![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 21 of 21. This is the beginning of the thread.
Posted by Collette1 on November 28, 2001, at 9:08:57
As many of us recently learned, Greenstone Labs makes the most authentic generic Xanax (alprazolam). Now my pharmacist says they are "back-ordered" meaning that they have NO IDEA when or if they will get more in! I am wondering if this is really true or if they just don't want the bother of my wanting them to order a generic other than the one they want me to use..by Mylan labs. Collette
Posted by gilbert on November 28, 2001, at 22:47:55
In reply to Anyone else have a problem getting generic Xanax?, posted by Collette1 on November 28, 2001, at 9:08:57
Did you see my post above, well today I called almost all of the pharmacies in the west metro area, all the chains and small owned pharmacies have switched to Mylan. Most don't even carry real xanax anymore by upjohn or greeenstone which is made by upjohn as well. The Mylan people called me back today due to the fact I emailed them to tell them their product was inferior. I was having to triple dose for same effects. They are sending me a sample container and are going to test my meds. I hope if they show weakness or inefectiveness they will be stand up people and let me know. Also the FDA does not regulate generics the way we belive they do. They only randomly show up to batch test drugs for strength bioflavabilty etc. It is not like the meat industry where a federal inspector is on site. I emailed Pharmacia(upjohn) to let them know that they are being pushed out of the Detroit area marketplace. I am having my doc rewrite my refills DAW dispense as written and will only be using xanax from Pharmacia from now on. Oh here is the real kicker it seems the generics are all being gobbled up by large companies so they can increase prices and make the marketplace less competitive....so we pay more for less. Another interesting fact is I called almost 12 drug stores and none I repeat none had original xanax in stock it was all special order, They all had 10 had Mylan 2 had Geneva....so even when you want to pay for the real thing they make it a hassle. DON'T LET PHARMACIES DECIDE WHAT IS GOOD FOR YOU.
I guess it't all about money and not about helping people get well.
FRazzled and Frustrated,
Gil
Posted by Collette1 on November 29, 2001, at 8:56:48
In reply to Re: Mylan taking over xanax market, posted by gilbert on November 28, 2001, at 22:47:55
> Did you see my post above, well today I called almost all of the pharmacies in the west metro area, all the chains and small owned pharmacies have switched to Mylan. Most don't even carry real xanax anymore by upjohn or greeenstone which is made by upjohn as well. The Mylan people called me back today due to the fact I emailed them to tell them their product was inferior. I was having to triple dose for same effects. They are sending me a sample container and are going to test my meds. I hope if they show weakness or inefectiveness they will be stand up people and let me know. Also the FDA does not regulate generics the way we belive they do. They only randomly show up to batch test drugs for strength bioflavabilty etc. It is not like the meat industry where a federal inspector is on site. I emailed Pharmacia(upjohn) to let them know that they are being pushed out of the Detroit area marketplace. I am having my doc rewrite my refills DAW dispense as written and will only be using xanax from Pharmacia from now on. Oh here is the real kicker it seems the generics are all being gobbled up by large companies so they can increase prices and make the marketplace less competitive....so we pay more for less. Another interesting fact is I called almost 12 drug stores and none I repeat none had original xanax in stock it was all special order, They all had 10 had Mylan 2 had Geneva....so even when you want to pay for the real thing they make it a hassle. DON'T LET PHARMACIES DECIDE WHAT IS GOOD FOR YOU.
>
> I guess it't all about money and not about helping people get well.
>
> FRazzled and Frustrated,
>
> GilThank you so much for responding! So you are going to get your Xanax directly from Upjohn now? This is just awful! Collette
Posted by Pamela Lynn on November 29, 2001, at 11:16:33
In reply to Anyone else have a problem getting generic Xanax?, posted by Collette1 on November 28, 2001, at 9:08:57
Collette,
Hi! I live in Northern New Jersey and have been (for over a year now) been taking the generic form of Xanax (from Mylan-Alprazolam 0.5MG). Now, I have never, ever had the 'real' Xanax, nor has my label on my bottle ever said Greenstone Labs....BUT, I have always had great results with the generic form that I do take. I mean, I take it for anxiety and it does the trick for me.
Actually, I just called my Pharmicist to ask him about this! He tells me that there is "absolutely no difference" between the Greenstone Labs that you mentioned and the Mylan (remember--'he'told me this). He told me that when they order generic of anything for the pharmacy that they use whatever the 'wholesaler' has in stock at the time of ordering. "HE" told me that ALL forms of Xanax-generic or not, ARE tested for potency, and that, in NJ at least, they have to pass the 'test' for potency or they don't market them.
Like my shrink, I trust my Pharmiscist, and hold him in the highest regard. I was VERY satisfied with what he had to tell me regarding the generic Xanax that I take. I wanted to be sure I was getting as good as the reg./non-generic form of Xanax; I am now pleased and assured that what I take is doing it's job.
P.L.
