~By Greg Zangari
As I was browsing Facebook today, my friend Sarah posted a recent article from Forbes magazine regarding a generic drug being pulled from the market (Thanks Sarah!). I worked in the pharma service sector for nearly 20 years in both academia and at two of the biggest Clinical Research Organizations (companies that pharma pays to run clinical drug trials on their behalf) and after knowing what I know now and seeing what I saw, I am so glad that I’m never going to work in that industry ever again.
This Forbes article discusses how the FDA does not test generic medications properly. In this case, they had bioequivalence data (data which shows the generic drug supplies “a similar” but not exact dose of the brand name drug) for the 150mg dosage, but not for the 300mg dose. The FDA only extrapolates the data to see if the higher dose generic will be safe and effective – they don’t actually test the pills themselves to see if this is true. Apparently, now because they found this issue, FDA is going to change the way they approve generic dosages which haven’t been lab tested.
Although several other companies make this generic, the drug we’re talking about is the 300mg dosage of Wellbutrin XL, an antidepressant, manufactured by Impax and marketed by Teva and approved in 2006.
“Almost immediately, the FDA started receiving reports from patients that claimed the 300mg dose was being associated with side effects and reduced efficacy.”
Patients reported directly to FDA that they thought these pills were ineffective, for years before anyone at FDA did anything about it. Once they had the data, FDA waited two months to release it which happened this past October.
“When the FDA issued its press release on October 3rd, it said that the FDA made a mistake in that it had taken the data for the 150mg version.  Since that dosage had worked fine, the FDA just assumed that the 300mg dosage would work.  I am not joking – they indicated that this case caused them to change the way they do things.  They approved the drugs by extrapolating the data for the 150mg, assuming the 300mg works the same.”
So now that FDA is going to fix this apparent “hole” I have to wonder, will this only be done going forward? Or, will the FDA do this retrospectively for all generic drugs on the market which meet this criteria?
“How many patients who were not adequately treated on the 150mg dose were put on the 300mg only to see their symptoms get worse because the generic did not work as promised?  How many patients, doctors, and their families thought that this was simply a further deterioration of a patient’s condition and mental state? How many parents had to worry about their children when their anti-depressant seemed to stop working?  How many people committed suicide taking a generic antidepressant that did not work?”
I also have to wonder if the generic drug manufacturers knew about this “hole” in FDA’s generic drug approval process, knew that this new dose of Wellbutrin wouldn’t be physically tested, then purposely did not put the correct amount of the active compound in the 300mg dosage of the drug. Would a generic supplier purposely do that? One has to wonder.
See the full article here: http://www.forbes.com/sites/davidmaris/2012/10/10/fda-recall-points-to-serious-problems-at-the-fda/

© 2012 – 2013, shiftingtimesarehere. ™ Wendy & Greg Zangari, All rights reserved. Permission is granted to copy and redistribute these articles on the condition that the content remains complete and in tact, full credit is given to the author(s), and that it is distributed freely.

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