FDA Pursues Input as it Reviews Off-Label Communication Rules

The FDA wants advice from manufacturers and the public on off-label communications, one of the agency’s top priorities for 2016.

The FDA wants to know whether information from manufacturers is more informative than other off-label information, and what kind of limitations it should set. For example, it would like feedback on whether companies should be able to communicate directly with patients and consumers about unapproved uses and whether they should be required to provide disclosures in those cases.

The agency also needs advice on how it should monitor off-label communications and what the consequences should be for communications that are false, misleading or would raise public health issues. — April Hollis