Unapproved Indications Guidance Proves Controversial
US FDA has collected more than 100 comments on a pair of draft guidance documents about manufacturer speech relating to unapproved devices or information not listed in device labeling. A document allowing manufacturers to disseminate some information not in the labeling drew fire from both sides, with patient groups worrying the change could pose a risk to the public, while trade groups saying the communication protections were still too narrow.
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The US House Energy and Commerce Health Subcommittee advanced a Republican-sponsored bill that would permit communications between manufacturers and private and public insurers about the benefits of unapproved devices and drugs. Democrats on the panel expressed strong reservations that FDA may feel unduly pressured by insurers to rush through product approvals.
The ongoing push for less US FDA regulation of speech that is truthful and not misleading should continue through the next several years, experts say.
Two House Energy & Commerce Committee members have introduced legislation to provide clarity and more latitude in off-label communications by manufacturers about devices and drugs, and a panel of legal experts and physicians provided feedback on the topic to the committee's Health subpanel July 12.