When a provider chooses to use a glucose meter off label
, the hospital and laboratories must possess a CLIA Certificate of Compliance (CoC) or Certificate of Accreditation (CoA), establish the performance specifications (i.e.
The data yielded 14,567 prescriptions for 2,518 children for a 30-day supply of medication known to potentiate sleep but off label
indications for antidepressants included, GAD, social anxiety disorder and panic disorder (Table 3).
545, 560 (2014) ("FDA defers to physician discretion to prescribe off label
, because it remains ignorant about safety and efficacy claims until they are proven.").
Physicians are free to prescribe off label
, and physicians, pharmacists, and anyone else can tout the off-label uses of a drug.
The discretion of doctors and other healthcare-team members who are licensed for prescribing drugs (pharmacists and specially trained and qualified nurses) to prescribe products off label
1998), the court held that an FDA guidance restricting certain forms of manufacturer promotion of off label
uses imposed unconstitutional restrictions on commercial speech under the First Amendment.
Because Caronia protected only truthful, non-misleading off label
promotion, one would expect that in future off label
cases the government would allege that the promotion included false or misleading messages (e.g., overstating the drug's efficacy or minimizing safety issues).
Is the oncologist required to use only the FDA-approved FISH test off label
, or could the oncologist use another non-FDA approved ALK test and not violate FDA regulations?
It is unsettled whether a physician is obligated to inform patients that a drug's proposed use is considered off label
. As a practical matter, it may be difficult to explain why its use is as yet unapproved by the FDA.
The courts, however, take a different approach to off label