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Congress Must Handle Off-Label Talk Restrictions Carefully, Experts Tell Lawmakers

 
• By Sue Darcey and Cathy Kelly

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.

Capitol House

The House Energy & Commerce Health Subcommittee's July 12 hearing on the dissemination of off-label information on devices and prescription drugs focused on arguments for and against the need for legislation to relax US FDA restrictions. Attorneys and physicians knowledgeable with the topic cautioned that changes made via legislation would have to be handled carefully to allow FDA some controls, but not to prohibit communications so much that it triggers free speech protections.

"If government wants to restrict off-label speech, it really has an uphill battle," Sidley Austin attorney Coleen Klasmeier commented.

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