BioCentury
ARTICLE | Politics & Policy

FDA sets standard for communications 'consistent with' labels

January 18, 2017 1:00 AM UTC

FDA issued draft guidance concerning medical product sponsors' communications, including promotional materials, that are "consistent with" products' labels, but not included in the labels. The guidance broadly recommended ways to convey "truthful and non-misleading" information that is consistent with a product's label, and compared specific examples of communications that "could be" consistent vs. those that would not be considered consistent.

For example, the guidance said information comparing two approved products for the same indication, providing context about adverse reactions, or discussing subgroups for which a product is approved could be consistent with labeling. The document says providing certain types of postmarketing data, including some patient reported outcomes, could also be consistent. Communications alone are not to be construed as evidence of a new intended use, the agency said...