P.L.> As many of us recently learned, Greenstone Labs makes the most authentic generic Xanax (alprazolam). Now my pharmacist says they are "back-ordered" meaning that they have NO IDEA when or if they will get more in! I am wondering if this is really true or if they just don't want the bother of my wanting them to order a generic other than the one they want me to use..by Mylan labs. Collette
Posted by Collette1 on November 29, 2001, at 12:00:24
In reply to Re: Anyone else have a problem getting generic Xanax? » Collette1, posted by Pamela Lynn on November 29, 2001, at 11:16:33
> Collette,
>
> Hi! I live in Northern New Jersey and have been (for over a year now) been taking the generic form of Xanax (from Mylan-Alprazolam 0.5MG). Now, I have never, ever had the 'real' Xanax, nor has my label on my bottle ever said Greenstone Labs....BUT, I have always had great results with the generic form that I do take. I mean, I take it for anxiety and it does the trick for me.
>
> Actually, I just called my Pharmicist to ask him about this! He tells me that there is "absolutely no difference" between the Greenstone Labs that you mentioned and the Mylan (remember--'he'told me this). He told me that when they order generic of anything for the pharmacy that they use whatever the 'wholesaler' has in stock at the time of ordering. "HE" told me that ALL forms of Xanax-generic or not, ARE tested for potency, and that, in NJ at least, they have to pass the 'test' for potency or they don't market them.
>
> Like my shrink, I trust my Pharmiscist, and hold him in the highest regard. I was VERY satisfied with what he had to tell me regarding the generic Xanax that I take. I wanted to be sure I was getting as good as the reg./non-generic form of Xanax; I am now pleased and assured that what I take is doing it's job.
>
> P.L.
> P.L.
>
> > As many of us recently learned, Greenstone Labs makes the most authentic generic Xanax (alprazolam). Now my pharmacist says they are "back-ordered" meaning that they have NO IDEA when or if they will get more in! I am wondering if this is really true or if they just don't want the bother of my wanting them to order a generic other than the one they want me to use..by Mylan labs. ColletteWe had a big discusiion about this around a month ago and most who WERE ALREADY taking the Greenstone labs version were VERY unhappy when Mylan was suddenly forced on them. Mylan labs may "work" but the timing of how it enters your system is quite different and if you have always used the Mylan version, you are probably OK with what it does for you. Those of us using the Greenstone version( which is made by the makers of Xanax) found a big difference in the strength and speed with which it works. Perhaps it will just require an adjustment period, but I would prefer to get the brand name at this point. Glad it works for you. Collette
Posted by Pamela Lynn on November 29, 2001, at 12:27:51
In reply to Re: Anyone else have a problem getting generic Xanax? » Pamela Lynn, posted by Collette1 on November 29, 2001, at 12:00:24
Hmmmmmm....well. I surely am not saying you are wrong...but, from what my Pharmicist just told me this morning, (I was told that taking the generic form OR Xanax)that I would have the same effect on either of them.
I just called him back and asked if I could get the 'real' Xanax on my next refill (which is in about 3 days). He said not a problem, I would have to pay the higher price, but....this is a 'quest' (LOL) for me now....I want to see, first-hand what happens......If the 'real' stuff acts the same as the Mylan generic. My pharmiscist thinks it will be the same...Sooo, we shall all see! I'll let you know. (and, YES, I know everyone is different on meds..but I still want to see what, if anything, this does to me). I have to say though...I take the drug for my anxiety/panic attacks and it works VERY quickly and thoroughly (sp?), and that is what I have read that Xanax should do..generic or not.......
P.L.
> > Collette,
> >
> > Hi! I live in Northern New Jersey and have been (for over a year now) been taking the generic form of Xanax (from Mylan-Alprazolam 0.5MG). Now, I have never, ever had the 'real' Xanax, nor has my label on my bottle ever said Greenstone Labs....BUT, I have always had great results with the generic form that I do take. I mean, I take it for anxiety and it does the trick for me.
> >
> > Actually, I just called my Pharmicist to ask him about this! He tells me that there is "absolutely no difference" between the Greenstone Labs that you mentioned and the Mylan (remember--'he'told me this). He told me that when they order generic of anything for the pharmacy that they use whatever the 'wholesaler' has in stock at the time of ordering. "HE" told me that ALL forms of Xanax-generic or not, ARE tested for potency, and that, in NJ at least, they have to pass the 'test' for potency or they don't market them.
> >
> > Like my shrink, I trust my Pharmiscist, and hold him in the highest regard. I was VERY satisfied with what he had to tell me regarding the generic Xanax that I take. I wanted to be sure I was getting as good as the reg./non-generic form of Xanax; I am now pleased and assured that what I take is doing it's job.
> >
> > P.L.
> > P.L.
