Reforming the FDA: Saving Money, Saving Lives
The Food and Drug Administration (FDA) is responsible for the approval and regulation of prescription drugs, tobacco products, medical devices, and food items. With a $5.7 billion budget for fiscal year (FY) 2019 ($2.6 billion from various user fees), the agency falls short in providing Americans adequate access to the products they need or want. The prescription medication approval process remains languid and demands increasingly-outdated statistical guidelines from drug sponsors. The agency’s “tobacco product” evaluation process focuses more on fear and risk-aversion than evidence-based policy making, and bizarrely includes products such as electronic cigarettes that do not contain tobacco. The FDA often has food guidelines based on politics and hysteria rather than science.