Sara J. Ray

Document Type



On November 18, 2011, the Food and Drug Administration (FDA) revoked accelerated approval of the breast cancer indication for Avastin, a cancer drug manufactured by Genentech. The FDA claims that Avastin, when used to treat metastatic breast cancer, does not provide a benefit that justifies the serious and potentially life-threatening risks associated with its use. The agency concluded that there was insufficient evidence that Avastin would help women with breast cancer live longer or improve their quality of life. This decision has sparked controversy and debate among women who want to keep Avastin available as an option to treat their breast cancer and view this decision as a death sentence. This Note discusses the importance of keeping Avastin available as a treatment option for women with metastatic breast cancer and the propriety of the FDA’s authority to remove approval of its use in the treatment of this life-threatening disease. In this Note, I will argue that there are wide-ranging problems resulting from the current system in which the FDA is able to regulate serious cancer drugs like Avastin. I further argue that these problems demonstrate that the FDA should no longer be the sole regulatory authority for cancer drugs like Avastin and propose an alternative system of regulation that is better aligned with the principle of patient autonomy.