Psychopharmacology: Brand versus Generic
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I found some pretty ridiculous answers to my questions about the extent of the FDAs oversight of generic drug manufacturing, and all from FDA or other government sources:
http://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm279676.htm
^The FDA does not test generic drugs. They require pharmaceutical companies to submit their own findings about their formulations. As far as I can tell, the FDA never tests a batch of a prescription drug.
http://oig.hhs.gov/oei/reports/oei-01-13-00600.pdf
^The title of this one is funny, considering that it explains how the FDA only inspects facilities, not drugs (it appears that no one from the FDA does any chemical analysis or clinical studies on drugs. Ever. This report also states that the FDA will "request" records from manufacturers in lieu of inspections.
http://www.fda.gov/Drugs/Developmen...ufacturingPracticescGMPforDrugs/ucm072062.htm
^The FDA answers a bunch of questions in vague terms. In answer to "Why doesn't FDA inspect all pharmaceutical manufacturers at least every two years?" they explain that this would be expensive because there is an increasing number of manufacturers and many are in foreign companies. WHAT?! At least every two years-- it doesn't?!
I don't understand why the FDA doesn't respond to its lack of funding and inability to regulate by LIMITING the amount of approvals for generic drugs. You know, to make sure it can do its job.
Considering the FDAs ONLY response to "how often does the FDA inspect food manufacturing facilities?" is "ROUTINELY" (not one number mentioned), it doesn't seem odd that its efficacy of oversight is limited. I don't think I need to go into how the FDAs regulation of Big Agriculture is pathetic and blatantly moviated by a revolving door of lobbyists and regulators.
Oh, and the same "revolving door" of lobbyosts and regulators exists between phamesuetical companies and the FDA. The same people who regulate drugs worked for drug companies, and vise versa. The fact that the FDA keeps approving medications that it doesn't have the resources (by its own admission) to regulate doesn't seem so strange anymore.
I could cite maybe 10 sources I spent a while looking at, with specific examples of people using this "revolving door," and of how drug manufacturers blatantly buy FDA drug approval (for example, the FDA drug approval process is not funded by taxpayers, but by the drug industry. I didn't know that.) But it's a real easy search: "FDA pharmaceutical lobbyists."
So the argument for generic drugs equalling the original brand formulations is: information reported about the efficacy of drugs by the FDA (which never, ever analyzes a drug itself, but relies on the word of manufacturers who spend billions of dollars on lobbying, which can't even inspect drug manufacturing facilities once every two years, and allows the companies' own reports to replace inspections) is reliable. And when the FDA analyzes its own information after a few years, that's reliable too. I don't know how most of the information regarding the variance of bioequivilency mentioned in this thread (given that most of these numbers came from the FDA, which did not actually find those numbers itself, but took their pharma buddies' word for it) could be considered truthful.
http://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm279676.htm
^The FDA does not test generic drugs. They require pharmaceutical companies to submit their own findings about their formulations. As far as I can tell, the FDA never tests a batch of a prescription drug.
http://oig.hhs.gov/oei/reports/oei-01-13-00600.pdf
^The title of this one is funny, considering that it explains how the FDA only inspects facilities, not drugs (it appears that no one from the FDA does any chemical analysis or clinical studies on drugs. Ever. This report also states that the FDA will "request" records from manufacturers in lieu of inspections.
http://www.fda.gov/Drugs/Developmen...ufacturingPracticescGMPforDrugs/ucm072062.htm
^The FDA answers a bunch of questions in vague terms. In answer to "Why doesn't FDA inspect all pharmaceutical manufacturers at least every two years?" they explain that this would be expensive because there is an increasing number of manufacturers and many are in foreign companies. WHAT?! At least every two years-- it doesn't?!
I don't understand why the FDA doesn't respond to its lack of funding and inability to regulate by LIMITING the amount of approvals for generic drugs. You know, to make sure it can do its job.
Considering the FDAs ONLY response to "how often does the FDA inspect food manufacturing facilities?" is "ROUTINELY" (not one number mentioned), it doesn't seem odd that its efficacy of oversight is limited. I don't think I need to go into how the FDAs regulation of Big Agriculture is pathetic and blatantly moviated by a revolving door of lobbyists and regulators.
