Ethical Issues in the Drug Approval Process

The Food and Drug Administration’s (FDA) drug approval process carries great significance for both pharmaceutical companies and for patients. In recent decades, there has been a shift towards expedited approval so that drugs, especially those for terminally ill patients, can be brought to market faster. However, the FDA still has the responsibility of protecting patients from harm. The case studies of two drugs, Vioxx and Avastin, highlight several of the ethical and practical issues of the drug approval process, including the nature of clinical trial research, the risk-benefit analysis of new treatments, the growth of Contract Research Organizations (CROs) and the ethics of post-marketing research. In today’s rapidly advancing global society, there is grey area in terms of how to act ethically in performing research on human subjects, yet provide the drugs that patients want in a timely manner. I advocate that the FDA should take a patient centered approach to the drug approval process. First, the FDA should continue to use accelerated approval and work to streamline the approval process further, since it has been shown to benefit patients greatly. Second, the agency should continue to utilize the comprehensive informed consent process. If in the future they can eliminate the theoretical misconception about research, by better educating patients about the difference between research and treatment, only then would I advocate for streamlining or removing the informed consent process. Until then, patients need to be made fully aware of their role as a research subject