Off-label use of drugs

Third, the law changes the treatment of off-label use of drugs—that is, drugs used for purposes other than those for which it received approval. According to the FDA,... 

The most extensive experience with tissue adhesive drug delivery exists in the fibrin sealant literature. This is clearly an off-label use of this agent as it is only currently approved for hemostasis in cardiac and splenic trauma surgery and for colon sealing at the time of colostomy closure. 

Authorises manufacturers of new drugs to disseminate information on unapproved (off-label) uses of approved products under very limited conditions. 

Off-label information Scientists and health care professionals may engage in scientific exchange of information not contained in approved labelling, but care must be taken to ensure that no statements are made that might be construed as promoting an off-label use of any approved drug product. These discussions should not occur at the exhibition booth. 

Side-effect profiles of many antiobesity drugs have led to high attrition rates, lessening the overall appeal of pharmacotherapy as a treatment option. In general, anti-obesity drugs should have fairly mild and non-life-threatening side effects, because of the potential off-label use of such compounds for cosmetic purposes in relatively healthy individuals. 

Should the company obtain an approved indication or should it allow off-label use of the drug to provide whatever commercial value it obtains This is often viewed as an exercise in cost accounting, whereby the company totes up all the costs and resources used to obtain the indication and compares the total with the potential sales and profits that would accrue with each approach. It is important to consider the opportunity cost of working toward an approved indication (i.e. if one spends x dollars and uses y staff months to obtain the indication, then those staff cannot be working on other projects and the money cannot be applied elsewhere). 

Many State Medicaid programs restrict payment for off-label uses of prescription drugs however, the restrictions are applied only to a few very costly drugs. Therefore, the overall impact of such Medicaid restrictions is minor. 

It should be noted that the experimental (or off-label ) use of approved (i.e. lawfully marketed ) drugs is exempt from the need for an Emergency IND, under 21CFR paras 312.2(b)(i)-(v), provided that the intended use ... 

Owners must be cautioned to avoid off-label uses of therapeutic drugs unless there is a valid veterinarian-client-patient relationship. 

Very few injectable dosage forms have been specifically developed and approved by FDA for intraocular use. However, the ophthalmologist uses available parenteral dosage forms to deliver antiinfectives, corti-costerioids, and anesthetic products to achieve higher therapeutic concentrations intraocularly than can ordinarily be achieved by topical or systemic administration. These unapproved or off-label uses have developed over time as part of the physician s practice of medicine. However, these drugs are usually administered by subconjunctival or retrobulbar injection and rarely are they injected directly in the eye [301]. 

---