Generics; The Untold Story


Rarely do I come across a pharmacy topic that stirs as much emotion as does the discussion of generic medications.  This is a subject that both patients and physicians are passionate about.   Quite often, firm opinions are based on anecdotal, rather than proven data.    When a medication has been approved by the FDA for generic substitution, it has met rigorous standards with regards to bioequivalence, strength, quality, potency, identity and purity. 

See this great page from the FDA about frequently asked questions regarding generic medications.
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm

There is a common miss-conception that a generic medication may be anywhere from 25% more potent to 20% less potent than its brand name equivalent.  This miss-conception comes from an interpretation of the methods of how medications are studied for FDA approval. 

The FDA states that a generic drug is considered bioequivalent to its associated brand name medication if the 90% confidence interval of the average or mean of the area under the curve vs. concentration curve and the maximum concentration of the generic product is within 80% to 125% of the brand product. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf

OK...so what the heck does that mean?  What happens is that someone will read that statement and the only piece of information they see is the 80% to 125% and from that tiny piece of information they falsely conclude that there is the potential for a 45% variance in generic medications. Confidence interval testing is a form of statistical analysis that demands a superior knowledge of advanced statistics. 

The FDA studied 12 years of generic confidence interval testing data, from 1996 to 2007.  They found that, on average, there was no more than 3.5% difference between the brand name medication and the generic medication.  This difference of 3.5% would be the same whether it was one batch of brand name tested against another batch of the same brand name, or tested against the approved generic equivalent.   http://www.ncbi.nlm.nih.gov/pubmed/19776300

It is interesting to note that many "generic" medications are actually made by the exact same company that makes the brand name medication.  It is easy for them to do this because they do not need to do any bioequivalence testing before they package the medication; it is the same medication.  The only difference is that they package the medication in a generic container and sell the medication for a significantly reduced price. 

Please realize, cheaper cost does not equate to cheaper quality.  Generic companies can sell their medication for less money because they do not need to advertise or go through the process or repeating the costly clinical trials that the brand name drug manufacturer needed to do. 

Please do not get me wrong, I believe that the company that produces the brand name medication has the right to make a profit from all of the expenses and resources they put into testing and bringing to market their product; however, after the patent has expired, generic is the way to go.  In 2010 alone, generic medications saved over $158 BILLION dollars.  When it comes to cutting health care costs, there are very few reasons why a patient would need a brand name product when there is a FDA approved generic equivalent product available.
http://www.gphaonline.org/media/press-releases/2011/new-study-finds-use-generic-prescription-drugs-saved-consumers-and-us-heal

We have talked extensively about the fact that generic drugs are equivalent to their brand name counterparts.  Physicians and patients still raise the question as to whether generic medications are clinically inferior to their brand name counterparts.  An evaluation of 38 clinical trials showed clearly that there was no difference in clinical outcome between the generic and brand name medications. 
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2713758/

To help answer any more questions about generic medications, please review this page discussing facts about generic drugs.  http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm167991.htm

Thanks
Steve
www.AudibleRx.com

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