Congress Must Handle Off-Label Talk Restrictions Carefully, Experts Tell Lawmakers
Executive Summary
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.
You may also be interested in...
US FDA User-Fee Bill Swiftly Passes US House, Now Moves To Senate
The FDA Reauthorization Act, which would reauthorize the MDUFA IV user-fee agreement and enact additional device regulatory reforms, passed the US House July 12 on a unanimous vote. Lawmakers applauded the bill's inclusion of device facility inspection reforms and an over-the-counter hearing aid provisions. The legislation now moves to the Senate, where a crowded legislative schedule could mean delayed consideration.
House Committee Advances User Fees With Full Slate Of Device Amendments
House Energy and Commerce Committee members added a slate of industry-favored device amendments into the FDA Reauthorization Act before sending the bill to the chamber floor, including reforms targeting device accessories, medical imaging and post-market surveillance.
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US FDA has collected more than 100 comments on a pair of draft guidance documents about manufacturer speech relating to unapproved devices or information not listed in device labeling.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.