Lawmakers Should Reject Proposals for Expansion of Off-Label Promotion, Public Citizen Tells House Lawmakers

July 12, 2017

Lawmakers Should Reject Proposals for Expansion of Off-Label Promotion, Public Citizen Tells House Lawmakers

Proposals Would Jeopardize Patient Safety

Lawmakers should oppose two proposals being considered today that would significantly expand the marketing of medications and medical devices in a way that would be extremely harmful to patients, Public Citizen told representatives today.

In written comments submitted to the U.S. 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 U.S. Food and Drug Administration as safe and effective for patients.

“These bills would threaten patient health and safety by undermining the current regulatory regimes for ensuring that drugs and medical devices are safe and effective for each intended use. Similar legislation was considered by Congress during the drafting of the 21st Century Cures Act but was wisely rejected because of its controversial nature,” Carome wrote.

Although prescribing for unapproved uses is common, scientific evidence supporting most such uses often is lacking, Carome noted. For example, a recent study conducted in Canada found that the vast majority of off-label uses—81 percent—lacked strong scientific evidence of effectiveness. Patients who received a prescription for an off-label use lacking strong evidence of effectiveness were 54 percent more likely to experience an adverse reaction that resulted in stopping use of the medication than were those who were prescribed a medication for an approved use.

Even relying on peer-reviewed scientific journal articles can be dangerous, he said. The peer-review process suffers from shortcomings that can permit fraudulent or otherwise misleading articles to find their way into publication. Objective evaluation by the FDA is crucial to ensuring that medicines and medical devices are safe and effective.

Read the comments here.