Risky Business
Vol. 2, No.11: December 2003
OpEd by John Mack
Paraphrasing a comment I heard at a recent industry conference, “a product manager with an FDA warning letter framed and hanging on the office wall has bragging rights.”
Perhaps this allegory of bravado is just a PM “urban legend.” Nevertheless, designing and implementing pharmaceutical marketing campaigns is a risky business these days, as pharma companies contend with intense public scrutiny.
Product managers may take more risks than necessary and there may be few regulations that define a bright line between allowed and not allowed activities.
Off-label communications is a case in point. There are no regulations or firm guidance from the FDA on dissemination of off-label information. Often, the limits are being set by court decisions resolving federal false claims cases. Clearly, this is not where pharmaceutical companies want to be.
All the public scrutiny has led to new guidance from the OIG, self-regulatory guidelines from the pharmaceutical industry itself, and pressure from non-governmental organizations like the ACCME. The result is more work for pharmaceutical compliance officers who are playing a larger role in pharmaceutical marketing.
Marketers need to understand the rules, but also work more closely with compliance officials – suggestions for how to do this can be found in this month’s article “Integrating Compliance into Commercial Practices.”
Experts warn regulators are putting off-label promotion at the top of their “most-wanted lists.” So, before you begin an off-label information dissemination program, be sure to read the “Seven Steps to Safety” outlined in the article “Guidelines for Off-label Communication.”
