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Beware the Generic Drug…Again
A year ago on this show (November 27, 2011) we focused on the legal dangers of generic drugs after the US Supreme Court’s absurd ruling which gave absolute immunity to the manufacturers of dangerous generic drugs. The basis of the court’s decision was that generic drug manufacturers are only copying the dangerous brand name drug. How about giving immunity to serial killers as long as they are only copying the work of a previous serial killer? Pretty absurd. This ruling makes about as much sense as investing in Arizona coastal real estate.
But now we have to pay attention not just to the legal dangers of generics, but the medical ones as well. For years generic drug manufacturers have boasted that their drugs are EXACTLY the same as the brand name. To “prove” it, such companies point to the fact that the FDA requires them to use the same chemical formulation (or recipe) as the brand name drug. Well, this always made me suspect because it takes more than a recipe to get it the same. Many times I have used grandma’s cookie recipe—and followed it completely—but the cookies still weren’t like grandma’s. Now there is support for my hypothesis.
The New York Times recently reported that one particular generic drug was found not to act in the same way as its brand name counterpart. In response, the director of the FDA’s office of generic drugs said the report “has actually prompted a change in [the FDA’s] policy,” and that the agency would look more closely at the techniques used by generic manufacturers. How are they going to do this? Position “recipe monitors” in every laboratory? And how effective will they be? Without grandma in the kitchen herself, the cookie baking process just isn’t the same. To do otherwise is like directing a brain surgery via Morse code.
If you’ve got the answer, let me know. But for now, I have a headache. I think I’ll go take some Motrin…no, Wal-buprofin…argh! Which is it?
For the November 27, 2011 episode of the Wyatt Wright Show dealing with generics, go here:
http://www.wyattwrightshow.com/podcast/generic-drug-manufacturer-immunity-part-1/
For the New York Times Article, go here:
http://www.nytimes.com/2012/11/01/business/fda-increases-scrutiny-of-some-generic-drugs.html?_r=0