Oh, and the same "revolving door" of lobbyosts and regulators exists between phamesuetical companies and the FDA. The same people who regulate drugs worked for drug companies, and vise versa. The fact that the FDA keeps approving medications that it doesn't have the resources (by its own admission) to regulate doesn't seem so strange anymore.
I could cite maybe 10 sources I spent a while looking at, with specific examples of people using this "revolving door," and of how drug manufacturers blatantly buy FDA drug approval (for example, the FDA drug approval process is not funded by taxpayers, but by the drug industry. I didn't know that.) But it's a real easy search: "FDA pharmaceutical lobbyists."
So the argument for generic drugs equalling the original brand formulations is: information reported about the efficacy of drugs by the FDA (which never, ever analyzes a drug itself, but relies on the word of manufacturers who spend billions of dollars on lobbying, which can't even inspect drug manufacturing facilities once every two years, and allows the companies' own reports to replace inspections) is reliable. And when the FDA analyzes its own information after a few years, that's reliable too. I don't know how most of the information regarding the variance of bioequivilency mentioned in this thread (given that most of these numbers came from the FDA, which did not actually find those numbers itself, but took their pharma buddies' word for it) could be considered truthful.
I don't understand. No one considers stimulants as having a narrow therapeutic index, but some practitioners think minor dosage changes have major effects? Aren't these opposite ideas?
As I mentioned before, I've never noticed a difference between generic drugs and brand (that's 30 years of experience) UNTIL I began being treated for ADHD. I was most certainly not going into treatment with a preference for brand.
Everything I have read about stimulant dosing says that small variance in dose can have a major impact, sometimes meaning the difference between making you focused and alert, or jittery/hyper-focused/"tweaky," or even sleepy. Since dopamine can both increase focus/energy AND promote sleep, a slight variance in a medication that affects dopamine receptors having completely different effects makes sense.
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Sounds like you're just looking for an issue
The FDA already doesn't rate them as AB generics and they can't be used to substitute for Concerta.
The minuscule difference in dose between a generic and brand in amphetamine salts is unlikely to have a major impact on someone. If its that big of a deal to you, get the authorized generic.
I don't have time to answer all of your misinformation/misconceptions, but I will answer this one. Your stomach is acidic. The rate a drug breaks down is going to depend both on the specific drug and how acid or basic the liquid is. Your mouth is not as acidic as your stomach, neither is water, so the rate they break down in your mouth, will be different from the rate a pill breaks down in a glass of water, and both have nothing to do with the rate they break down in the stomach, which is quite acidic.
Drugs which are designed to be time-released do so by different inactive ingredients then you would find in a regular release drug or structuring the drug differently (like putting an inactive layer around the drug, or putting the drug in a wax matrix) . It's not like adding more or less lactose to a drug is going to affect its bioavailability, which seems to be what you are implying.
There is no logical reason why generic Adderall would work differently for you from the brand. But its a free country, and people always have the choice between brand and generic (at least, as long as they are willing to pay for the brand.) If the brand works better for you, then you shouldn't have a problem paying more for it. Your suggestion that the FDA should limit generics, and thereby limit other people's choices is ridiculous. Why should other people have to pay for the high cost of a brand, just because you don't like the generic? For the vast majority of patients, the generic form of Adderall works just as well as the brand. Rather than being to lax in improving drugs, the FDA has rightly been criticized over the years, for dragging out the approval process far longer than it needs to be.
The FDA does have a thankless job, with everyone thinking you are either too strict or not strict enough.
Every generic application has a $500,000 fee associated with it. Your suggestion would cut funding. Google PDUFA to learn more.
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If this entire "brand is superior to generic" movement were evidence based people might listen, but it's not. Meanwhile pharmacies around the country have to keep brand name Zoloft, Adderall and Xanax because people don't "feel the same" when they take the generic. Where are the people who swear by brand name Keflex? If the regulations aren't strict enough, why isn't the IDSA calling for removal of generic antimicrobials based on inferior of effectiveness?
I've seen people swear the brand authorized generics of those two don't work as well even though they are literally the same thing with slightly different cosmetic imprints/lettering. That's how I know the power of the nocebo.
Note how the generic never seems to work better.
Yeah, seems to me that sub-potent Keflex would do much more harm than sub-potent Zoloft (by increasing antibiotic resistance), but funny how that doesn't seem to be a problem.
A few people have told me the oval shaped Percocet works better than the round tablets.
