As a side note pharma companies sometimes get flustered by excipient manufacturers that change their manufacturing process without telling them. The trick is finding good and consistent suppliers, which can be tough for certain ingredients.

There were no noticeable changes because they didn’t have changes in suppliers or they didn’t change manufacturing locations or they didn’t change formulations that you were privy to. But the reality is the variability exists in both brand to generic- batch to batch.. There just is not a great deal of science in drug manufacturing but there is a great deal in drug development–hence the scale-up issues. And most drugs aren’t even made here anymore. Pfizer’s newest plants after their bloodletting in New Jersey, etc. are outside the US in “developing countries!” Genentech’s newest plant is in Singapore. Making Teva in India look positively cutting edge…

:/

Generic drugs are allowed to be considered bioequivalent to the innovator product. This gets interesting when it IS the innovator product (making the branded drug a generic because they no longer adhere to their own tighter In House Protocol). Branded drug makers are basically tossing the more complete science, under which they were scrutinized when they gained NDA approvals.
Honestly, if I were a chemist that worked hard to make a safe and effective product, I’d be insulted that my hard work had been reduced to a couple of blood draws to determine dissolution.

Bioequivalency does not mean that some drugs are exchangable. Here is why…

There may be the same amount of active ingredient in all of the products, but the excipients determine dissolution.
One dose studies to determine dissolution cannot begin to examine a product that requires titration. The result of those one dose studies are not even required to remain in tact, based on the loose FDA criteia.

If a product is made with a more dense form of lactose (for instance) it is going to be delivered more slowly. Consistency being a major concern in some medications, we cannot have people switching products, nor can we have drug makers changing the delivery of medications based on that loose FDA criteria for generic drugs (or branded generics) in drugs that require precise dosing.
We cannot have drug makers switching things like Magnesium Srearate from a bovine to a vegetable based product and expect the same result.

I don’t belong to any group to promote the pharmaceutical industry. In fact, I am disgusted with their willingness to reduce the quality of their medications without consideration for the consumer.
I do understand their need to be able to compete when their product goes off patent or off an insurers list of allowed branded medications.

I now take a generic (not Pfizers), which is different from lot to lot. I have to titrate every few months and it is sometimes extremely difficult. Before Pfizer reduced the quality of Dilantin there were no horribly noticable changes in their medication. Their In House Protocol (or that of PD) was much tighter. This article is a MUST READ…
http://www.medscape.com/viewarticle/414647

Keep in mind that the article relates to Dilantin as it was before the reformulation.

Maybe this address to FDA by a highly accredited Neuro is more clear…
http://www.fda.gov/ohrms/dockets/ac/99/slides/3547s1i.pdf

Sorry I went long, again, but this is so simple that it has become difficult.

http://www.bloomberg.com/apps/news?pid=20601124&sid=aQPqqyXr2lYU&refer=home

The reality is both the brand and the generic have the same scale-up issues from laboratory to manufacturing. There is a dearth of publicly available good manufacturing science… And the variability that your physician speaks of is the same as the variability the BRAND has batch to batch. Without it, a drug would never be approved. Everyone is within the same monograph when the generics come to market so there is not the issues beyond the binders and fillers.

Not every drug works for every body and one day personalized medicine may tell us why but it could lie in the binders and fillers for both generic and brand. Or it could lie in the fact that drugs are over-hyped to down play side effects.

I have in no way discounted that branded meds may work better than some generics due to formulation. And I could probably find people that the inverse is also true. I know when we ran clinicals next to a branded product, we actually had better efficacy and bioavailability from reformulating.

Fraggle, do you have experience developing and manufacturing of pharmaceuticals or are you basing your knowledge on what other people tell you? Is your knowledge of medicine is second hand? Well I have a friend that knows a friend at the FDA that says your Doc is full of it.

Pumpkin….you missed the entire point….a branded medication can have the same differences! There are branded meds that have a spec difference for CU at +/-25%…..and it meets specification. And I used the word “typically” since the FDA has the authority to require that the specs are tighter….thus not making the specs exactly the same. So I use the word typically since it is not 100% of the time that specs match for branded vs. generic.

Say what you say, but it is what it is.

Take your views up with my doctors. Don’t waste any more of my time. This is a no brainer, moot issue.

You failed to mention that the FDA criteria for generics allows for a wide +/- swing in a drug that requires precise dosing and lengthy titration periods. Allowing for dangerous changes from lot to lot.

But before you go all ‘No Generics’ you may want to read this article, as branded drugs are allowed that same loose criteria upon reformulation (according to CDER). Without warning to the consumers, and despite doctors writing DAW or no substitutions on your prescriptions. In fact, a pharmacist is required to fill those prescriptions with the altered branded product based on the DAW.

http://www.pharmalot.com/2008/05/a-new-version-of-dilantin-is-giving-pfizer-fits/

There is a group that carries Ed’s article on them at all times, for their safety, in case of emergency. He deserves an award. Someone needed to inform people.

Yeah, typically….. Typically, it’s not warm in November…. Would you want your child to take a seizure preventative, brand name drug, then suddenly switch to a generic that could legally be 20% less potent than the brand name drug he or she has been on for a year?

Typically is a word without a home with regard to this issue.

And keep your damn safety glasses on!

Give it a rest. My own doctors who know insiders in the FDA admittedly purport this to be the case. And you know for sure when you take a meducation for say, migraines, and the brand name works far better than the generics. Some generic companies have purchased expired medication from the original source, put a fresh coat of paint on it, and give it’s stamp of approval.

And I’ve seen how CU tests can be twisted without tractability.

Put your time to a better topic.