> >
> > > As many of us recently learned, Greenstone Labs makes the most authentic generic Xanax (alprazolam). Now my pharmacist says they are "back-ordered" meaning that they have NO IDEA when or if they will get more in! I am wondering if this is really true or if they just don't want the bother of my wanting them to order a generic other than the one they want me to use..by Mylan labs. Collette
>
> We had a big discusiion about this around a month ago and most who WERE ALREADY taking the Greenstone labs version were VERY unhappy when Mylan was suddenly forced on them. Mylan labs may "work" but the timing of how it enters your system is quite different and if you have always used the Mylan version, you are probably OK with what it does for you. Those of us using the Greenstone version( which is made by the makers of Xanax) found a big difference in the strength and speed with which it works. Perhaps it will just require an adjustment period, but I would prefer to get the brand name at this point. Glad it works for you. Collette
Posted by gilbert on November 29, 2001, at 17:14:27
In reply to Re: Anyone else have a problem getting generic Xanax?, posted by Pamela Lynn on November 29, 2001, at 12:27:51
The pharmacists all say the same thing. I talked directly to Mylan labs yesterday and quality assurance is the isuue. Once the drug companiy gets licensed for FDA approval for making generics the FDA dissappears. I asked the nurse from Mylan how aften the FDA tested their products during or after manufacturing she did not know......unbelievable. They are testing my sample right now. I can tell you I have had all 3 brands you mention and if you dissolve them sublinguinally you will notice a huge difference in the strenght of flavor. also huge differences in efficafacy.
Sorry to disagree but i is my experience and I do consider myself a xanx connosseur.......LOL
Gil
Posted by gilbert on November 29, 2001, at 18:39:23
In reply to Re: Pamela Lynn, posted by gilbert on November 29, 2001, at 17:14:27
Please excuse my spelling in the previous post, I was in a hurry to get to the airport.......sorry.
Gil
P.S. Whenever you complain about generics the companies always want to bring up placebo effect and blame it on you the consumer. The pharmacists at my CVS said the same things yours did and I love my phamacist she is great. But facts are facts and just because a drug passes bioflav. testing and is within the FDA approved guidlines for generics does not make it a gauranteed perfect process from that day forward. In most cases generics are fine but I do notice differences. This batch of Mylan xanax I received last week just about put me in withdrawal. Thank God my mom had some Upjohn to get me through until I saw my doc. The really distubing thing about the generics is that with all the mergers and buyouts it won't be long before the generic marketplace is controlled by a slim few. Once a drug store chain contracts with those companies that will be your only choice....Once the drug company making the generic contracts with your health provider you will really be backed into the corner. This does not seem to me to be a free marketplace econonmy, which is what we are supposed to be. The reason behind generics was to offer affordable choices to people who needed them. Look at the Mylan website and see the HUGE list of drugs they are involved in producing....it will blow your mind. This is turning from a free marketplace to an oligopoly and will soon be a monopoly. This will not induce lower prices or high quality products without good old American competition. What will the incentive to turn out high quality xanax be for someone who already has 80% of the market share and contracts with all the major drug stores plus is on the preferred drug list for all of the HMO's and PPO's. This really get's disheartening when you see how corrupt the process really is.
Gil
Posted by Pamela Lynn on November 30, 2001, at 1:14:55
In reply to Re: Pamela Lynn, posted by gilbert on November 29, 2001, at 17:14:27
Well, hey, no problem...you can have your own opinion-of course!! I still say that I trust my Pharmacist and don't know why he would 'lie' to me, ya know? It is very unbelievable that a nurse AT Mylan couldn't answer your question for you, very strange indeed.
I will soon be getting the 'real deal' with the Xanax and will be the judge all for myself. I am sure if there IS a difference in strength, I will feel it soon after taking it. If I am not getting the 'proper' Xanax, I soon will be! But, again...the whole point of 'me' taking the Xanax, er ah..Alprazolam, is to take care of my anxiety/panic attacks, and one more (and last) time, the pills I take work wonderfully for me.
As for taste...darn, the one's I have now, by Mylan, they just taste AWFUL...I've had one stuck in the back of my throat on more then one occassion-YUCK!!
Thanks for your input...and no biggie on the spelling! LOL
P.L.
> The pharmacists all say the same thing. I talked directly to Mylan labs yesterday and quality assurance is the isuue. Once the drug companiy gets licensed for FDA approval for making generics the FDA dissappears. I asked the nurse from Mylan how aften the FDA tested their products during or after manufacturing she did not know......unbelievable. They are testing my sample right now. I can tell you I have had all 3 brands you mention and if you dissolve them sublinguinally you will notice a huge difference in the strenght of flavor. also huge differences in efficafacy.
>
> Sorry to disagree but i is my experience and I do consider myself a xanx connosseur.......LOL
>
> Gil
Posted by Pamela Lynn on November 30, 2001, at 1:26:53
In reply to Re: sorry about my spelling, posted by gilbert on November 29, 2001, at 18:39:23
I just read your "P.S." here...What I have to say about that is this:
My pharmicist told me that he could order ANY and/or ALL different 'brands' of the Xanax, regular and generic for me to try. He said he could special order anything that I needed. Your pharmacy might strictly stick to one certain company and may be only able to get you one certain brand of the Xanax...but mine doesn't, as I stated in a previous part of this thread (will only repeat this one more time here, I promise) I AM getting, from my pharmicist, to try, the other Xanax manufactured by the different company.
I might be alittle slow here, but I think I am 'hearing' you right here....But to the best of my knowledge, the consumer always has a right to have either the 'generic' form of a med. or the 'name brand' of a med. (Although one has to pay more for the brand name!)
Thanks for listening to me.
P.L.
> Please excuse my spelling in the previous post, I was in a hurry to get to the airport.......sorry.
