Big Pharma asks FDA for clear off-label rules

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.

"That lack of clarity places manufacturers at risk of criminal and civil sanctions if they cannot correctly guess where the government would draw a line [on information about off-label uses]," wrote lawyers for those companies (as quoted by Medical Marketing & Media). "Industry should not have to refer to the terms of DoJ settlements or informal statements of FDA officials to learn what is expected of them prospectively."

The companies say the FDA has to step in to protect the public health; otherwise, pharma firms will continue to either over- or under-communicate about unapproved uses, depending upon how they interpret the DoJ and FDA tea leaves.

- read the MM&M story