off-label use

Blog entry

Alzheimer's Research does not Create "New Drug"

On February 8, 2012, Science magazine published research showing that bexarotene (Targretin®), a drug approved for use in the US by the FDA for the very specific purpose of treating cutaneous T-cell lymphoma [CTCL] that can not be treated successfully with at least one other medication, that it can reduce brain amyloidal beta protein fragments in mice breed for Alzheimer's disease, increasing social skills and the sense of smell. http://www.sciencedaily.com/releases/2012/02/120209144005.htmMore »

Alzheimer's disease, experimentation, FDA regulation, INDA, IRB, off-label use

News Story

Atypical Antipsychotics Appear to Be Effective for Only Few Off-Label Uses, Study Suggests

09/28/2011

A review of previous studies suggests that even though atypical antipsychotic medications are commonly used for off-label conditions such as behavioral symptoms of dementia, anxiety, and obsessive-compulsive disorder, these medications are effective for only a few off-label conditions, and that the benefits and harms of these medications for these uses vary, according to an article in the Sept. 28 issue of JAMA.More »

antipsychotics, off-label use

Big Pharma Asks FDA for Clear Off-label Rules

07/08/2011

If the drug industry has been unsuccessful at gaining FDA guidance on social-media marketing, then maybe it can get the agency to speak about another promotional thicket. This time, pharma companies are seeking clarity on off-label drug use. Namely, what they can and can't say about maladies their products aren't FDA-approved to treat.

Seven drugmakers have written the agency to petition for details, saying that current FDA rules are murky and precarious. What if doctors ask about an off-label use, completely unprompted? What about payors? Clinical guidelines produced by third parties? And so on. It's not a trivial issue, as those 7 companies know; among Allergan, Eli Lilly, Johnson & Johnson, Novartis, Novo Nordisk, Pfizer and Sanofi are some record-setting, multibillion-dollar marketing settlements with the Department of Justice.More »

FDA, off-label use
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