The Food and Drug Administration
• modify the Food, Drug and Cosmetics Act of 1938 to allow pharmaceutical companies to opt out of Food and Drug Administration testing requirements and to use alternative organizations to certify product safety and efficacy and • allow individuals the freedom to use any non-FDA-approved product.
Under current law, the Food and Drug Administration must approve all pharmaceuticals and medical devices before they can be marketed. Although the process is often termed an FDA testing program, that agency does little if any actual testing. For example, the developer of a new drug uses its own labs or hires another private company to conduct animal tests on the drug for safety before proceeding to clinical trials for safety and efficacy in people. These tests often are conducted by a medical school department or a consulting firm. When each phase of the testing is completed, the pharmaceutical company submits the details of the testing process, evidence of adherence to FDA protocols, and the test results to the FDA.
FDA officials review the test results at each step, and if they are satisfied, they give the pharmaceutical company permission to proceed to the next step in the testing process. When all the tests and trials are complete, FDA officials review all the information—often measured in hundreds of pounds or linear feet of reports rather than number of pages—and decide whether the company can market the drug and advertise it to physicians for the treatment of specific diseases and conditions. The FDA exercises very strict authority over what manufacturers can say about their products. Interestingly, over half of product uses are so-called off-label uses as physicians discover that products approved to counter one ailment can be