We saw this morning the attached description of consumer awareness, and approval, of off-label use of prescription drugs. (This squib came from a service available at firstname.lastname@example.org, but we weren’t sure that a link would take you directly to this item, so we’re reproducing the item here, with attribution.) For lawyers trying cases that involve off-label use of a drug or device, it may be helpful to know jurors’ uneducated reaction to off-label use. Here’s the squib:
Study: Patients Unsure About Viability Of Off-Label Prescriptions
ROCHESTER, NY (Managed Care Wire): U.S. adults are either divided or ambivalent when it comes to the issue of off-label prescription drug use, according to the latest Wall Street Journal Online/Harris Interactive Health-Care Poll. While it is legal for doctors to prescribe prescription drugs for diseases other than those for which they have been approved by the U.S. Food and Drug Administration (FDA), there are strict rules governing the marketing of a drug for treatment of a disease for which it hasn’t been approved. About one-third (27 percent) of adults say that prescribing drugs off-label should be allowed, while one-third say in most cases, the risks of doing so outweigh the benefits.
Interestingly, half (50 percent) of all adults incorrectly believe that once a drug is approved, a doctor can prescribe it only for the diseases for which it has been approved by the FDA, and another quarter (25 percent) are unsure. Nearly half (48 percent) think that doctors should not be allowed to prescribe drugs for off-label uses and even more (69 percent) think drug companies should not be allowed to encourage off-label use. However, a plurality (55 percent) agrees that if doctors aren’t allowed to prescribe freely, it will be much more difficult to find new and innovative ways to treat diseases.
Approximately one in three (31 percent) adults believes that in most cases, the benefits of off-label prescription drug use outweigh the risks, but an equal proportion (34 percent) believes the opposite is true. The greatest level of agreement amongst adults in this poll is on the potential prohibition of off-label prescription drug use, except as part of a clinical trial, with nearly two-thirds (62 percent) agreeing with such restrictions.
Payers looking for ways to contain the rising costs of healthcare can take away one clear message from the study’s results. “Precedent has been set for prohibiting payment for certain types of surgical procedures except to patients who are enrolled in a clinical trial,” explains Katherine Binns, Division President of Healthcare Research for Harris Interactive. “These findings suggest that U.S. adults do not want to hamper innovation, but would also be supportive of increased oversight and limitations being applied to the off-label use of prescription drugs.”