Off Label Essay

Off- Label discussion before and During Clinical Trials

INTRODUCTION:

Off- Label drug use is usage of drugs, marketed medications for an indication (disease or symptom) that has never been approved by Food and Drug Administration (FDA), it also applies to population and dosage form that does not have approval from FDA. The product is already approved by FDA but for different indication, which is indicated on the label. Off- Label use is not inappropriate or dangerous, the product’s safety is already determined and it has all rights to be on the market, but the only problem is the safety studies or efficacy studies on product is not completed to determine the particular use. The main reasons behind off label uses is that medical community

Though physicians with time find the new uses of these products that are not labeled. These uses are safe but not scientifically proved and these relieves the financial pressures for the organizations which is useful in increasing the sales of the product in the next quarter, this might lead to adding up additional pressure on corporate to increase the sales using this additional benefit. This might create new tension in the organization, as the organization has to keep up with the off-label sales going and increasing the sales without involving in the off-label promotion. With these three assumptions financial pressures, resource constraints and compliance expectations the main focus will be shifted to Research and Development team, clinical and marketing organizations. The development of new indications for existing products should be figured out by the clinical organization and set the budget limits and achieves the company goals within the available

The data from clinical trial will be submitted to FDA and further it gets approved what if its not get approved or what if the information is leaked out through the investigator, the organization should address such kind of off-label issues.

Promotion:

Promoting the product is very important from the organization point of view but what matters is that the product should be promoted only for the approved or intended use other that that it is considered as illegal promotion as per the Federal Food Drug and Cosmetic Act (FDCA). For example the drug with approved use for arthritis should be prescribed only by orthopedic but not by the cardiovascular specialist.

Dissemination:

The First amendment allows exchange of medical and scientific information as “free speech” under certain conditions. Washington Legal Foundation (WLF) and section 401 of the Food and Drug Administration Modernization Act (FDAMA) allow the dissemination of the information.