Off-label options

Bringing FDA's oversight of communications about off-label uses of medical products into compliance with the courts' interpretation of constitutional protection of speech will be one of FDA Commissioner Robert Califf's more pressing and difficult challenges. The Duke-Margolis Center for Health Policy, a new think tank directed by former CMS Administrator and FDA Commissioner Mark McClellan, released a white paper last week that could help.

Policy Options for Off-Label Communication: Supporting Better Information, Better Evidence, and Better Care notes that the courts have rejected several attempts to enforce restrictions on off-label communication. The result has been "an unsatisfactory and unsustainable patchwork of regulations, guidance documents, and agency practices related to off-label communication, product labeling, and scientific exchange of information," according to the white paper...