FDA’s Off-Label Communications Guidance Needs More Clarity, Industry Says

Drugmakers said the FDA’s draft guidance on off-label communications is a good start, but needs clearer language.

For example, the agency’s draft says that company suggestions to deviate from approved doses or regimens are not consistent with FDA-required labeling, but fails to account for need to alter or interrupt doses, according to Pfizer.

In comments on the draft, Pfizer called on FDA to clarify that manufacturer communications about how to manage changes or interruptions would be consistent with agency labeling.

The draft guidance is also overly vague in its distinction between scientific and promotional communication, according to PhRMA.