![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 24 to 48 of 62. Go back in thread:
Posted by laima on February 26, 2007, at 18:11:36
In reply to Re: Drug manufacturing and quality control, posted by Squiggles on February 26, 2007, at 12:21:30
Well- for me the Barr generic and the Shire brand adderall behave like two entirely different meds: radically different effects, not a matter of potency. So I am not quite "getting" this bioequivalency thing, though I comprehend that's the theory and intention for generics. I'm just not so sure it's always the reality. If the difference in this case was a matter of potency, I could simply take more. Biggest concern: one makes me depressed and feels like speed at times-especially when it suddenly kicks in, then later it ends in a "dump"; the other boosts my mood gently but significantly, and feels like not being on a drug at all-no perceptable anything as it wears off-takes effect so gradually I can't even tell how long after I take it that that is. My doctor is the sole person who is not surprised by any of this, and I'm sorry that I end up feeling defensive about it not just at the numerous pharmacies I visited while hunting for it, but here. It's not my imagination, and I'm not a pharmaceutical industry spokesperson on an anti-generic crusade, nor a mental case perceiving imaginary differences. Sorry there haven't been any answers or clues regarding my big question about who is now specifically calling the shots in the manufacture of the brand version, I guess no one really knows at this point, and really, sorry I mentioned anything at all. Insisting that what I'm experiencing with these meds isn't imaginary only makes me feel worse.
Posted by laima on February 26, 2007, at 18:13:54
In reply to Re: Drug manufacturing and quality control, posted by Squiggles on February 26, 2007, at 12:21:30
Thanks for the link, Squiggles. I really appreciate, and I'll do some research there later.
Posted by psychobot5000 on February 26, 2007, at 21:35:05
In reply to Re: Drug manufacturing and quality control » Squiggles, posted by laima on February 26, 2007, at 10:11:41
>
> Yes, I guess you are right.
>
> I confess I've been a bit obsessed with the topic this weekend because of my own personal freak out over discovering that the manufacturer of my least helpful generic, a generic which actually ended up harming my mood, just took over the brand version of a med which worked out very, very well for me,
>
I thought it might be useful to mention that, last time I heard about this issue, there seemed to be some people saying that Mallinckrodt Pharmaceuticals' generic dexamphetamine was as good as brand-name dexedrine. I have taken Mallinckrodt's version and found it effective. Perhaps the Mallinckrodt adderall (it exists) would be good quality as well.
Posted by laima on February 26, 2007, at 22:48:08
In reply to Re: off-brand manufacturer » laima, posted by psychobot5000 on February 26, 2007, at 21:35:05
Thank you, I really appreciate this information. it may come in handy.
>
> I thought it might be useful to mention that, last time I heard about this issue, there seemed to be some people saying that Mallinckrodt Pharmaceuticals' generic dexamphetamine was as good as brand-name dexedrine. I have taken Mallinckrodt's version and found it effective. Perhaps the Mallinckrodt adderall (it exists) would be good quality as well.
Posted by notfred on February 27, 2007, at 10:36:09
In reply to Re: Drug manufacturing and quality control, posted by laima on February 26, 2007, at 18:11:36
"So I am not quite "getting" this bioequivalency thing,"
Take a look at what Cam W or Ed UK have had to say about this, that might make it more clear.
Posted by laima on February 27, 2007, at 11:23:38
In reply to Re: Drug manufacturing and quality control, posted by notfred on February 27, 2007, at 10:36:09
You know what- you all can prove whatever you like about "bioequivalency", but the issue in this particular case is, Shire brand adderall and Barr generic adderall behaved LIKE TWO ENTIRELY DIFFERENT MEDS. That's the practical reality. Theories can't help me with that. So I don't care if they technically are considered bio-equivalent by anyone, for they produce SEVERLY distinct effects for me. THAT's what the problem is. After looking at some ADD blogs last night- lo and behold- loads of people had the same sorts of distinct reactions to Barr generic vs Shire regular as me. I'm grateful that at least I have a doctor who acknowledges that indeed, there can be differences of action with some generics vs some brand versions of the "same" meds.And if Barr bought Shire's adderall- will there be subtle changes enacted, ones deemed insignificant "biologically"? Ie, different suppliers of raw materials, shortcuts in cooking, whatever- that render it ineffective or unhelpful for me?
