Posted on 09/16/2019 11:37:47 AM PDT by CondoleezzaProtege
If you’re a layperson, this is the way you probably think of generics: They’re the exact same products in different packaging...
In October the Food and Drug Administration took a highly unusual step: It declared that a generic drug it had previously approved — a version of the popular antidepressant Wellbutrin — was not in fact “bioequivalent” to the name-brand version. The FDA withdrew its approval.
...Generic drugs diverge from the originals far more than most of us believe. For starters, it’s not as if the maker of the original pharmaceutical hands over its manufacturing blueprint when its patent runs out or is challenged. The patent reveals the components, but it doesn’t explain how to make the drug. In reality, manufacturing a generic requires reverse engineering, and the result is an approximation rather than a duplicate of the original.
The FDA’s rules effectively acknowledge that. The agency’s definition of bioequivalence is surprisingly broad: A generic’s maximum concentration of active ingredient in the blood must not fall more than 20% below or 25% above that of the brand name. This means a potential range of 45%, by that measure, among generics labeled as being the same.
There are other differences. The generic must contain the same active ingredient as the original. But the additional ingredients, known as excipients, can be different and are often of lower quality. Those differences can affect what’s called bioavailability — the amount of drug that could potentially be absorbed into the bloodstream. As the American Heart Association recently noted, “Some additives traditionally thought to be inert, such as alcohol sugars, cyclodextrans, and polysorbate-80, may alter a drug’s dissolution, thereby impacting its bioavailability.”
That can result in drugs that release active ingredients into the blood far more quickly, leaving patients feeling dizzy or nauseated.
(Excerpt) Read more at fortune.com ...
I have Rx insurance and if a generic is available I’m pretty much stuck with it. Makes me wonder if they caused some of my problems recently found. I’ll probably never know.
The drug is exactly the same.
Excipients differ.
Generally this is no problem at all.
Ibuprofen is a great example where the generic is perfectly fine.
It would be rare for there to be a difference in effect for a generic vs name brand.
I have a medication that I can get over the counter for $20 a month.
The prescription brand name medication is not covered by my insurance. It would cost me $900 a month out of pocket.
The insurance used to cover it. I can tell no difference between the brand name and the OTC. I just have to take it twice a day instead of once.
Many people have different responses to various preservatives, which can be quite harsh whether ingested or topically applied (regulations on which vary by country)...also color-dyes!
Just taking ibuprofen as an example: I respond badly to Advil (its tablets moreso, but don’t care for the liquigel either) And while okay with Motrin, I find the bright neon-orange dye obnoxious even if I don’t have an actual allergy to it.
US pharmacies unfortunately don’t sell European brands like Nurofen, but at least CVS and Walgreens offer their own dye-free ibuprofen alternatives.
#FirstWorldProblems
I’ve found that the store brand Glucosamine supplement works better for me than any of the similar big name stuff. My joints generally feel better and lots of activity doesn’t bother me.
Oh good :)! So your body is happier AND it's less pricey. Win win!
For joints, a number of studies have shown that 15g of gelatin works far better than glucosamine supplements.
Gelatin is made from the marrow of cows and greatly enhances both skin and joints. (Apparently people used to eat a lot more bone broth, but we’ve stopped.)
I mix it into a protein drink in the AM. 1 tablespoon. But it works in cold or hot water (just don’t let formerly hot gelatin cool down or it turns to jello).
You can also just mix it into soup or whatever.
It is the responsibility of the patent applicant(s) to disclose in sufficient detail the knowledge a person skilled in the art of the invention to make the invention.
Are you claiming that drug patents should not be allowed because the patent disclosures are inherently insufficient?
Bioavailability often balances out over the long term since it takes over a day from food going in to it going out.
I don’t know all the legal ins and outs, only that as a layperson...I can’t just base my judgment on a product on the active ingredient. Through trial and error, I am able to differentiate my body’s responses to various brandname/generic versions of the ‘same’ product even if I can’t pinpoint just which ‘inactive’ ingredient(s) is the source of the varied response. (If any.)
The same goes for non-medicinal things too I suppose. Like preferring a supermarket brand of a food item as opposed to the name-brand.
The financial press is still in a full-court propaganda press on behalf of Big Pharma, I see.
I was hospitalized from taking generic Lasix (Furosemide) because it didn’t do a proper job of removing liquid from my body. My legs were swollen and weeping water and I had to be given Lasix via IV to get my water retention back under control. After I was released and went back to name brand, I had no more issues. Don’t tell me they’re the same.
Perhaps. And it wouldn't be a surprise. Judging even from the few responses here though, for now it does seem to be safer to err on the side of a brand-name version when it comes to prescription drugs. But over the counter items...or even supermarket-brand food items, there is more room for flexibility and may even be preferable to brand-name.
Sorry, but they are the same.
You have either a good lawsuit or an interesting pharmacogenomic profile.
And, the latter would not rule out the former.
I’m quite serious. You have a valid lawsuit.
generics have from 80% to 120% of the active ingredient in their offering.
be aware.
Keep in mind glucosamine is not a drug but a dietary supplement.
Manufacturers need to show its afety, but do not need to show it is bio equivalent to any other glucosamine on the market.
“Apparently people used to eat a lot more bone broth, but we’ve stopped.”
I see bone broths sold at supermarkets now. Rather expensive.
They’re easy to make, though.
“The financial press is still in a full-court propaganda press on behalf of Big Pharma, I see.”
It’s funny because I am not one of the hysterics about evil big Pharma. That started out as leftist anti-capitalist attacks and seems now to have infected plenty of conservatives.
The funny part is that I agree with your comment above and that’s what I thought when I read this article.
Hence the recommendation for gelatin. It’s pennies a serving.
You do know my peoples’ reputation for parsimony, correct?
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