Drug Package Insert Regulations


The Times this morning offers this revealing story about the FDA’s new drug package insert regulations.

There is lots here for the legal blawgosphere to chew on. Administrative law profs will be interested in claims about the pre-emptive effect of the regulation’s preamble. Behavioral researchers will like the discussion of information overload. And, needless to say, food law folks will wonder if they are next.

But I’m interested in a detour around halfway through the story, where the author notes (and I’m going to take his word for it) that:

But the rule does not address the information sheets routinely provided to patients by pharmacists. These sheets are lightly regulated and often fail to include important drug warnings.

Here’s my (perhaps silly) question. What economic explanation is there for the “fail[ure] to include important drug warnings”? Even if consumers don’t want this information,* why don’t drug companies want to marginally reduce their liability costs? Perhaps they are more interested in making “extra” profits on off-label use (which could be deterred by pharmacy information sheets) than they are concerned about reducing accident costs (which might be relatively fixed). But perhaps I haven’t thought about this hard enough. Does anyone else have an idea?

* I’m skeptical, that that is a topic for another post.

You may also like...

1 Response

  1. Ken Arromdee says:

    Drug companies want to reduce their liability costs (which may mean giving warnings), but they also want to make the drug look good (which may mean omitting warnings). These are conflicting goals. One way to reconcile these goals is to give warnings but to do so in the least prominent way possible. Entirely leaving warnings out of some types of communication may serve this goal as long as the consumer can be expected to receive the warning somehow.