And do you really think the fda is carefully monitoring quality of generic drugs, when they've barely got any grip on brand name situations, ie zyprexa, and new drug trials? Not to mention looking into the fake drugs which are being reported as showing up in US pharmacies? Illegal importations? Monitoring online pharmacies? They are kind of behind on inspecting meat plants, spinache processing centers, peanut butter- do you really think they are scrutinizing every single generic medication carefully and regularly for quality conrol, and that every single manufacturer, out of the goodness of their hearts, is doing a top notch job of not skimping somewhere??
And if they are supposedly the same, why is Barr now working with a generic AND a brand version of same "bioequivalent" medication? And spent a fortune to buy it-especially since they already had their own "bioequivalent" version? They didn't kill it- they could have killed it and raised their own prices. Pharmacies push generics, so I doubt they were losing tons of sales to the much more expensive brand version offered by Shire. Walgreens seems to eclusively offer Barr generic for generic adderall- sounds like a profitable deal? But what about choices for consumers?
I've already noticed a new effect which I can't attribute to being psychsomatic. My appetite has VANISHED. When I am upset, I eat more, not less. I'm starving. I love food- but it now seems appealing in theory only. Sure, stims can do that- but somehow I haven't experienced this before anywhere near to this extent. Not even close. Even when my stomache was so messed up that I required an endoscopy- I ate. So what's up? And the new "brand" of Adderal, courtesy Barr, is the only new variable that I've got going.
I know you are a wikipedia fan- I did notice that they were a bit, how shall we say, "nuanced" in their "generic drugs" article.
> "So I am not quite "getting" this bioequivalency thing,"
>
>
> Take a look at what Cam W or Ed UK have had to say about this, that might make it more clear.
Posted by notfred on February 27, 2007, at 12:41:26
In reply to Re: Drug manufacturing and quality control » notfred, posted by laima on February 27, 2007, at 11:23:38
>
> You know what- you all can prove whatever you like about "bioequivalency", but the issue in this particular case is, Shire brand adderall and Barr generic adderall behaved LIKE TWO ENTIRELY DIFFERENT MEDS.
Right, that is the difference between bioequivalency and bioavailability. amphetamine is either amphetamine or it is not, there is no grey area as it is a very specific molecule, as all drugs are. Just because it is the same molecule does not mean both are of equal bioavailability
and would cause one med to be very different from the other.
Posted by laima on February 27, 2007, at 13:06:53
In reply to Re: Drug manufacturing and quality control, posted by notfred on February 27, 2007, at 12:41:26
Ok then, I appreciate your clarification of the definitions.>
> Right, that is the difference between bioequivalency and bioavailability. amphetamine is either amphetamine or it is not, there is no grey area as it is a very specific molecule, as all drugs are. Just because it is the same molecule does not mean both are of equal bioavailability
> and would cause one med to be very different from the other.
Posted by laima on February 27, 2007, at 13:18:37
In reply to Re: Drug manufacturing and quality control, posted by notfred on February 27, 2007, at 12:41:26
Yes, seriously, thank you for the clarification. I've had so many pharmacists, and a few others, insist that my perceptions of the differences are imaginary, that the drugs are "exactly the same", that it's a touchy and upsetting topic for me. Some of the pharmacists actually rolled their eyes and sighed dramatically at me even when I politely tried to explain, please, I want the version that was prescribed, they feel very different to me. Yes, very upsetting. So I'm out of the discussion- I'm just too touchy right now- though still gratefully welcome any helpful tips or constructive suggestions anyone might have.And thanks again for your definitions- yes, of course, I can understand that an amphetamine is an amphetamine. Can't disagree. It's those "other factors" which seem to be the difficulty.
