The Houston drug injury lawyers at Denena & Points realize that you might not be aware that up to about one third of the medications prescribed to patients in the United States are thought to be “off-label.” This means that patients’ physicians have prescribed the medications for uses or conditions for which the FDA has not approved the drug.
The reason for this is the broad professional discretion granted to physicians to customize their patients’ care based upon the presumed superior knowledge of the attending physician regarding the individual patient’s needs. So off-label prescription drugs is not as dangerous or frightening as it might at first appear.
Our Houston drug injury lawyers point out that off-label prescribing might address such needs as individual doses, the need to avoid allergens in certain medications, or the need for special compounding of an otherwise unavailable medication. The FDA does not regulate a physician’s prescription of off-label medications. The state medical licensing and regulatory authority oversees such activities.
The federal Food, Drug, and Cosmetic (FD&C) Act says that a manufacturer cannot label, promote, or advertise a drug for uses other than those for which the medication’s safety and effectiveness have been established and for which the FDA has granted its approval. These approved uses will be listed on the drug’s label.
The FD&C Act does not similarly limit the uses for which a physician may prescribe an approved drug. Once the FDA has approved a drug for the U.S. market, individual physicians may prescribe the drug for uses, conditions, treatments, and patients for which the drug has not been officially approved and labeled.
The lack pf restriction on physician prescription of the drugs exists because the broad professional discretion granted to physicians recognizes that in some circumstances, it might be effective and rational to use a drug for a use for which it has not yet been specifically tested and approved. Our Houston drug injury lawyers emphasize that such novel uses of the drug might be extensively observed by physicians and reported in the medical literature even if they never undergo clinical trial and the FDA approval process.
In some cases, however, compounding pharmacies may seek to create “extra strength” drugs and market them widely for profit. Or physicians may over-prescribe medications like painkillers that might be subject to abuse by patients. In these instances, off-label or unapproved prescription practices could be harmful.
Learn more about what compounding pharmacies do and how their products reach the individual patient. Click here to read our Houston drug injury lawyers’ in-depth look at compounding pharmacy practice.