>
> Gil
>
> P.S. Whenever you complain about generics the companies always want to bring up placebo effect and blame it on you the consumer. The pharmacists at my CVS said the same things yours did and I love my phamacist she is great. But facts are facts and just because a drug passes bioflav. testing and is within the FDA approved guidlines for generics does not make it a gauranteed perfect process from that day forward. In most cases generics are fine but I do notice differences. This batch of Mylan xanax I received last week just about put me in withdrawal. Thank God my mom had some Upjohn to get me through until I saw my doc. The really distubing thing about the generics is that with all the mergers and buyouts it won't be long before the generic marketplace is controlled by a slim few. Once a drug store chain contracts with those companies that will be your only choice....Once the drug company making the generic contracts with your health provider you will really be backed into the corner. This does not seem to me to be a free marketplace econonmy, which is what we are supposed to be. The reason behind generics was to offer affordable choices to people who needed them. Look at the Mylan website and see the HUGE list of drugs they are involved in producing....it will blow your mind. This is turning from a free marketplace to an oligopoly and will soon be a monopoly. This will not induce lower prices or high quality products without good old American competition. What will the incentive to turn out high quality xanax be for someone who already has 80% of the market share and contracts with all the major drug stores plus is on the preferred drug list for all of the HMO's and PPO's. This really get's disheartening when you see how corrupt the process really is.
>
> Gil
Posted by gilbert on November 30, 2001, at 1:43:13
In reply to Re: sorry about my spelling » gilbert, posted by Pamela Lynn on November 30, 2001, at 1:26:53
The choice issue is simply not that easy. If CVS is contracted for Mylan generic you cannot then get greestone generic or geneva generic unless you can find a drug store that is contracted to carry that brand. As for paying for the real deal....you have to pray to God your health insurance will accept a DAW script from your pdoc and many don't thereby forcing you to pay for the full script if you want the real deal and not just the deductible. So the decision isn't really yours.....if your on a budget. I don't know where you live but in Michigan all of the big chain drugstores in the metro area all have switched to Mylan you could not get geneva or greenstone even special order....I tried. The only special order item you can get is Xanax or the original and some pharmacies won't even do that for you....I also checked into that. When I took my new script DAW for xanax I had more than one store try to once again give me Mylan and would not special order the Xanax because they simlpy don't moove enough of it. Most don't even have regular xanax in stock. I had one phamacist tell me to go to the hospital pharmacy that was my best bet. So I pray to God your area does not end up like it is here. If the Mylan works for you don't change it....if it ain't broke don't fix it............Good Luck,
Gil
Posted by Pamela Lynn on November 30, 2001, at 8:05:26
In reply to re; consumer's choice, posted by gilbert on November 30, 2001, at 1:43:13
I'll go over it one more time here! I totally feel like i'm not being listened to.
I have TALKED to my pharmicist, he has told me that I he can EASILY order either the Mylan brand again, the 'real deal' (which, yes, I acknowledged that it could be costly..but if want it I can certainly get it) or the other generic form that was mentioned earlier on this thread. Now..why would my pharmiscist tell me he can order me anyone that I want if I can't get it???? I am going there today, as a matter of fact, to get my script renewed-a different Xanax.
I live in NJ, and I would think that maybe things are law-wise different here. I don't know...I only know what my shrink and my pharmicist tell me.....
It feels to me like you are simply looking to pick an arguement with me..well you won't get one here....Kindly, actually 'read' what I write...One last time...It is VERY easy for me, from my pharmicist to obtain any of the generic, or the real deal Xanax.
GOSH...all this over generic Xanax and obtaining them! PHEW..
This is all I will post on this matter...thanks for 'listening'. Be well, and Happy Holidays.
P.L.
