FDA’s Brief in Par: The Gift that Keeps on Giving

By Jeffrey K. Shapiro –

We previously discussed the government’s brief in the Par case in the context of what it says about FDA’s draft Research Use Only guidance.  However, the government’s brief in Par is worth examining from another angle.  (Note:  the Par case involves promotion of a drug, but the discussion below applies equally to medical device promotion.)

Background.  Par sued for declaratory relief, seeking a ruling that FDA’s regulations prevent truthful and non misleading speech about the approved use of the drug Megace ES. (see our previous post here).  The drug Megace ES is approved to treat wasting in AIDS patients.  Par alleges that it wishes to speak about this approved use to physicians in long term care and oncology settings, but fears prosecution under FDA’s regulations.  The drug has not been approved to treat wasting in these settings.  Par alleges that the chilling of its truthful and non-misleading speech caused by FDA’s regulatory activities violates the First Amendment.

On Label Promotion in An Off-Label Setting.  The government contends that Par’s complaint does not present a ripe case or controversy because FDA’s longstanding application of its regulations would not prohibit the proposed conduct.  The government emphatically argues that FDA’s regulations do not prohibit the dissemination of on label information about a drug in an off label setting.  In particular, according to the government, the proposed speech would not establish an unapproved new intended use.  (Gov’t brief, pages 15-19.)

The government ridicules Par’s fear of prosecution as self inflicted and unnecessary, and even based upon a “fabricated” reading of FDA’s regulations.  Of course, in reality, there has been widespread uncertainty whether FDA might find that dissemination of on label information about a drug’s use in an off label setting creates an unapproved new intended use.  This clarification from the government – if it truly represents FDA policy – is very welcome.

Of course, the clarification comes with a major caveat.  The government indicates in its brief that there would never be a prosecution exclusively based upon on label speech about a drug in an off label setting, but that such speech could be cited as one element of an overall scheme and practice to promote an off label use.