FDA policy on unapproved drug products: past, present, and future

Abstract

Objective: To review the history of drug regulation by the Food and Drug Administration (FDA) as it relates to unapproved drugs and FDA policy, along with the FDA's efforts to avoid future incidents by amending and enforcing those policies that are already in place.

Data sources: Data from FDA history documents, FDA guidances, Code of Federal Regulations Title 21, and presentations by the FDA's Office of Compliance were gathered.

Study selection and data extraction: All information identified from the data sources was evaluated, and all information deemed relevant was included for this review.

Data synthesis: Contrary to popular belief, there are drugs on the market that have not been evaluated for safety or efficacy by the FDA. For almost a century, the FDA has taken action against public health threats posed by unapproved drug products, and today's drugs and vaccines are required to demonstrate both safety and efficacy prior to marketing. The FDA has taken great strides to ensure the welfare of Americans by reacting to disasters that have occurred in the past and being proactive by setting regulations that will prevent such catastrophes from occurring in the future.

Conclusions: The FDA recognizes that drug regulation is an ongoing process and that, although we have come a long way, there is still much to be done.