> Right, that is the difference between bioequivalency and bioavailability. amphetamine is either amphetamine or it is not, there is no grey area as it is a very specific molecule, as all drugs are. Just because it is the same molecule does not mean both are of equal bioavailability
> and would cause one med to be very different from the other.
Posted by notfred on February 27, 2007, at 13:45:28
In reply to Re: Drug manufacturing and quality control » notfred, posted by laima on February 27, 2007, at 13:18:37
Ah ! Sorry I did not pick up on this & that it was not clear I was agreeing with you.
For many drugs you cannot just take the raw drug and expect it to be well/evenly absorbed. Often times raw drugs cannot be made into pills as the raw drug will not bind to itself, so binders and fillers are needed to form a pill that will hold its shape. Other additives make sure the med is released at the right place in your GI and/or is released smoothly. With the wrong additives it is possible to pass a pill through your GI without it ever breaking up.
Brands have to prove bioavalibility, generics do not prove that their bioavalibility is equal to the brand. Standards like USP make sure generic prozac is the same chemical as brand prozac but it is a totally different issue as to how well the generic prozac is taken up by your body vs. the brand.
Posted by laima on February 27, 2007, at 14:29:07
In reply to Re: Drug manufacturing and quality control, posted by notfred on February 27, 2007, at 13:45:28
Well, gosh, I can personally say it hasn't helped that I've been feeling so defensive and invalidated by umpteen pharmacists and pharmacy techs-that one being so bold as to say she was going to give me generic and over-ride the doctor's instructions even- so maybe if I read your post more carefully and without emotional investment the nature of the content would have been more obvious to me. Sorry about a misunderstanding. Thanks for all of your info.
> Ah ! Sorry I did not pick up on this & that it was not clear I was agreeing with you.
>
> For many drugs you cannot just take the raw drug and expect it to be well/evenly absorbed. Often times raw drugs cannot be made into pills as the raw drug will not bind to itself, so binders and fillers are needed to form a pill that will hold its shape. Other additives make sure the med is released at the right place in your GI and/or is released smoothly. With the wrong additives it is possible to pass a pill through your GI without it ever breaking up.
>
> Brands have to prove bioavalibility, generics do not prove that their bioavalibility is equal to the brand. Standards like USP make sure generic prozac is the same chemical as brand prozac but it is a totally different issue as to how well the generic prozac is taken up by your body vs. the brand.
Posted by laima on February 27, 2007, at 15:25:20
In reply to Re: Drug manufacturing and quality control » notfred, posted by laima on February 27, 2007, at 14:29:07
Before this unfortunate misunderstanding and generic vs brand debate, I actually did have a question. So- despite being hassled and scoffed at at pharmacies, I have stuck to my vow to insist on getting the Shire version of adderall, because it is the version that I've tried which worked out really, really well for me. Too bad it's the expensive version, but oh well. Then suddenly viola! I discovered that just this January, Barr aquired Shire's "brand version". So, having had such an uneven and ultimately bad experience with Barr's generic, my fear has been- what if they do something which ends up changing how "brand" works for me? What is it about their generic that doesn't make it work well for me, and will any of those factors now be introduced into the "brand" version? Will they use different suppliers than Shire for raw materials, or adjust the manufacturing process, or any other seemingly insignificant factors, which could add up to it acting differently? Obviously, it's scary to think that a sucessfully helpful med might vanish immediately after one discovers it. So one, I was trying to figure out who is actually in charge now, and what specifically this aquisition means. Did they just take over the profits, allowing it to still be made by the same people in the same place, etc--or did they take control over the entire manufacture? I haven't yet had any luck at all in trying to dig up this information. Mostly found a load of news stories about a currently active lawsuit by Barr vs Shire, Barr trying to get Shire to give up their patent for AdderallXR several years early- ironically arguing that Shire currently has a monopoly