Thursday, June 23, 2011

Supreme Court rejects generic drug labeling suits

Today the Supreme Court ruled that generic manufacturers cannot be sued because they did not provide adequate labeling warning about side effects. This means that the generic drug does have to warn patients about side effects on its label when the branded drug doesn't.

The generic drug manufacturers argued that US law requires them to have the same label as the brand-name equivalent.

I have mixed feelings about this. I am not a big fan of the constant law suits we see, but at the same time I think that generic drug manufacturers have their own responsibilities for their products beyond the responsibilities of the branded drug maker.

For one thing, generic drugs are not necessarily identical to their branded equivalent. They are very close but not exactly the same. Generics are made by different manufacturers using different processes and sometimes the active ingredient strength is slightly different. We also see enough data where patients say that generics perform differently than brand-named drugs. So the generic could be slightly different and it could cause its own side effect. To unilaterally say that is not possible, doesn't seem completely thought-through IMHO.

Also, generics are usually on the market after a branded drug goes off patent and for a long time afterwards. So they may end up getting used longer. And as more drugs go generic, more information could surface about the generic drug before it surfaces about the branded drug.

So I am definitely leaning toward this not being a good idea. I see this issue resurfacing and unfortunately, not under the best circumstances.

No comments:

Post a Comment