I wonder if the point of this, is to have us weigh getting "brand name" more seriously. There is no sensible reason to pay a premium for brand name if the generic is chemically equivalent.
It's been common, for instance, for people to repeatedly be berated for paying more for name brand. Studies in fact, of the public health economics of it, why people pay more for name brands, trying to understand it as if there are deficiencies in consumer reasoning.
This is despite repeated problems with generic suppliers overseas, mainly India, diluting medications. This was uncovered, problems were corrected, and then it happened again.
And now this.
So who exactly is the rational purchaser? The person who buys generics under the assumption that they are chemically equivalent, or the skeptic who prefers to have transparency about where their medications are coming from, and purchases brand names?
My point isn't to berate the FDA as incompetent -- I think they're overburdened -- but I do think there are broader problems involving a disconnect between how we discuss regulatory systems in the US and what actually happens. To me, this is just the tip of the iceberg. My personal opinion is the FDA needs to focus solely on this kind of problem -- ensuring drugs are what they are labeled to be -- with maybe some substantial research into effectiveness -- and to drop its regulatory role as drug police.
(Polish, Czech and Slovakian.)
It's primarily based around different characteristics of how the medication dissolves in the patient's stomach, or the differences between fillers and binders.
> There is no sensible reason to pay a premium for brand name if the generic is chemically equivalent.
If they're not chemically equivalent and have different medicinal effects as a result, then it's much easier to justify a price difference. I understand chemistry is more than just a list of ingredients. It's how those ingredients are combined that gives them their unique interactions.
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.
The packaging can have a surprisingly large effect on drug absorption, and therefore efficacy. Notably with difficult to dissolve drugs a lot of work typically goes into formulating them to be more efficiently processed by the intestinal tract.
The fillers in the generic don't have to be the same as the branded product, but the drug does have to behave the same as the branded product.
This was a psychiatric drug, and so of course, reports of problems went unheeded for years because patients were assumed to be imagining things.
Saying "the drug does have to behave the same as the branded product" is like saying "the product as delivered does have to match the spec".
It’s not a perfect process, but it works in nearly all the cases.
We know that in nearly all the cases, any issues don't rise to the level where the FDA or the public identifies them. I doubt that the system is constructed in such a way that nearly all the problems are identified.
It seems to me that because drugs are developed to meet the absolute minimum standards for proving efficacy and safety, there's inherently going to be little if any margin for error in the manufacturing process and hardly any way to analyze problems. When reporting potential side effects, most drugs are going to be just above the noise level in their principle effect, so how are you going to determine what is a random unrelated issue and what is a negative side effect, and what is the consequence of a QA or design failure?
My physician had prescribed "Diovan, not Valsartan" last year because of this. My pharmacist called me up as I was driving home from the physician's office. He assured me that he wasn't buying anything from that Chinese company, and observed that I'd be going from $65 per three months to $365 per three months. OK, generic it is...