on AdderallXR-something like that. Ok.Naturally, I've tried to detect if there is any difference with this new version, but understand that maybe I'm not being objective enough to do so accurately right now, due largely to my fear and suspicion. I guess time will tell, after I chill out and stop scrutinizing. I do feel like I am feeling it differently- but it's only day 4, and I am well aware that my perceptions can be influenced by my concerns. I hate to use the term "psychosomatic"- but I can't think of a better one now. Here's my perceptions: I feel more depressed in the evening than before- not a full blown crash, but not an absence of crash, as before. I speculate this could indeed be psychological. Ok. Another thing I noticed is that 3 normal size glasses of wine over 3-4 hours, and with lots of water in between, made me very drunk last Friday (day 1)- and that is NOT what has ever happened before. Ok- there could be numerous reasons, including a light dinner. My perception of time seems to be different- it is suddenly feeling to zoom by at incredible speed. I don't get this part- when I'm upset- time usually slows down. I have insomnia, thoughh I haven't changed my dose schedule- no adderall past 1pm. Insomnia hasn't been a problem until just now. Ok- either the new med is hanging around longer, or this is psychological. But the factor that I am really least able to attribute to psychology is the very sudden and dramatic vanishment of my appetite. (Well I guess those last few zyprexa pounds won't be a problem anymore soon!) Again, when upset or fretting- I crave carbohydrates and tend to over-eat. The other stims I've used have had some modest appetite supression effects for me, but nothing major. Quite negligable. I've had no problem on them eating proper meals or even snacks. I'm always normallly very interested in food! It's this last factor, appetite, which has me concerned that the medication might be different now. Well, of course, regardless of what's going on, I guess I don't really know what I can do other than wait and see how the month goes, and if it doesn't go well, start looking into alternatives. Also talk to doctor at next appointment to see if he's got any info or opinions as to whether this stuff is psychological or not. Barr's only taken over less than 2 months ago-could they have even made any changes yet, if they even intend to? The tablets look exactly the same as before, if that matters.
So yes- I guess my question really was meant to be- has anyone else suddenly switched from Shire IR Adderall to this new Barr IR Adderall- any observations? And, anyone know the scoop on what specifically is going on with this particular Barr aquisition? Do these changes I perceive sound psychological, or drug-attributal?
And what on earth is up with the pharmacies all pushing generics so heavily? I would have thought they'd want to push brand, that brand versions would be more profitable for pharmacies. (Or is this just Walgreens, to whom, alas, my drug coverage insurance is tied to?) ?
Thank you.
ps- If anyone is using Barr and is happy with it- lucky you! I wish I could say the same- just doesn't work well for me.
I don't mean to offend.
Posted by Larry Hoover on February 27, 2007, at 15:34:48
In reply to Re: Drug manufacturing and quality control, posted by notfred on February 27, 2007, at 13:45:28
> Brands have to prove bioavalibility, generics do not prove that their bioavalibility is equal to the brand. Standards like USP make sure generic prozac is the same chemical as brand prozac but it is a totally different issue as to how well the generic prozac is taken up by your body vs. the brand.
I just checked the FDA site, and I'm going to have to say you've got it wrong, Fred. Generics must pass bioavailability studies, as part of demonstrating bioequivalence.
Here's the offical FDA definition of 'bioavailable':
"the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action...."Here's the official FDA definition of 'bioequivalent':
"the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study."In the case of a generic drug, an application for an ANDA (abbreviated new drug application) must contain both BA and BE data, and the specific reported parameters (e.g. AUC, PPC) must fall within 80-125% of the values for the original (reference) drug. There are also special additional regulations for delayed release, XR, or CR generics. The take home message is that bioavailability is subsumed by the larger concept, bioequivalence. Two drugs with different bioavailability cannot be bioequivalent, and such a generic drug should not pass the FDA review.
