FORT LAUDERDALE, Fla. – There are steps that physicians can take to limit their liability when prescribing approved drugs for off-label use, according to an attorney speaking here.
First, inform the patient that the drug is being prescribed for an off-label use, attorney William P. Ramey III said here at the Association for Research in Vision and Ophthalmology annual meeting.
Second, the drug should not be prescribed for research purposes; rather, the prescription should be made principally to diagnose, treat and directly benefit the patient.
The physician is considered the expert in these matters, Mr. Ramey said, and the prescription should be made using the physician’s own expert medical opinions. Furthermore, the use of the off-label drug should be supported by peer-reviewed articles reflecting sound scientific evidence, documented medical practice, and, if possible, the opinions of the physician’s local colleagues.
For manufacturers of approved drugs and devices, Mr. Ramey makes another list of recommendations: “Do not promote off-label uses; if the manufacturer becomes aware of a risk for a known off-label use, the manufacturer may have a duty to add warning; do not support organizations that promote off-label use of the drug or device; and do not allow sales force to promote off-label uses to sell more devices or drugs.”
- Disclosure: Mr. Ramey has represented Merck and Alcon in the past.