Off-label drug use refers to prescribing a drug for a different reason than the one for which it has received FDA approval.
We all know that research divisions for pharmaceutical companies are constantly looking for new drugs, but what you may not realize is that they are also on the lookout for new uses for existing drugs. As new applications are found for existing formulas, potential use of the drugs goes up, and so do profits.
Doctors are permitted to prescribe a drug off-label, if they believe, in their medical judgment, that it will be helpful to their patient. However, drug companies and drug company representatives are not permitted to market the drug for its off-label use.
To market a drug before it has been proven safe and effective is not only dangerous, it is illegal. And when marketing comes with incentives to try certain drugs – whether for on or off-label use – it is a violation of the kickback rules.
Protect patients and help the FDA monitor appropriate uses for pharmaceuticals. Contact Bothwell Law Group if you know about kickbacks or off label marketing for drugs and we will help you figure out what to do.