> The choice issue is simply not that easy. If CVS is contracted for Mylan generic you cannot then get greestone generic or geneva generic unless you can find a drug store that is contracted to carry that brand. As for paying for the real deal....you have to pray to God your health insurance will accept a DAW script from your pdoc and many don't thereby forcing you to pay for the full script if you want the real deal and not just the deductible. So the decision isn't really yours.....if your on a budget. I don't know where you live but in Michigan all of the big chain drugstores in the metro area all have switched to Mylan you could not get geneva or greenstone even special order....I tried. The only special order item you can get is Xanax or the original and some pharmacies won't even do that for you....I also checked into that. When I took my new script DAW for xanax I had more than one store try to once again give me Mylan and would not special order the Xanax because they simlpy don't moove enough of it. Most don't even have regular xanax in stock. I had one phamacist tell me to go to the hospital pharmacy that was my best bet. So I pray to God your area does not end up like it is here. If the Mylan works for you don't change it....if it ain't broke don't fix it............Good Luck,
>
> Gil
Posted by gilbert on November 30, 2001, at 13:16:36
In reply to Re: re; consumer's choice » gilbert, posted by Pamela Lynn on November 30, 2001, at 8:05:26
Wow,
I thought what we had going on was simply a difference of opinion. A healthy exchange of ideas. I certainly did not intend to make you feel like I was picking a fight. The facts are the facts and I am just relaying what I went through so others may avoid the same problem, you know to try and be helpfull. I never doubted what you said about what was happening in New Jersey, I was simply letting you know what was happening in Michigan. I don't have the same flexability with our pharmacies here that you do there. Maybe some other's across the country would be in the same position I am in. As far as belittling my complaints over making a "big deal over generic xanax"....I feel that is quite insensitive. The drugs I received were completely ineffective. I don't think that is a laughing matter or something trivial. When people depend on medication to function normally and are give an inferior alternative it can be a life changing experince, certainly someone like yourself with panic should understand that. I am not trying to convert you away from Mylan like my last post said if it works go for it. But I certainly don't appreciate the tone of triviality or impuning my integrity over this topic. You have not had to walk in my shoes this past week. I would hope that others who suffer from the same afflictions would have compassion for one another instead of being judgemental and intolerant of ideas that might be different from what makes them secure. The importance of this board is that those of us who suffer from mental illness can exchange ideas about medication whether generic or not and hopefully not be attacked for stating our opinions. If you felt like you were being attacked I would like to apologize I don't have the power or the writing skills to put into words what this week was like for me after 3 great years of progress. I have had others on this board disagree and agree with me on many issues but at no point at any time have I ever been treated like I was a liar or making a big deal out of nothing. Many people depend on this board for support so maybe prior to posting that should come to mind....to be supportive....not trivializing someone elses problems or insinuating that they are misinforming others. That simly is not the case here. I will post the results from Mylan labs good bad or indiffererent for others on this board who have had the same experience.
I do wish you the best and I do hope you continue to have the wonderfull choices and options you speak of, I just wish the rest of us were that lucky.
God Bless
Gil
Posted by Pamela Lynn on November 30, 2001, at 15:02:33
In reply to No more arguments here, posted by gilbert on November 30, 2001, at 13:16:36
Listen, you obviously took me WAY WRONG (as you say I took YOU wrong)...I am one of the most sensitive people around, and "I" don't like being told otherwise...if you have read some of my other posts, you would see that I am VERY sensitive and get along VERY well with others that post here...Actually quite a few (4 to be exact) posters have been emailing me...and I have only been posting for about alittle over 2 weeks (I monitored the board for about a month before posting).
I certainly know what it is like to have panic attacks...and you know what? I wouldn't want to walk in your shoes..as I am sure you wouldn't want to walk in mine..BUT, I do empathize with you, and am TERRIBLY sorry if I gave you the impression that I was anything other than empathetic!!!!
On that...I TOTALLY end this. I hope you are feeling better and good luck with the Xanax.
Pamela Lynn
> Wow,
>
> I thought what we had going on was simply a difference of opinion. A healthy exchange of ideas. I certainly did not intend to make you feel like I was picking a fight. The facts are the facts and I am just relaying what I went through so others may avoid the same problem, you know to try and be helpfull. I never doubted what you said about what was happening in New Jersey, I was simply letting you know what was happening in Michigan. I don't have the same flexability with our pharmacies here that you do there. Maybe some other's across the country would be in the same position I am in. As far as belittling my complaints over making a "big deal over generic xanax"....I feel that is quite insensitive. The drugs I received were completely ineffective. I don't think that is a laughing matter or something trivial. When people depend on medication to function normally and are give an inferior alternative it can be a life changing experince, certainly someone like yourself with panic should understand that. I am not trying to convert you away from Mylan like my last post said if it works go for it. But I certainly don't appreciate the tone of triviality or impuning my integrity over this topic. You have not had to walk in my shoes this past week. I would hope that others who suffer from the same afflictions would have compassion for one another instead of being judgemental and intolerant of ideas that might be different from what makes them secure. The importance of this board is that those of us who suffer from mental illness can exchange ideas about medication whether generic or not and hopefully not be attacked for stating our opinions. If you felt like you were being attacked I would like to apologize I don't have the power or the writing skills to put into words what this week was like for me after 3 great years of progress. I have had others on this board disagree and agree with me on many issues but at no point at any time have I ever been treated like I was a liar or making a big deal out of nothing. Many people depend on this board for support so maybe prior to posting that should come to mind....to be supportive....not trivializing someone elses problems or insinuating that they are misinforming others. That simly is not the case here. I will post the results from Mylan labs good bad or indiffererent for others on this board who have had the same experience.
>
> I do wish you the best and I do hope you continue to have the wonderfull choices and options you speak of, I just wish the rest of us were that lucky.
>
> God Bless
>
> Gil
Posted by jay on December 1, 2001, at 14:10:29
In reply to Re: I AM NOT insensitive to anyone! » gilbert, posted by Pamela Lynn on November 30, 2001, at 15:02:33
I hope this clears the air on some of the questions. You all have valid points, but please read.
---
http://cpmu.org/Generics.html
Generic Versus Brand Name Prescription Drugsby David V. Mihalic
Temple University
School of PharmacyMany people feel generic versions of prescription drugs are inferior for the same reasons that generic versions of their favorite shampoos or cereals are inferior. However, though they are called "generic," these prescription drugs are expected to meet the same standards required of the innovator or brand name product. The Food and Drug Administration is required to review and inspect the generic version of a drug just as they would with an "innovator" or brand name product.