Here's a nice slide show that sums up the concepts better than the text of the legislation itself: http://www.fda.gov/cder/ogd/02-10_BCBS_gjb/sld001.htm
If you want to read a more technical explanation, go to: http://www.fda.gov/cder/guidance/4964dft.htm
Of course, a generic company can submit whatever they choose, just as the original pharma companies are certainly guilty of doing. But there's another problem that I really think has been subjected to a cover-up; last year, a company that specialized in doing bioequivalence studies for generic drug manufacturers was accused of submitting completely false data. Some studies were never even done. I believe that 180 ANDAs were suspected to have been falsified? Something like that. After the initial press flurry, I never heard another word about it. Does anybody else remember hearing about this?
Lar
Posted by laima on February 27, 2007, at 15:52:17
In reply to Re: Drug manufacturing and quality control » notfred, posted by Larry Hoover on February 27, 2007, at 15:34:48
Wow- I never heard that! Horrifying!My doctor, a pharmacologist involved with some overseeing or monitoring of drug trials (something like that), has told me that generics are typically not as closely scrutinized by the fda as brand versions, though. The statement seemed neutral in judgement, part of a longer explanaition about possible reasons why some generics do not appear to be identical to the originals they are supposedly identical to.
Yet I had presumed part of the reason for that was that they were already considered safe and up to snuff?
Wow.
That's an intense story.
I did notice a brief "breaking news" blurb in the New York Times about two weeks ago- and then quite quickly it and the story vanished before I was able to go back to reread properly. Something about fbi or fda- someone pulled a surprise raid on Ranboxy Labs US office and shuffled through a load of papers, removing some documents, "no further info available", though a Ranboxy official confirmed it occured. Wonder what that was about?
Posted by Squiggles on February 27, 2007, at 16:07:55
In reply to Re: Drug manufacturing and quality control » notfred, posted by Larry Hoover on February 27, 2007, at 15:34:48
I propose that BA is easier to botch, and get away with, as many environmental circumstances, such as storage, temperature, age an be overlooked. And I would guess that when there are problems between generics and trade variations, it is not the bioequivalence that has not passed the test but the bioavailability.
Squiggles
Posted by Larry Hoover on February 28, 2007, at 13:29:04
In reply to Re: Drug manufacturing and quality control » Larry Hoover, posted by laima on February 27, 2007, at 15:52:17
>
> Wow- I never heard that! Horrifying!Well, I debated for days, even mentioning it, for that reason. I really didn't want to stir the pot, but it's potentially very relevant to our discussion. Perhaps it's gone quiet while they investigage. Far better to have proof of due diligence up front, but that's not the way the system works.
I must frequently remind myself that the medical system was not like it is today, only a few decades ago. Different hospitals offered different treatments; there was no standardized care as we know it today. Different doctors offered different drugs for the same maladies, or did experiments on patients without any real oversight. Drug companies passed no muster before offering up a new treatment. Snake oil was literally available.
We're trying to forge an entirely new system of oversight, while still functioning with all kinds of unexamined remnants of the past. There are bound to be failures, whether due to fraud or simple human frailty. Anybody remember the "ulcer diet"? Who knew that a simple course of antibiotics would be the cure.
I've drifted off track, haven't I?
I think one of the problems with generic drugs is that there is so much money flowing into that area of manufacturing that there are bound to be start-up problems. Quality control can be measured in so many different ways, yet only the end consumers' experiences are really relevant. If we make our collective voices heard, maybe we'll make a difference? E.g., if nobody wants Barr's IM dexedrine, surely they're going to be affected by cash flow issues? Eventually? <hoping>
Lar
Posted by Squiggles on February 28, 2007, at 16:57:28
In reply to Re: Drug manufacturing and quality control » laima, posted by Larry Hoover on February 28, 2007, at 13:29:04
Are you suggesting that we should boycott
generics?
Posted by Larry Hoover on February 28, 2007, at 17:14:37
In reply to Re: Drug manufacturing and quality control, posted by Squiggles on February 28, 2007, at 16:57:28
> Are you suggesting that we should boycott
> generics?No. Only ones that don't work right.
