Examples of public unsolicited requests include scenarios in which an individual asks a question regarding an off-label use during a live presentation or posts a question about an offlabel use
on either a firm-controlled website or a third-party discussion forum that is visible to a broader audience.
Covert promotion of pharmaceuticals is an important public health issue because it can contribute to unnecessary overuse of certain drugs or lead to their offlabel use
without sufficient evidence of efficacy, the Canadian journal said in an accompanying editorial.
Integrating evidence-based criteria to support utilization management and optimize therapeutic regimens can minimize experimental or offlabel use
of high-cost medications and decrease variation in dosing or frequency, as well as reduce potentially inappropriate sub- or supra-therapeutic dosing.
While the FDA does not regulate offlabel use
--leaving it up to providers' clinical judgment to prescribe medicines appropriately--it does prohibit pharmaceutical companies from marketing drugs for unapproved purposes such as offlabel use
For Gorillacillin, an offlabel use
would be in a child with pneumonia, or in an adult with a foot infection.
Although treating an overactive bladder or sphincter with Botox is an offlabel use
of the product, it's still possible to get paid for it.
YES This may be appropriate for some women who have given adequate informed consent regarding the offlabel use
and experimental nature of the prescription.
Governments in Europe and Japan have acknowledged a valuable role for appropriate offlabel use
of cancer therapies, but tough reimbursement restrictions severely limit physicians' prescribing freedoms.
In Amarin, a pharmaceutical company wanted to promote offlabel uses
for one of its drugs, but it did not want to risk misbranding charges.
Department of Justice negotiated a settlement agreement in which Allergan pled guilty to criminal misbranding charges related to the firm's promotion of Botox for offlabel uses