Lexology July 24, 2025
The Department of Health and Human Services Office of Inspector General (HHS-OIG) published a favorable advisory opinion earlier this month, Advisory Opinion 25-07, approving an arrangement through which a biopharmaceutical company (the Requestor) provides free testing to patients who are diagnosed with a particular condition to determine whether the patient has a subtype of condition for which the manufacturer has an approved medication (the Arrangement). This opinion follows two favorable advisory opinions on manufacturer-sponsored testing (see prior Sidley Updates here and here).1 The opinions to date provide a helpful set of potential safeguards that labs and their partners may wish to consider when contemplating sponsored arrangements with drug or device manufacturers.
The Proposed Arrangement
The Requestor manufactures an FDA-approved medication...
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