2012  •  

Off-label Use of Medicinal Products in Healthcare Industry: Do the benefits outweigh the high risks associated with public health?

Lead Presenter: Siddhartha Chowdhury

Off-label use means using a regulated medicinal product in a manner that is not consistent or inconsistent with the products label claim(s). Off-label use may be either problematic or on the other hand may even be the standard of care. The problem is that Off-label use of drugs and devices has become rampant in medicine today. Why? Because the U.S. FDA cannot regulate the practice of medicine. As a result of this, manufacturers have no control on how the product will be used. In 73% of the Off-label use, doctors had little or no scientific evidence to back up their choices. Drug marketing plays a major role in this. The biggest concern now is about liability. If something bad happens to a patient, can the manufacture be held liable? In other words, regardless of what the manufacturer puts on the label, if the plaintiff can show that the manufacturer should have known of the products Off-label use, they can be held liable. So, what is the solution to the Off-label use problem? The FDA is handicapped in this case as it does not regulate the practice of medicine. The solution lies with the Center for Medicare and Medicaid Services (CMS), i.e., reimbursement. If the physicians cannot reimburse for Off-label use of a product, how many would continue to use it Off-label? This would also force manufacturers to conduct additional trials to add indication to the label. This way we have limited without eliminating the Off-label use problem.