In 1984, legislation was passed that ushered in the beginning of the generic drug era. The Drug Price Competition and Patent Term Restoration Act, or Waxman-Hatch Act, passed in 1984, allowed for lawful production and distribution of generic drugs. Four years after this Act was passed the generic drug industry was rocked by scandal as it was discovered that some ten or more generic companies had fraudulently represented data to the Food and Drug Administration (FDA) to gain approval for their generic version of a drug5. This was largely due to the pressures of dozens of companies competing to get approval for generics that could mean millions of dollars to those companies. The FDA’s procedures for approving these generic drug applications were inadequate to evaluate the overwhelming number of applications being submitted. The pressure applied by the generic drug firms on the FDA was immense and many drugs were not reviewed with the scrutiny they should have been. As a result, the bad press from this scandal created a feeling that generic drugs were inferior and potentially harmful. This feeling has, in many cases, survived to this day. Shortly after this event, the FDA reevaluated its procedures and protocols and examined 2800 samples of generic drugs right off the shelves5. Since 1990, the FDA has been conducting inspections of generic drug facilities to ensure that data collected is valid and that the facilities are within the standards set forth by the FDA for sterility and purity. These inspections include review of records, sample batches of the drug, the production facilities, the environmental control of batch storage areas, and the labeling procedures used to prevent medication mix-ups. The FDA has assured, through these inspections, that the generic drug product the patient receives is of comparable quality to the brand name product.
The major difference between a brand name drug and a generic is the research required for the innovator (brand name) company to discover the new biochemical substances that eventually become new drugs. This research is essential to finding new and better treatments for various diseases, but can be expensive. On average it can cost a drug company about $500 million to bring a new drug to market. While much of this cost is passed on to the consumer, the pharmaceutical industry returns most of the money to research and development of new products and you can see why this is important.
The FDA grants the innovator (brand name) company a patent of exclusivity making it the only company able to produce and sell the drug. The patent expires 20 years from the start of drug development to drug marketing. When it does, generic companies are then allowed to manufacture and sell the drug.
For the healthcare industry, generic drugs offer significant savings to consumers. The cost of generic drugs averages 40 to 60 percent below the cost of the innovator or brand name drug4. For this reason 63.0% of HMOs in 1997 required the dispensing of generic drugs, when available, over brand name drugs in order for them to decrease costs of drug therapy 1. A relatively recent case in point came with the advent of a generic form of the antihypertensive drug, captopril (Capoten). Originally, the cost of this prescription drug was about 73 cents per tablet or $73 dollars per 100 tablets. After generic versions were produced, the price dropped to $5 dollars per 100 tablets2. In an industry that is increasingly cost conscious, the healthcare industry has found its cost-savings savior in generic drugs.
So, is a generic drug just as good as the brand name version? The generic company’s version of the drug has the same active ingredient with the same chemical purity as the brand name drug. Other ingredients such as tablet fillers, binders, coatings, or flavors may be different. The generic company does not have to submit data to the FDA regarding the effectiveness and safety of the medication because the innovator (brand name) company has already established these. This results in a significant cost savings for the generic because it does not need to spend the research dollars the innovator spent to create the drug originally. For this reason, it costs the generic company less to market the drug and this savings can be passed on to the patient.
When an innovator’s patent for a drug expires, generic companies may request to the FDA, through an application called the ANDA (Abbreviated New Drug Application), to manufacture and sell their version of that drug. The ANDA, though smaller in size than the NDA (New Drug Application) that innovators are required to submit, is an extensive document containing many sections addressing the ultimate safety and effectiveness for that drug.
The FDA focuses on two main areas in the ANDA. One area is the Chemistry and Manufacturing section. For orally administered drugs, this section provides data to the FDA that must prove that the company can manufacture the drug product and that each unit of drug is consistent in potency, stability, and sterility. The second section is the bioavailability or bioequivalence section. This section is a collection of data that must prove that their version of the drug can attain the same absorption from the gastrointestinal tract to the bloodstream as the innovator’s product. This issue is so important that generic drugs are rated by it. The rating system is based on a two-letter code (for example AA, AB, and B_ ). A generic that is AA rated has essentially the same absorption to the bloodstream (bioavailability) as the innovator’s product. A generic that is AB rated (most generics are AB rated), has had differences in bioavailability from the innovator that have been resolved to the satisfaction of the FDA. A generic drug that is B (whether it is BB, BO, BP, etc…) rated does not have the same bioavailability as the brand name product and they should not be used interchangeably without the knowledge of your doctor and pharmacist. This does not mean that a generic drug that is B rated is not good or can not be used. It simply means that if you are started on that generic, you should not switch to the brand name or vice versa especially if that drug has a narrow therapeutic range (the concentration of the drug in the body has to be monitored carefully, such as warfarin, digoxin, or anticonvulsants). There are not many B rated generic drugs on the market.
The fact that generic drugs are similarly regulated to brand name drugs should confirm their safety and effectiveness when used properly. As previously stated, generic drugs contain the same active ingredient as the brand name, but fillers, flavorings, or coatings may differ. Because of these differences, a patient may find he/she is allergic to an excipient (inactive ingredient) found in the generic version which is not contained in the brand name version. However, this occurs at the same likelihood as someone having an allergy to an excipient in a brand name drug. In fact, if a person is known to have an allergic reaction to an excipient in the brand name product, it may be advisable to use the generic version if it does not contain that excipient. Cases like this are generally rare as these common fillers and flavorings are found in many non-drug products as well.
Finally one must also consider this. With the potential to lose millions of dollars to a generic company’s product, many brand name companies have now either bought smaller generic companies or created their own. What this means is that the generic drug you are taking could have come out of the same production facility as the brand name product. The only differences are the labeling, tablet or capsule design, and the price. They also continue research and development for new products. It is reported that almost 80% of generic drug products made in the United States are made by brand name firms7. Therefore, with regard to most generics made in the United States, the generic version is identical in all but perhaps appearance.
Key Points to Remember:
Generic drugs are not inferior to brand name versions.
If you have any questions about your prescription drugs, you should ask the pharmacist if the generic version is A rated or B rated compared to the brand name.
Remember that B rated does not mean the generic is bad, it simply means it should not be freely interchanged with the brand name version without the knowledge of your doctor.
You can ask your pharmacist if the drug you may be taking is a drug with a narrow therapeutic index. Drugs in this category should be closely watched if you have switched from a brand name drug to a generic that is B rated.
You should also check with your doctor to see if the drug concentration in your system would need to be checked after such a change. Drugs in this regard may include warfarin (Coumadin), phenytoin (Dilantin), levothyroxine sodium (Synthroid), and digoxin (Lanoxin), among others.
As always, you should tell your physician and pharmacist about all the medications you are taking; including over-the-counter products (e.g. TylenolÒ , MotrinÒ , or other pain relievers, cold/cough preparations), herbal remedies and vitamins.
Bibliography
Waltermire, Richard D. RPh., MS "Direct-to-Consumer Advertising of Rx Drugs Can Be Harmful to Your Health." Drug Benefit Trends. 10(10): Pg 60-61, 1998, SCP Communications, Inc..
Sakson, Steve "Competition Cuts Into Generic Drug Firms’ Bottom Line" The Associated Press Sunday May 11th, 1997. 50 Rockefeller Plaza, New York, N.Y. 10020.
Alper, Philip R., M.D. "Are Generics Taking Over?" HealthLine Magazine December, 1995.
"The Importance of Generic Drugs" PCS HealthSystems, www.pcshs.com/benefits/prescription/generic.html.
"History of the Generic Drug Industry" Barr Laboratories, www.barrlabs.com/drugpast.htm..
"Trend of the Month: More HMO’s Are Using Drug Formularies" Drug Benefit Trends 11(2): Pg.8-9, 1999, SCP Communications, Inc..
Yorke, Jeffrey "FDA Ensures Equivalence of Generic Drugs" FDA Consumer Special Report of New Drug Development in the United States January, 1995. www.kali.ucsf.edu/social/fda_reports/2098.217a.html.
Posted by gilbert on December 2, 2001, at 2:10:49
In reply to Brand Vs. Generic : The (Close as Possible) Truth!, posted by jay on December 1, 2001, at 14:10:29
Jay,
Thank you for the info.....I had already seen some of that on the FDA websites. The problem occurs not in the FDA tesing for ingredients or bioflav.........the problem comes in due to the fact the FDA does not have resources nor the employees to do follow up testing during long periods of time when generics are manufactured. Look at my post above and see Elizabeth's comment. Search down below there were similar complaints about Mylan about 2 months ago. As a matter of fact if you talk to a Mylan rep, which I did. She was a nurse who handeld complaints and would do phone interviews to determine the and diagnose the problems customers were having. She could not tell me the reinspection protocol that the FDA requires....how often, how much etc. She told me that the FDA could do random checks on the drugs to determine their continued fitness as a generic. I asked when the last time the FDA did one of those checks was......HMMMMM, she did not know. So all the approval process and checks and balances put into place to be able to produce generics are fine but afterwords is a different story.
As far as the cost savings part of your research goes, most of that will become ancient history. The generics for each subtype of drug are being bought out by larger companies so they can control most or all of the market place for certain types of meds. The politics of pharamcy contracts and health provider approvals leaves even more room for customer choice to be edged out. For instance right now I cannot get greenstone generic anywhere near my home all of the companies have switched away to Mylan.
As far as generics being as effeicent as the original......in a perfect world maybe. If the drug comppany has to cut costs to get the contract from the health provider or the large chain pharmacy.....call me skeptical but I think we will be the ones on the short end of the stick. Maybe just maybe the FDA will get lucky and on a random check will find low amounts of apralazom in their test batch......do you think the manufacturer goes out of business then.....no at worst they get fined and recall the batch.
I have had other generics in different medication classes all behave differently. I have never had a generic behave exactly as the real thing.....close but no cigar. Close does not bother me it is when it is not close that it does. So all of the FDA assurances in the world don't change a thing unless they are on the line in the manufacturing facilities on a regular basis.......which they aren't.
The bigger problem is that the pharmeceuticals are watched less than the comapany that sells you ground beef. At least meat companies have to have an on premise inspector. The FDA's job at this point in American history is damage control not to mention some of the corruption that has taken place shooting drugs thru phases so fast it would make your head spin.
So I appreciate your insight but in my real world the generics ahev flunked out about half the time. I have has some good generics....it's just hard to predict which time is gonna be which.
Gil
Posted by Collette1 on December 2, 2001, at 10:29:22
In reply to Jay FDA follow up inspections, posted by gilbert on December 2, 2001, at 2:10:49
The bottom line is that "consistant with" does NOT MEAN "IDENTICAL TO".
Gil, Thank you for verifying and repeating EVERTHING exactly the same as what I am experiencing here in rural Virginia! I too use CVS.
I am going to try a few mail-order companies where they send you 3 month supplies and see if they have better luck getting me either Greenstone or even Xanax itself. I am sick about this new Mylan Labs monopoly. Collette
Posted by gilbert on December 2, 2001, at 13:44:20
In reply to Re: Jay FDA follow up inspections, posted by Collette1 on December 2, 2001, at 10:29:22
Collete,
Ditto....I don't care much what is supposed to happen in a perfect manufacturing setting, or what hoops the FDA makes people jump through to be able to sell generics......what walks like half a duck, squawks like half a duck, must be half a duck.....and the Mylan was definitely an inferior product to anything I had been given which included Geneva, Greenstone and Xanax itself.
Gil
Posted by christophrejmc on December 4, 2001, at 21:37:12
In reply to Re: Jay FDA follow up inspections, posted by gilbert on December 2, 2001, at 13:44:20
I don't know where exactly in the metro area you are, but the last alprazolam generic I got here (Grosse Pointe, CVS + a few independent pharmacies) was Geneva. This was a few months ago, though...
Posted by gilbert on December 4, 2001, at 22:48:08
In reply to Re: Jay FDA follow up inspections » gilbert, posted by christophrejmc on December 4, 2001, at 21:37:12
Thanks Jay,
That isn not too far ffrom me I am on the west side. Although my doc wants me off the xanax now permantly.......he thinks it is causing sleep apnea........weird. Got a script for a beta blocker and am titating down over the next month.
Gil
Posted by Lindsay Rae on August 26, 2003, at 20:48:27
In reply to Re: Anyone else have a problem getting generic Xanax? » Pamela Lynn, posted by Collette1 on November 29, 2001, at 12:00:24
Hey folks, I'm new to this board but found this thread while doing a google search on the subject of Mylan Alprazolam strength when I realized I could no longer get the previous generic Xanax the pharmacies offered. This thread is two years old, so I'll totally understand if the previous posters are not available to comment, but I need to know if Mylan Alprazolam is in fact weaker than Upjohn Xanax or Greenstone Labs Alprazolam. I am needing to take at least twice the usual dosage, and it's not a tolerance issue since I've been taking them on and off for two years and have never needed more than .5mg at one time. I'm really scared and overly anxious about this, especially now that I see others had the same account up in NJ in November of 2001.
Any comments or findings would be greatly appreciated!
Chewing my nails in FL,
Lindsay> Collette,
> >
> > Hi! I live in Northern New Jersey and have been (for over a year now) been taking the generic form of Xanax (from Mylan-Alprazolam 0.5MG). Now, I have never, ever had the 'real' Xanax, nor has my label on my bottle ever said Greenstone Labs....BUT, I have always had great results with the generic form that I do take. I mean, I take it for anxiety and it does the trick for me.
> >
> > Actually, I just called my Pharmicist to ask him about this! He tells me that there is "absolutely no difference" between the Greenstone Labs that you mentioned and the Mylan (remember--'he'told me this). He told me that when they order generic of anything for the pharmacy that they use whatever the 'wholesaler' has in stock at the time of ordering. "HE" told me that ALL forms of Xanax-generic or not, ARE tested for potency, and that, in NJ at least, they have to pass the 'test' for potency or they don't market them.
> >
> > Like my shrink, I trust my Pharmiscist, and hold him in the highest regard. I was VERY satisfied with what he had to tell me regarding the generic Xanax that I take. I wanted to be sure I was getting as good as the reg./non-generic form of Xanax; I am now pleased and assured that what I take is doing it's job.
> >
> > P.L.
> > P.L.
> >
> > > As many of us recently learned, Greenstone Labs makes the most authentic generic Xanax (alprazolam). Now my pharmacist says they are "back-ordered" meaning that they have NO IDEA when or if they will get more in! I am wondering if this is really true or if they just don't want the bother of my wanting them to order a generic other than the one they want me to use..by Mylan labs. Collette
>
> We had a big discusiion about this around a month ago and most who WERE ALREADY taking the Greenstone labs version were VERY unhappy when Mylan was suddenly forced on them. Mylan labs may "work" but the timing of how it enters your system is quite different and if you have always used the Mylan version, you are probably OK with what it does for you. Those of us using the Greenstone version( which is made by the makers of Xanax) found a big difference in the strength and speed with which it works. Perhaps it will just require an adjustment period, but I would prefer to get the brand name at this point. Glad it works for you. Collette
>
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.