Lar
Posted by Squiggles on February 28, 2007, at 17:15:59
In reply to Re: Drug manufacturing and quality control » Squiggles, posted by Larry Hoover on February 28, 2007, at 17:14:37
Ha ha ha ha!!! Good one:-)
Squiggles
Posted by laima on February 28, 2007, at 18:28:25
In reply to Re: Drug manufacturing and quality control, posted by Squiggles on February 28, 2007, at 17:15:59
But I'd agree!
And I'm sure not all generic manufacturers are the same in their ethics or quality.
I'm personally feeling kind of down on Barr right now: I found their generic version of adderall to be unpredictable and ultimately quite harmful to my mood- and noticed on ADD boards that many people reported complaints about this particular generic that were identical to my own. Same bad effects. Of course, a few people like it- but I thought generics were supposed to be cheaper but identical equivalents to the originals, not behave like altogether distinct meds themselves? I thought the idea was that generics were supposed to be directly interchangeable with the brand versions? That's what all the notices posted around the pharmacies claim. I also find it peculiar that Barr went to the trouble to aquire the Shire original, and is now offering two versions of this medication, when their own generic version was supposedly identical to the original in the first place. And to top it off, they are currently suing Shire to give up the patent to Adderall XR several years early-claiming Shire has a monopoly on it. (Um- Shire invented it...) What's up with that, ethically? Let me guess- then next they will try to buy Shire's original Adderall XR, too? Will Shire then eventually give up developing newer, better meds if generic companies start a habit of suing them out of their patents? I mean, they can't develop drugs for free out of the goodness of their hearts, unfortunately- it has to be profitable- they need an incentive. Govt. doesn't seem interested in funding new drug development, as far as I can tell. So for the time being, I think we are stuck with capitalism. And where I live, pharmacy choices are basically Walgreens or CVS- with a sprinkling of Domonick's/Safeway. Lucky me, my drug coverage is tied to Walgreens. I don't even know of any independent pharmacy anymore. Walgreen's only generic version of adderall is Barr. One Walgreens in fact told me that they have an exclusive contract with Barr for generic "adderall". It's Barr or brand- and brand is now Barr, too. I'm starting to feel like my choices are Barr, Barr, Barr. And it doesn't work for me! And this generic version is no bargain for me or for anyone else who does poorly with it. I feel like the original Shire version worked great for me, and thanks to the generic company's takeover, it appears, feels to be gone. Choices shrunk. Ironically, it's the generic company here that seems to have the real monopoly on "adderalI". I don't like this situation at all.
> Ha ha ha ha!!! Good one:-)
>
> Squiggles
Posted by Squiggles on February 28, 2007, at 18:53:18
In reply to Re: Drug manufacturing and quality control » Squiggles, posted by laima on February 28, 2007, at 18:28:25
Frequently Asked Questions about Generic Drugs
1. What are generic drugs?
2. Are generic drugs as safe as brand-name drugs?
3. Are generic drugs as strong as brand-name drugs?
4. Do generic drugs take longer to work in the body?
5. Why are generic drugs less expensive?
6. Are brand-name drugs made in more modern facilities than generic drugs?
7. If brand-name drugs and generic drugs have the same active ingredients, why do they look different?
8. Does every brand-name drug have a generic counterpart?
9. What is the best source of information about generic drugs?1. What are generic drugs?
A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use.
back to top
2. Are generic drugs as safe as brand-name drugs?
Yes. FDA requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.
back to top
3. Are generic drugs as strong as brand-name drugs?
Yes. FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs.
back to top
4. Do generic drugs take longer to work in the body?
No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.
back to top
5. Why are generic drugs less expensive?
Generic drugs are less expensive because generic manufacturers don’t have the investment costs of the developer of a new drug. New drugs are developed under patent protection. The patent protects the investment—including research, development, marketing, and promotion—by giving the company the sole right to sell the drug while it is in effect. As patents near expiration, manufacturers can apply to the FDA to sell generic versions. Because those manufacturers don’t have the same development costs, they can sell their product at substantial discounts. Also, once generic drugs are approved, there is greater competition, which keeps the price down. Today, almost half of all prescriptions are filled with generic drugs.
