San Francisco Chronicle Examines Debate Over Disclosure of Off-Label Prescriptions
The San Francisco Chronicle on Sunday examined the "growing chorus" of supporters for a law to require physicians to disclose to patients when they prescribe prescription drugs for off-label uses -- those not approved by FDA. Under current law, after FDA approves a new prescription drug as a treatment for a specific condition, physicians can prescribe the medication for off-label uses.
According to a 1992 American Medical Association study, off-label prescriptions account for 40% to 60% of total U.S. prescriptions. The effect that off-label prescriptions have on patients "can be hard to gauge, because the treatments are tried outside the controlled conditions of clinical trials," but reports have linked some off-label prescriptions to deaths and other severe side effects, the Chronicle reports.
Arthur Levin, executive director for the New York-based Center for Medical Consumers, said, "If it's not an approved use, they're taking it experimentally. They should decide that, and decide whether they want to participate." Supporters of disclosure of off-label prescriptions also maintain that the practice could prompt patients to ask more questions, seek other sources of information, monitor side effects or ask for a treatment approved by FDA.
However, physicians maintain that disclosure of off-label prescriptions would "only scare patients, possibly spurring them to refuse a medicine they sorely need," the Chronicle reports. In addition, according to AMA, off-label prescriptions in some cases represent the most effective treatment available (Tansey, San Francisco Chronicle, 5/1).