On June 12, the U.S. Food and Drug Administration (FDA)
published two new guidance documents that address how companies can
share off-label information with insurers and healthcare
professionals about drugs and medical devices, as well as
information for uses that haven't yet been approved.
One guidance, "Drug and Device Manufacturer Communications With
Payors, Formulary Committees, and Similar Entities –
Questions and Answers," addresses how drug and medical
device companies can share economic and other information about
drugs and medical devices with insurance companies and other
payors. The other, "Medical Product Communications That Are Consistent
With the FDA-Required Labeling – Questions and
Answers," addresses how companies can communicate to
healthcare professionals and others information that is not
contained in a product's labeling, but is still consistent with
the labeling. This information may include data from post-market
studies and surveillance of a product's approved uses;
additional information from the pre-market studies that were used
to support approval of the product, including what uses haven't
yet been approved by the FDA; and scientific studies, including
studies comparing the safety and efficacy of one drug to
another.
The past three month of FDA guidance documents can be
found on the FDA's website.
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