The Online Asbestos, Asbestos Cancer, & Mesothelioma Authority
FDA
The Food and Drug Administration is the governmental agency whose stated mission it is to protect "the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation." The FDA is also responsible for "helping to speed innovations that make medicines and foods more effective, safer, and more affordable" (1).
The Center for Drug Evaluation and Research (CDER) is the branch of the FDA that is responsible for ensuring the safety and effectiveness of new medications and therapies. They work closely with pharmaceutical companies to ensure that new medications are rigorously researched and tested prior to approval (2).
In 2005, the FDA opened a new branch to focus exclusively on reviewing drugs and therapies used to diagnose, treat, and prevent cancer. The branch, called the Office of Oncology Drug Products, is within the FDA's Center for Drug Evaluation and Research, and is intended to streamline the treatment review process so that doctors and patients can have access to cancer treatments more quickly after they are developed (3, 4).
The FDA has only approved one drug, Alimta, specifically designed to combat mesothelioma. It received FDA approval in 2004, and is used in combination with a long-established chemotherapy drug, cisplatin. The clinical trials on which the approval of the drug were based showed that mesothelioma patients lived an average of one year after starting the drug in combination with cisplatin, while those who received cisplatin alone lived an average of nine months after starting treatment (5).
- "FDA's Mission Statement." From the FDA's website. Available: http://www.fda.gov/opacom/morechoices/mission.html (Accessed July 30, 2007).
- "The CEDR Handbook." From the FDA's website. Available: http://www.fda.gov/cder/handbook/index.htm (Accessed July 30, 2007).
- Twombly, Renee. "New Office and New Leader Aim To Streamline FDA Cancer Drug Review Process." (2005) Journal of the National Cancer Institute. Volume 97(10), 708-709. Available: http://jnci.oxfordjournals.org/cgi/content/full/97/10/708 (Accessed July 30, 2007).
- "FDA to Establish New Cancer Office and Program." From a July 16, 2004 FDA News Release. Available: http://www.fda.gov/bbs/topics/news/2004/NEW01091.html (Accessed July 30, 2007).
- "FDA Approves First Drug for Rare Type of Cancer." From the FDA's website. Available: From the FDA's website. Available: http://www.fda.gov/opacom/morechoices/mission.html (Accessed July 30, 2007).