Life sciences partner Kellie Combs (Washington, D.C.) was quoted in a Jan. 19 Pink Sheet article examining U.S. Food and Drug Administration (FDA) draft guidance for drug and device manufacturers on sharing health care economic information about approved or cleared drugs or devices with payors, and sharing other types of information with payors prior to product approval or clearance.
Ms. Combs, who recently testified at an FDA hearing on behalf of Ropes & Gray’s client, Medical Information Working Group (MIWG), notes that the FDA guidance provides some long-sought clarity. She is encouraged that in many cases the FDA adopted or agreed with MIWG proposals, including how to define the audience entitled to receive health care economic information and when health care economic information “relates to” the drug’s FDA-approved indication. (Subscription required)
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