Both patients and physicians have strong opinions about the equivalence of generic medications. Opinions are regularly based upon anecdotal, rather than proven data. The FDA imposes rigorous standards about bioequivalence, strength, potency, quality, identity, and purity prior to its approval of a medication for generic substitution.
There is a common misconception 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 versus concentration curve and the maximum concentration of the generic product is within 80% to 125% of the brand product.
That all sounds well and technical; however, I have been practicing pharmacy for more than 25 years and I still have a difficult time wrapping my head around that statement. Regularly, what will happen is that someone will read that statement and the only piece of information they see is the 80% to 125%. From that piece of information they conclude, falsely I might add, 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.
Please be aware, many generic medications are actually made by the exact same company that makes the brand name medication. This 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.
When a medication has a cheaper cost it does not necessarily equate to cheaper quality. Generic companies are able to sell their medication for less money because they do not need to go through the process or repeating the costly clinical trials that the brand name drug manufacturer did. Furthermore, a generic medication does not need to be advertised, so advertising costs are significantly reduced.
I truly 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 an FDA approved generic equivalent product available.
With all the information available, patients, and surprisingly, physicians, still raise the concern that generic medications equate to sub-standard therapy. An evaluation of 38 clinical trials showed clearly that there was no difference in clinical outcome between the generic and brand name medications.
Become educated about generic medications so you may help educate others that using a prescribed generic medication is not sub-standard treatment; rather, it is cost effective therapy.
If you still have questions, visit the frequently asked questions page at the FDA website.
Dr. Steve Leuck is currently a community pharmacist in a hospital out-patient pharmacy, where he educates and motivates patients to participate in their own pharmaceutical care. He is also owner of AudibleRxTM where OBRA 90 based Medication Specific Counseling SessionsTM are available in audio format.
This medication summary is for information only and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.
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