Tuesday, November 26, 2013

FDA Proposes Rule To Allow Generic Drugmakers To Change Labeling

Back in August I posted that the FDA was considering adopting new regulations that would allow (and presumably encourage) generic drug manufacturers to add or update the safety warnings on their products.  At the time, they were required to have exactly the same warnings as the name brand products.  A new rule would allow manufacturers of generics to decide whether to use a different warning on their products.  At the time of the proposal, some liked the idea (here), others did not (here).

Earlier this month, Pharmalot reported that the FDA has in fact proposed a new rule. The proposed rule will allow generic drugmakers to update labeling with new safety information before an FDA review of the change. The agency would then evaluate whether the proposed change is justified and make an approval decision on the generic drug labeling change and the corresponding brand drug labeling change at the same time.

As expected, the rule is controversial.  Some agree that the new approach is a good idea (here, for example); others argue it is a bad idea (here and here, for example).  For more comments see here.

One thing that bothers me about the discussion is that it seems to concentrate on whether the new rule will lead to more litigation, when I think the guiding concern should be whether it leads to more safety to consumers.  The arguments based on the issue of litigation are based on the notion that litigation is per se a bad thing, forgetting that (a) not all litigation is unjustified and (b) sometimes the result of litigation is a safer product.