And yet my mother is 100% convinced that the generic of a drug gives her chronic headaches while the "brand name" version doesn't.
If I'm not mistaken, the formulation could be wildly different as long as they match kinetics, yield, and safety profiles set by the FDA, and an individual may have some issue with one formulation over another.
I think the natural engineer intuition is that if a drug is just a chemical, and generic and name-brand drugs are the same chemical, how could there possibly be any difference? Don't be duped by advertising, save the money, be rational, etc.
One interesting case where there was a real problem was with generic extended-release bupropion (an antidepressant). The time-release mechanism on one of the generics didn't work correctly, although the manufacturer managed to get it past the FDA (they actually tested only a 150mg dose, and extrapolated the results to approve the 300mg dose).
There are studies showing that some generics don't perform as well as the brand name. Different formulations of the same drug (e.g. extended release medications, different sized particles in inhalers, etc) can have vastly different effects.
Part of the problem is that the name brand drug is sometimes better than the generic, and one generic brand is sometimes better than another. I have experienced this as a patient.
There have been a few examples where the FDA received complaints, looked at the data and asked the generic manufacturer to rest test/reformulate their drug since it wasn't therapeutically equivalent.
The best example is generic Wellbutrin[1]. Many patients complained of side-effects from generics that they didn't experience with the brand-name drug. The FDA did testing and realized that the generic Wellbutrin extended-release resulted in much high blood concentrations than the branded version. The generics in questions were withdrawn from the market.
The interesting thing is that to get approval for an "AB-rated" (therapeutically equivalent) generic drug, you don't have to be identical. The FDA only requires that the generic drug deliver 80-125% of the drug the branded drug does[2]. Normally that range is fine, but for some drugs (antiepileptics are a good example) the differences can produced a less than equivalent therapeutic outcome.
I believe there's probably some differences - especially in packaging. Some medications are different between generics or between generics and name brand in bioavailability. The title of the article isn't backed up by the content though in this case.
Recently I was switched to a brand-name after a decade+ on generics. The difference was obvious and really surprising to me as I figured the same chemical compound would produce identical results. The facts described in the article would explain the difference. Really sucks for people that need medication to be rolling the dice every month.
There are examples of generics that were different than the branded versions. Wellbutrin is a great example. A few generic versions were pulled since they dissolved at a different rate and delivered much higher doses of drug and causes side effects. Same thing with a few version of valprolic acid for epilepsy.
The law states the generic should be within 80% to 125% bio-equivalent of the branded version. Normally that's good enough, but for some drugs it causes problems.
> In the US to market a generic you need to show that it’s the same as an existing approved product currently on the market.
On a related note, you don't need to show that it's actually the same, just that it's close enough. And that doesn't always work out for the best. An easy example being anticonvulsants. My younger brother died from an epileptic seizure and post-death examination determined the active ingredient of the anticonvulsant he was taking wasn't present in his blood. He had just been switched from brand-name to generic. Come to find out that this is/was a known issue that the FDA hadn't figured out how to solve. The generics aren't made using the same process and the end result isn't identical to the real drug.
Also, my friend who works at a pharma factory says brand names have much tighter quality control - more batches are tested with far less tolerance.
In addition, some of the details of the chemicals (such as I guess the angles of the molecules) may be different, because the generic manufacturer imperfectly reverse engineers the process used to make the drug.
Clinical trials to validate the generic are less strict.
The FDA standards for generics are 80% to 125% of AUC and Cmax (measures of bioavailability). So you could be getting up to 20% less or 25% more drug with a generic than the brand. Sometimes that matters, sometimes it doesn't.
A great example of a generic drug problem is with Wellbutrin, used for smoking cessation and as an anti-depressant. The FDA allowed Teva to market their 300 mg pill without actual bio-equivalence testing (they just extrapolated from the lower dose) and as a result a lot of patients had bad side-effects. Teva recalled the product.[1]
In some cases, the generics have to prove that they have the same effectiveness/bioavailabilty as the brand name. The brand names have been restricting the distribution of the drugs to prevent this from happening easily.
That's partially BS generics are not always the same as brand name drugs. The manufacturing facilities are not the same the suppliers of active ingredients and the degree to which they are purified are not the same. So if insurance is covering brand name drug it's actually better it be prescribed vs generic.
This surprised me a bit but generics are not always a de-branded version of a medication or the same formulation manufactured by a different company. Often times generic equivalents are different formulations (sometimes prior generation formulas and sometimes divergent formulas) that are considered to have the same effect.
They nearly always do, but the weirdness of our stupid patent system means that sometimes they can have weird allergenic effects or (especially with neurological medicines that are less well understood) differing efficacy.
While the FDA does a fantastic job of reminding the population of the process it uses to ensure generics deliver the same experience, there is still a ton of waste in the system due to brand-name drugs being chosen over generics. Part of the problem is the massive marketing efforts by pharma trying to convince patients and doctors that their brand-name drug is better. For details see:
Yet we see drugs that are, say, 100 times the cost of the generic. So how can that happen; how is that sustainable? Presumably nearly everyone starts on the generic, and then switches to the brand name if they have problems with the generic. So there is actually not competition so much as price discrimination! You can't tell someone who the generic has failed that they are equivalent, because their only hope is that they are not! Not only is the generic no longer an alternative, but psychologically, it's easier to put your hope in a super-expensive option because of the cliche "you get what you pay for".
So I think telling people continually that generics are identical is not helpful, because it's not information. It's an assumption, which might be true or it might not be, but is essentially never helpful to any individual in making a decision.
I wonder how many patients had their complaints written off for the six years the generic was on the market?
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