Off-Label Ltd

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First-ever database containing the latest reports of the off-label use of drugs

In order for a pharmaceutical/biotechnology company to promote and sell a medicine, the company must first obtain a license (or ‘label’) that authorises uses for which the drug has been shown to be effective without causing unacceptable side effects. It is important to emphasize that this license/label is intended to regulate the activity of the company which must market the drug strictly for those conditions that are clearly described within the license/label. This licensing process does not regulate a doctor's prescribing practice. In the UK for example, the Medicines Act 1968 specifically safeguards a doctor's clinical freedom.

When a drug is used to treat a condition or manage a symptom that is not included within the Marketing Authorization/label, or when the administration or population to which it is administered differs from that defined, then such use is known as 'off-label'.

While it can take several decades (usually about 2) for a new drug to progress from discovery into clinical practice, in reality when a drug becomes available to prescribers this represents the start of a never-ending learning process. Many drugs have more than one mechanism of action and the specific targets of a drug's pharmacological activity will often be expressed in many different disease states. Such profound overlap means that virtually all drugs have important uses that are not those for which the drug was originally approved, and which only become apparent with increasing clinical use.

For many specialties that include Palliative Care, Oncology, Psychiatry, Neurology, Pain, and Gastroenterology, off-label use is an essential and necessary component of patient care. Cumulatively, the off-label use of drugs is an invaluable resource that in addition to providing prescribers with an evolving supply of new and exciting therapies, also gives researchers and manufacturers new insights for the development of future drugs.

Off-Label Ltd offers the healthcare profession, industry, and academia an efficient, easy-to-use and rapid tool to access this resource. OFF-LABEL Database is the first-ever on-line facility dedicated to searching information that details the off-label use of over 500 drugs. The database is updated daily and grows by approximately 400 new entries each month. In addition to a UK version, a US version formatted according to the contents of FDA labels was launched in October 2004.

A large number of medicines information resources provide catalogued and indexed facts on the licensed use of drugs. This is not the case for information relating to off-label use. Since drug companies must not promote the off-label use of their drugs, concerted efforts to systematically organize this sea of data have been lacking, giving rise to a serious information gap. Today these data are systematically catalogued and made available to prescribers and other users through the off-label information portal.

Off-Label.com enables prescribers and others to search for potential therapies when approved licensed uses of a drug have been ineffective or where an off-label use may offer a better outcome for the patient.

Additionally Off-Label.com is popular with Pharma and Biotech who find it a useful resource to quickly identify the latest off-label reports on uses of their own drugs, those of their competitors, and importantly as a monitor to search for uses with potential for commercialization.

For all of you who play a role in the fight against disease, OFF-LABEL Database is a new facility created with the sole purpose of enhancing your daily search for information.