If the drug industry has been unsuccessful at gaining FDA guidance on social-media marketing, then maybe it can get the agency to speak about another promotional thicket. This time, pharma companies are seeking clarity on off-label drug use. Namely, what they can and can't say about maladies their products aren't FDA-approved to treat.
Seven drugmakers have written the agency to petition for details, saying that current FDA rules are murky and precarious. What if doctors ask about an off-label use, completely unprompted? What about payors? Clinical guidelines produced by third parties? And so on. It's not a trivial issue, as those 7 companies know; among Allergan, Eli Lilly, Johnson & Johnson, Novartis, Novo Nordisk, Pfizer and Sanofi are some record-setting, multibillion-dollar marketing settlements with the Department of Justice.More »