Instead, it resorted to a legal technicality: rather than prosecuting off-label
advertising outright, it would use off-label
speech as evidence of misbranding, a maneuver that supposedly would not violate the First Amendment.
If a manufacturer attempts to recommend usage or disseminate information that has not been approved by the FDA, such "off-label
" promotion is considered misbranding, and has regularly met with heavy fines and other penalties.
prescribing has gained popularity as the process of obtaining modifications to a product license of an existing drug is lengthy and costly.
Background on Off-label
Drugs and Medicare Part D A.
Although clinicians may cite guidelines that support off-label
use of gabapentinoids for pain, the investigators warned that many of these recommendations stand on shaky ground.
use under CLIA '88 requires providers to restrict the use of these devices to CLIA-waived operators.
" drugs are drugs prescribed for a purpose other than those for which they are approved by the Food and Drug Administration (FDA).
"Developmentally, [children] may be unable to verbally express the side effects they are feeling and may therefore be subject to a drug to treat a drug side effect, especially if their reaction to it is behavioral." There is also potential for unanticipated drug interactions between off-label
medications prescribed for sleep and drugs prescribed to treat ADHD.
The NWHN supports clinicians' right to prescribe products off-label
for a different population, dosage, or use outside of FDA guidelines, giving them freedom to fine-tune treatments to patients' needs or adjust to research advances that have overtaken regulation.
It's also been the law for decades that FDA doesn't regulate the practice of medicine, and that once a drug's approved for one use and lawfully on the market, doctors can decide to prescribe it "off-label
" for anything they want.