Oral

The panel will focus on the FDA approval process of medical devices and prescription drugs, and several weaknesses in the safeguards that are intended to ensure that approval is based on proven safety and efficacy. Panel members will discuss how political, ideological, and industry pressure can undermine the role of science at the FDA, and the implications for public health and especially women’s health. The panel will also examine how and why current regulations do not ensure that women of color are involved in clinical research trials that are the basis for FDA approval decisions.

Session Objectives: 1. Explain the FDA approval and regulatory process for prescription drugs and medical devices. 2. Describe the importance of greater participation of women of color in clinical trials. 3. Explain the impact of various internal and external non-scientific pressures on the FDA’s evidence-based decision making process. 4. Understand the conditions under which healthy women with certain risk factors are routinely offered drug interventions that may do more harm than good.

CE Credits: CME, Health Education (CHES), Nursing