Expansion of off-label promotion would jeopardize patient safety, says advocacy group

Lawmakers in the USA should oppose two proposals being considered that would significantly expand the marketing of medications and medical devices in a way that would be extremely harmful to patients, consumer advocacy group Public Citizen told Representatives yesterday.

In written comments submitted to the US House of Representatives Committee on Energy and Commerce’s Health Subcommittee, Dr Michael Carome, director of Public Citizen’s Health Research Group, urged the subcommittee to reject legislative proposals titled “Communications Regarding Intended Uses of Drugs and Devices; Scientific Exchange” and “Facilitating Exchange of Information Prior to Approval.”

The legislation would expand manufacturers’ marketing and promotion of medical products for “off-label” uses – uses of medications and devices that have not been approved by the US Food and Drug Administration as safe and effective for patients.