ya are. They are the same. Plesase stop misinforming people.
This applies to the US, EU, and most strictly in Japan.
EDIT: You can search my posts, or those under my former username, speedball_racer, and find very similar posts where I explain this, there is more than one here at BL I've written before in response to this common complaint. It's like the vaccine debate, but even more ludicrous.
Are there occasions where a bad generic gets through the approval processes, yes. About on par with innovated products upon release or formulation change. The FDA posts much of the data on approvals, denials, revocations and recalled products, or you can request it, if needed do a FOIA request for a generic drug and read for yourself. Often someone will have already FOIAd a drugs aNDA and the FDA has the data ready to send. Otherwise it can be costly and take time. You need to have a reason to be requesting a FOUA, so I'm sorta being a wise ass, but my company did this many times to get FDA communications b/w an innovator and FDA if it pertained to complaints about our work.
I'd post approved product data, but it is 1000s of pages and I'd have to sort out the proprietary from the publicly available, so just go to the FDA with concerns.
File an "adverse drug report" (they've been renamed recently, but the process remains in place) if you had a health issue you believe was related to a product, I did once for a batch of generic Suboxone that was definitely high in naloxone, maybe within limits but I'm extremely sensitive to it, I now take generic Subutex. Never had a bad generic 'Tex, and I've had half a dozen or more formulae.
Thank you.