back to top
6. Are brand-name drugs made in more modern facilities than generic drugs?
No. Both brand-name and generic drug facilities must meet the same standards of good manufacturing practices. FDA won’t permit drugs to be made in substandard facilities. FDA conducts about 3,500 inspections a year to ensure standards are met. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms are linked to an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.
back to top
7. If brand-name drugs and generic drugs have the same active ingredients, why do they look different?
In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different.
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8. Does every brand-name drug have a generic counterpart?
No. Brand-name drugs are generally given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial costs (including research, development, and marketing expenses) to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA.
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9. What is the best source of information about generic drugs?
Contact your physician, pharmacist, or insurance company for information on your generic drugs. You can also visit the FDA website at http://www.fda.gov/cder/ogd/index.htm for more information.
Consumer Education: Generic Drugs
Posted by laima on February 28, 2007, at 18:57:11
In reply to Re: Drug manufacturing and quality control, posted by Squiggles on February 28, 2007, at 18:53:18
Oh yes- I've seen this notice at the pharmacy. Good theory- this is how it should be. Too bad that in practical actual usage it's actually not always true. I've contacted my doctor for further info, as per the suggestion listed- and he agreed with me.
> http://www.fda.gov/cder/ogd/
>
> Frequently Asked Questions about Generic Drugs
>
> 1. What are generic drugs?
> 2. Are generic drugs as safe as brand-name drugs?
> 3. Are generic drugs as strong as brand-name drugs?
> 4. Do generic drugs take longer to work in the body?
> 5. Why are generic drugs less expensive?
> 6. Are brand-name drugs made in more modern facilities than generic drugs?
> 7. If brand-name drugs and generic drugs have the same active ingredients, why do they look different?
> 8. Does every brand-name drug have a generic counterpart?
> 9. What is the best source of information about generic drugs?
>
> 1. What are generic drugs?
>
> A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use.
>
> back to top
>
> 2. Are generic drugs as safe as brand-name drugs?
>
> Yes. FDA requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.
>
> back to top
>
> 3. Are generic drugs as strong as brand-name drugs?
>
> Yes. FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs.
>
> back to top
>
> 4. Do generic drugs take longer to work in the body?
>
> No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.
>
> back to top
>
> 5. Why are generic drugs less expensive?
>
> Generic drugs are less expensive because generic manufacturers don’t have the investment costs of the developer of a new drug. New drugs are developed under patent protection. The patent protects the investment—including research, development, marketing, and promotion—by giving the company the sole right to sell the drug while it is in effect. As patents near expiration, manufacturers can apply to the FDA to sell generic versions. Because those manufacturers don’t have the same development costs, they can sell their product at substantial discounts. Also, once generic drugs are approved, there is greater competition, which keeps the price down. Today, almost half of all prescriptions are filled with generic drugs.
>
> back to top
>
> 6. Are brand-name drugs made in more modern facilities than generic drugs?
>
> No. Both brand-name and generic drug facilities must meet the same standards of good manufacturing practices. FDA won’t permit drugs to be made in substandard facilities. FDA conducts about 3,500 inspections a year to ensure standards are met. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms are linked to an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.
>
> back to top
>
> 7. If brand-name drugs and generic drugs have the same active ingredients, why do they look different?
>
> In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different.
>
> back to top
>
> 8. Does every brand-name drug have a generic counterpart?
>
> No. Brand-name drugs are generally given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial costs (including research, development, and marketing expenses) to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA.
>
> back to top
>
> 9. What is the best source of information about generic drugs?
>
> Contact your physician, pharmacist, or insurance company for information on your generic drugs. You can also visit the FDA website at http://www.fda.gov/cder/ogd/index.htm for more information.
