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Ex-FDA Commish Califf Says #Pharma Needs a Code of Ethics to Prevent "Misleading" Off-Label Marketing

Ex-FDA Commish Califf Says #Pharma Needs a Code of Ethics to Prevent "Misleading" Off-Label Marketing | Pharma Industry Regulation |

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 (read "Strike 2! FDA Avoids Another Off-Label Court Fight by Capitulating to Pacira's Demands";, 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.”


Further Reading:

  • “To Avoid "Chaos," Wonks Propose Non-FDA Panel “Rank, Score, or Grade” Off-Label Communications”;
  • “Duke Chimes in on Off-Label Drug Promotion. Will Califf Concur?”;
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