Talking off the label – part three

Friday, November 6th, 2009

offlabel_3Allergan’s lawsuit filed against the FDA presents a relatively novel case in addressing the requirements of drug developers in relation to off-label use of drugs by physicians.

Allergan may be one of the many companies to follow suit in time. Allergan’s concern is the FDA’s stance – prohibiting communication to the medical community in regards to the common off-label uses of Allergan’s lead product – poses a violation of the first amendment rights under the US constitution. A pharmaceutical company should be able to exercise its rights under freedom of speech to provide truthful and relevant information to its users: physicians.

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Talking off the label – part two

Friday, October 30th, 2009

offlabel_2Following on from last week’s conversation, I left off with the issues surrounding the off-label prescriptive habits by physicians and the implicit role of the sponsors. The Academy of Managed Care Pharmacy (AMCP) supports off-label use of FDA-approved drugs when medically appropriate and necessary, but opposes government-mandated coverage of specific pharmaceuticals, whether for FDA-approved or off-label uses.

Mentioned last week was the original definition of off-label use as the use of a drug for clinical indications other than those stated in the labelling approved by the US Food and Drug Administration (FDA) and other regulators. An example would be the use of a drug for oncological treatment (e.g. pancreatic), where the drug would originally have been approved for treating other maladies of the same class (e.g. ovarian, bladder and genitourinary cancer).

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Talking off the label – part one

Sunday, October 25th, 2009

prescription_labelToday, and in the coming weeks I shall review the increasingly complex phenomenon in the pharmaceutical industry called off-label drug use.

In February 2008, the FDA issued a statement in which it said that it “recognises that the public health can be served when healthcare professionals receive truthful and non-misleading scientific and medical information on unapproved uses of approved or cleared medical products”. Senator Henry Waxman (Democrat), chairman of the House of Representatives Energy and Commerce Committee, implied that the Bush administration had given drug companies a long desired “parting gift”.

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