off label


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off label

adj, adv (off-label when prenominal)
(Medicine) (of a prescription drug) relating to use, or being used, in ways for which it has not been approved
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This proposal suggests that courts hold manufacturers generally liable under the civil FCA for excess profits from improper Medicare Part D off label reimbursement.
For example, when physicians routinely prescribed hormone replacement therapy off label to postmenopausal women in the 1980s, the women were exposed to an increased risk of breast cancer, heart attack, and stroke.
Antipsychotic drugs, notably Seroquel, Zyprexa, and Abilify, are prescribed off label for conditions not approved for by FDA, including behavioral problems in toddlers, anxiety, and attention-deficit disorder.
Are there Legal Regulations relating to Off Label Prescription and Promotion of Drugs?
Enforcement Mechanisms by FDA Designation Physician/ Required Promotion FDA Designation Pharmacist Diagnostic Bar Liability Codes Red-Box Uses R [check] [check] [check] Black-Box Uses E [check] [check] Gray-Box Uses M [check] [check] Unboxed Warning S [check] No Warning & [check] Conditional Off Label E On-Label T A S U Dental of Heightened FDA Designation Medicare/ Malpractice Medicaid; Liability Reimbursement Red-Box Uses R Black-Box Uses E Gray-Box Uses M Unboxed Warning S No Warning & Conditional Off Label E On-Label T A S U Check marks indicate the presence of an enforcement mechanism.
Summary: In December 2012, the 2nd Circuit issued a groundbreaking 2-1 decision, holding that the First Amendment protects the truthful, non-misleading off label promotion of pharmaceutical .
It is unsettled whether a physician is obligated to inform patients that a drug's proposed use is considered off label.
The courts, however, take a different approach to off label prescribing.
These uses were off label during the relevant time frame, and thus the labeling for Botox did not bear directions for these intended uses, resulting in the product being misbranded.
10) Although drug companies are not allowed to promote drugs for off-label uses, the FDA "does not regulate the practice of medicine and recognizes that physicians may determine that prescribing a drug off label constitutes good care.
Motivation for the off label use of bevacizumab (Avastin) and triamcinolene acetate (Kenalog) as intravitreal injections.