A new Fortune article “Are Generics Really the Same as Branded Drugs?” (1/14/13) sets a dangerous tone for something that has become a standard across the pharmaceutical industry. This is either:
(b) a dangerous perspective which will only further activate the conspiracy theory consumers and clinicians.
For facts on generics, I would point you to the FDA website. I posted some of their slides years ago on SlideShare which I put below along with their latest infographic.
The article in Fortune focuses on a case regarding an anti-depressant called Wellbutrin and its generic counterpart. The article goes on to point out that the active ingredients in the generic (compared to the brand) can vary from 80% to 125%. (I think a good more detailed explanation of this is available here).
But, the author goes on to point out the risks associated with the fillers (or inactive ingredients) and talks about the issue of NTI (Narrow Therapeutic Index) drugs that no one substitutes for anyways.
One big thing that I was always taught was to understand that the difference in active ingredients between brands and generics was similar to the differences in different lots of the same brand drug. And, given the fact that traditionally, 50% of generic drugs were made by the brand manufacturers, it would seem difficult to believe that they were simply throwing caution to the wind by producing substandard product.
I would hope that Express Scripts, CVS Caremark, Walgreens, PCMA, and many other groups will come out strongly to address this article. This is the type of article that could be a significant setback to the generic industry which has proven itself under lots of scrutiny over the years to save money and have very few negative impacts with the FDA’s scrutiny.
George: I appreciate that you are pointing folks to the FDA website for accurate information. This article from cnn money is doing its best to discredit all of the explaining we do at the pharmacy counter on a daily basis.
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, “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.”
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.
Also, many NTI products are substituted, as long as the alternate (Generic) is A-rated by the FDA. Many are NTI products are prescribed by the generic name.
The author (Katherine Eban) wrote a similar article in 2009 for SELF magazine about Wellbutrin. What’s new?
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