>
> Consumer Education: Generic Drugs
Posted by Squiggles on February 28, 2007, at 19:00:18
In reply to Re: Drug manufacturing and quality control » Squiggles, posted by laima on February 28, 2007, at 18:57:11
> Oh yes- I've seen this notice at the pharmacy. Good theory- this is how it should be. Too bad that in practical actual usage it's actually not always true. I've contacted my doctor for further info, as per the suggestion listed- and he agreed with me.
But how many cases have you seen? You say
it's not "always" true. How often has it been
false? And do you know why? I think that you may assume that the drug is different because it is generic, when so many other influences have been overlooked.Squiggles
Posted by laima on February 28, 2007, at 19:52:22
In reply to Re: Drug manufacturing and quality control, posted by Squiggles on February 28, 2007, at 19:00:18
"Other influences"- like my being delusional? Or you fancy I am someone who insists on brand-name designer products, or thinks that expensive=better? Hardly! All I want is for my medication to work properly.What I can guarentee you is that Barr generic "adderall" and the Shire brand Adderall felt like entirely different drugs: radically different effects. They might have had a few molecules in common, but they did not do the same thing- AT ALL. I can also guarentee you that I've seen other patient testimonials reporting the very same results that I got, and I read them after the fact-ie, was not suggestably influenced by them. I can also guarentee you that my doctor agreed with zero hesitation or reservation that generics are not necessarily the same as the original versions. Some are more notoriously different and are more often and vigorously complained about by patients than others. You might have noticed that prescription pads even have a section where the doctor can choose to indicate: "Do Not Substitute". I can guarentee you that until recently, I could go to Walgreens and choose Shire or Barr, and now I can choose have Barr or nothing. I thought generics were intended to offer consumers choices? I got less choice. And, in the US, I am pretty darn certain that generic manufacturers are just as interested in turning a profit as the developers and pharmacies are. They are not non-profit entities run by selfless philanthropists, smiled upon and encouraged by a kind and attentive government which has nothing but public welfare in mind. And I've seen plenty of reports of the fda being pretty overwhelmed and spread thin these days. Checking to be sure generics BEHAVE in the same way as originals doesn't sound to be a top priority. Nor does it really sound to be required, if you dig around deep enough into the rules of standards they need to meet.
Maybe it's a little like cooking: you can give a bunch of people the exact same recipee and groceries, but I know the results do not always end up tasting the same-despite the molecules presumabley being the same. It's usually due to their talents and methods. But with drugs- it's more serious- if the results do not end up with the same therapeutic benefits.
Since this seems to be turning into another case of touting the 'ole "generics are exactly interchangeable with brand name originals- any differences are imaginary", line, I give up. Anything I say seems likely only be used to demonstrate how delusional I am about my own experience by those who feel generics are a sincere and angelic public service, and so really, what's the point?
Yes, actually in the past there have been reports by several people here on babble asserting strongly that generic versions of clonazapam are not the same as brand Klonopin- but I don't have personal experience of comparing them myself. All I've ever personally noticed is that the current generic clonazapam Walgreens offers is weaker and much shorter acting than the one they used to offer. And that it has tended to fuzz me up rather than relieve any anxiety or worry.
If all your particular generics are working out great for you- fantastic! Count your blessings.
> But how many cases have you seen? You say
> it's not "always" true. How often has it been
> false? And do you know why? I think that you may assume that the drug is different because it is generic, when so many other influences have been overlooked.
>
> Squiggles
>
Posted by Squiggles on February 28, 2007, at 20:01:15
In reply to Re: Drug manufacturing and quality control » Squiggles, posted by laima on February 28, 2007, at 19:52:22
>
> "Other influences"- like my being delusional?
I'm waiting for the deputees to spank you. This is the second time offense has been given; another post to me was "do you like your sex kinky or straight". Nothing was done. Either these things are missed, or I am excluded from the rules here for some reason.Squiggles
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