FDA
The Food and Drug Administration (FDA) 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."
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.
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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.
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.