US consumer advocacy calls for stronger controls on off-label use of drugs and devices

The US Food and Drug Administration should strongly limit – not extend – off-label marketing practices for medicines and devices because it endangers patients, a leading consumer advocacy has said.

Public Citizen says experts have told the agency of these concerns, noting that research shows 80% of unapproved (“off-label”) uses lack sufficient evidence of effectiveness and are associated with a more than 50% increase in side effects compared to on-label uses.

“The FDA would be reckless to weaken rules and allow the pharmaceutical and medical device industry to promote products for which they are not proven to be safe and effective,” said Dr Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group. “Opening the door to the promotion of potentially dangerous products undermines the entire FDA approval process. The FDA needs to slam this door shut.”

Dr Wolfe, Robert Weissman (president of Public Citizen) and Dr Michael Carome (director of Public Citizen’s Health Research Group) were scheduled to testify on Wednesday at an FDA public hearing on the pharmaceutical and medical device industries’ push to market medications and medical devices for unapproved uses. Doctors are permitted to prescribe medicines and devices for unapproved uses, but manufacturers are prohibited from touting their products for those uses.

In recent years, the industry has incorrectly claimed a First Amendment right to distribute materials about unapproved uses of medical products and is pushing the FDA to relax restrictions. The FDA has proposed policy guidance that would permit additional off-label promotion by manufacturers.

In addition to presenting data highlighting the dangers of prescribing medical products for uses not proved to be safe and effective, Public Citizen explained: