The FDA finalized guidance clarifying rules for communicating health care economic information and pre-approval information with payors and for promoting information that is consistent with, but not included in, a product’s labeling. Articles in June 13 -14 Inside Health Policy and Medical Marketing & Media include remarks from life sciences partner Kellie Combs (Washington, D.C.), who represents the Medical Information Working Group, a coalition of drug and medical-device makers that has long been advocating for increased clarity and flexibility in the regulation of manufacturer communications.
She explains that FDA acknowledges in the guidance documents the value of information that does not appear in product labeling. She also explains that the payor guidance represents a significant shift in policy, as FDA now permits manufacturers to share information about unapproved products and uses with payors.
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