Thoughts on Global Medical Affairs
As I discussed here, a recent ruling by the Second Circuit Appeals Court provided a new legal foundation for off-label promotion on free-speech grounds. As the law currently stands in the Second Circuit, as long as the speech is “truthful” it is protected by the First Amendment and thus open to anyone. Sales reps and MSLs in Ney York, Conn. and Vermont have one less thing to worry about.
Many, myself included, assumed that the FDA would ask for a re-hearing in the Second Circuit, but that date has come and gone without such a request. You can read about it here.
At this point the FDA can go two ways – they can ignore the ruling and let it stand for the Second Circuit, which may result in a set of haphazard interpretations over time as different Circuit Counts rule differently, or it can appeal the ruling the Supreme Count. Assuming the Supreme Court would agree to hear the case, appealing it to them could result in a ruling that the Second Circuit ruling should be the law of the land.
So the FDA is left with a choice – take what it has and accept that the off-label promotion rules may gradually crumble or risk those rules completely by appealing to the Supremes. They have until mid-March (or until mid-May if they wish to extend their timeline) to make that decision. I will continue to fill you in when I learn more – watch this space!!