Alliance submits comments to FDA on off-label use of oncology drugs

Posted:05/2/14

This week, the Ovarian Cancer National Alliance submitted comments to the Food and Drug Administration (FDA) about a proposed Guidance for Industry that could have the effect of limiting patient access to “off label” oncology drugs. In cancer, many people are prescribed treatments approved for other uses, but not currently approved for a particular disease. This practice is legal and in many cases consistent with well-established medical treatment guidelines. For example, Avastin is sometimes prescribed to women for maintenance following chemotherapy, despite not having a current indication for ovarian cancer from the FDA.

The Alliance feels that patients should continue to have access to medicines that their physicians determine will benefit their care. In the comments the Alliance submitted to FDA, we emphasized this position and urged the FDA to reconsider any statement which may have a chilling effect on a physician’s decision to prescribe a drug “off label.”

To see a copy of the letter the Alliance sent FDA, please click here.