Former FDA commissioner Robert Califf said healthcare marketers need to create a code of ethics to promote drugs for truthful and non-misleading uses outside their FDA-approved labels, commonly referred to as off-label promotion.
“Given the deregulated state [of off-label promotion], you need to come up with a code of ethics,” he told attendees at the Coalition for Healthcare Communication’s Rising Leaders Conference in Washington on Monday.
He warned that the actions of “unscrupulous” industry marketers could paint the industry in a negative light and potentially harm patients — especially absent a clear set of rules on how this type of promotion should be done. During Califf’s tenure as FDA commissioner, the FDA held a public hearing to discuss whether and how off-label promotion should take place, following the regulator’s legal settlements with Amarin, over off-label promotion of its fish oil pill Vascepa, and Pacira Pharmaceuticals, for its off-label promotion of post-surgical pain drug, Exparel. In both court cases, the regulatory victories went to the drugmakers.
“Your efforts should be truthful and non-misleading,” Califf added. “Truthful you get, non-misleading is really hard. It’s like a bad marriage, it’s not what you say. It’s what you didn’t say. The misleading part is where you need to focus.”
Califf also said he doesn’t necessarily agree that expanding the ability of drugmakers to engage in off-label promotion is a good thing. “I haven’t seen a whole lot of good come from real off-label promotion,” he said. “Companies are just going to advertise their experiences, and you can look at 100 experiences and pick 5 that look good.”
Califf did point out, however, that the FDA, in its role as a regulator, needs to be involved in the evolution of off-label promotion rulemaking. “We need a rational system to deal with accumulating information about off-label uses,” he said. “We need to develop that information into FDA so it gets on the label.”
Following the hearing in November, the FDA released draft guidance on how the industry could share information about therapies consistent with their labels but in a broader context than their approved labeling.