A New Policy on Off-Label Promotion? Not Entirely.
Tuesday, February 19th, 2008“FDA Seeks to Broaden Range of Use for Drugs” read a headline in this past weekend’s New York Times. You’d be forgiven if you thought the article was about FDA trying to broaden the use of drugs—but in fact it was about something quite different: a new FDA draft guidance that would change the rules on the distribution of medical journal articles on unapproved uses of drugs.
Pharma has long distributed reprints on off-label uses of drugs, but the rules in recent years were onerous, and, of course, the HHS Office of the Inspector General (OIG) has been diligently pursuing off-label promotion as a particularly pernicious form of Medicare fraud. So the real questions for pharma, which weren’t addressed in any of the news articles I read are:
- Just how new is the new guidance, and
- How much protection from OIG will the guidance offer if it is ever finalized (more about that in a moment).
The answers: (more…)

