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It Ain’t Necessarily So

Common Misconceptions About Brand Name and Generic Drugs

By Brassmonkey

 

For many years there have been several rumors circulating about the quality of both brand name and generic drugs. Their relationship to each other and whether you actually get what you pay for. The two major rumors are about the quality of the product: saying the generic products are of lesser quality and inconsistent strength and that both products are not mixed. I’ll start right out by saying that both of these rumors are false.

 

What are Generic Drugs?

 

According to the US FDA:

A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics. https://www.fda.gov/drugs/generic-drugs/generic-drug-facts

 

The whole idea of generic drugs started many years ago to help combat the high cost of medications.  Large drug companies own the patents on the drugs they develop and roll the development costs into their prices.  Which makes sense until they have recouped their costs and start making huge profits. (I am not opening this thread up to discussions Big Pharma price gouging).  Once the patent expires the US government decided that the drugs should be made available at a lower cost and to do so they would let other companies make the drug as long as it was exactly the same as the original. This meant with a lot of resistance from the big Drug Manufacturers, but that’s not what we are discussing here.

 

So that the new medication could be differentiated from the old, they were to be manufactured with certain differences. They had to be different in five ways: Shape, Color, Packaging, Flavor and Inactive Ingredients (fillers). Everything else about the medication, Quality, Dosage, Strength and Route of Administration, had to be exactly the same as the original.

 

All this means is, the only difference between Brand Name drugs and Generics is the type of fillers that are used. The shape and color of a medication are irrelevant because they have no bearing on how effective the medication is.

 

There are a wide variety of materials that can be used for fillers.  We will be talking about tablets and capsules because they are the most common form for psychotropic drugs. Liquid forms of the drugs are a totally different topic, but still fall under the same guidelines for manufacture. Of all the fillers available three are the most common, Starch, Calcium Salts and Milk Sugar.

 

Each filler has its own characteristics, but the factor they have in common is that they are inexpensive. For the most part there is very little difference between them.  They have different solubility rates, buffering profiles and very minor effects on the bioavailability of active ingredients. For a few people going through ADWD, these differences can be a problem. Which is why we recommend doing a cross taper when changing from one manufacturer to another or when changing from brand name to generic. It is also why some people do well on brand name and have problems with generic medications. Other than this, by law, generic drugs are exactly the same as brand name.

 

The common rumor is that generic drugs are allowed to have up to 20% less active ingredient than brand name, and sometimes can have no active ingredient at all. This rumor started many years ago when it was found that a small, unlicensed, maker of gray market drugs was found to be making tablets with little or no active ingredient in them. The manufacturer was fined, stopped production and the tablets were removed from the market.

 

The rumor, however, has circulated for many years and is still causing problems.  It’s not to say that counterfeit drugs won’t show up, but if reputable medications are purchased from a well documented source there should be no problems with it.

 

There can be small variations in the amount of active ingredient contained in the medications.  This is due to manufacturing tolerances and is closely regulated by both the manufacturing company and government agencies.  The regulations state that the amount of active ingredient can vary up to 3%. This amount can be found in a minority of lower quality generics, but brand name manufacturers and the higher quality generics hold themselves to a much higher standard. The brand name manufactures use 0.3% as a standard.  When the Active Ingredient Concentration of a tablet is calculated using the 0.3% figure the difference between tablets is so small that it will not cause a noticeable difference when we go to weigh out our daily dose.

 

It’s All in the Mix:

 

One of the biggest fears regarding tapering we encounter here at SA is that the active ingredients in a medication are not evenly distributed throughout the fillers. This leads to people thinking that if they are taking a small portion of a tablet or of the powder in a capsule that they will not be getting the “full dose” that they are expecting. This assumption is totally wrong.

 

The manufacturing of drugs in one of the most regulated processes in the world and is overseen by the coordinated effort of a number of international organizations. These include the Current Good Manufacturing Practice regulations enforced by the FDA, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, the World Health Organization, the Pan American Network on Drug Regulatory Harmonization (PANDRH), Internation Society for Pharmaceutical Engineering (ISPE), European Directorate for the Quality of Medicines and Healthcare (EDQM) and several others.

 

Each of these organizations has an extensive set of regulation on the manufacturing processes involved in making medications and has the power to enforce those regulations.  They also coordinate freely with each other to maintain unity in those processes and regulations. One of the foundations on which these regulations are based ins the Essential Standards for Pharmaceutical Manufacturing written by the American Society for Testing and Materials. Another document containing links to all the US federal guidelines for manufacture, testing and marketing drugs is here: https://www.dshs.state.tx.us/drugs/federal-regulations.aspx

 

What it comes down to is that, even though we here at SA don’t like what these products have done to us, they are some of the best products produced in the world when it comes to quality.

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bottlehalffull

My understanding was that the chemical synthesis is also covered by the patent, and generics manufacturers have to use a different synthesis pathway. Which in theory is fine because the different syntheses end at the same point, but can result in different by-products in the finished product because 100% purity is really hard to get to. Is this also a myth?

 

I've recently had the pleasant surprise of moving to another country and the local generic xanax doesn't give me the dysphoria the stuff in the US gave me. It's supposedly the same chemical and dose......

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bottlehalffull

Sort of found the answer to my own question...

What standards must generic medicines meet to receive FDA approval?

... must show the generic medicine is equivalent to the brand in the following ways:

  • The inactive ingredients of the medicine are acceptable.
    • Some differences, which must be shown to have no effect on how the medicine functions, are allowed between the generic and the brand-name version.
    • Generic drug companies must submit evidence that all the ingredients used in their products are acceptable, and FDA must review that evidence.

from https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers
 

With people that are hypersensitive to chemicals, like many of the people on this forum seem to be, "acceptable" differences in inactive ingredients may be palpable to them. Maybe in a normal population, there is no difference.

 

And also here's a huuuuuge dataset of anecdotes showing what can happen even with the requirement that a drug company provides evidence that their version of the drug is "bioequivalent":

https://crackdownpod.com/podcast/episode-2-change-intolerance/

To summarize, in British Columbia, the government switched to using a specific brand of methadone (Methadose) for opiate addicted patients, instead of the previous compounded version. It was supposedly bioequivalent, but the same dose did not seem to last in the body for as long, causing people to go into withdrawal before the next dose. The bioequivalence study cited by the manufacturer was only done on 18 people, which didn't represent the patient group that it ended up being prescribed to for their methadone maintenance therapy. The exact cause is still to be determined, it may turn out to be one of the more rare bad manufacturing practices cases. But still five years later there are plenty of people, from doctors to lawmakers, that are convinced that it's all in the patients' heads. I am unsure of whether there is an official investigation underway yet. If you prefer reading, there's a transcript linked at the bottom of the episode summary. Talking about the bioequivalence study starts around page 16.

 

 

All that being said, I still trust generics! But if you switch brands and notice a difference, there is still at least some chance that it's not all in your head.

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Hibari

@brassmonkey  

 

Thank you for this post.  I have been one of those people who has been overly focused lately on whether the medication is fully distributed through my Clonzapam pill.   I am dry cutting and use two scales and a nail file to get the doses I need.  I do this after I break the pill in half along the scored part of the tablet and then break that half in quarters.   I then weigh what I need to very carefully.  

 

I've had a rough time lately and have considered switching to crushing my pills but I'm not completely settled on that choice.    I think my taper is rocky right now because of nature of moving lower.  I am tapering slowly and with small cuts.   I have had small windows and days that are okay, which is a good sign.  The days after a cut are when I question everything.  

 

Reading this today really eased my mind and even if I do switch over at some point, you post has made me feel calmer. 

 

Thank you. 

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