Impact of Regulatory Policy Changes on Generic Drug Prices in the United States

Abstract

Introduction: Generic Drug User Fee Act (GDUFA) was introduced in 2012 to bring more and more generic drugs into the market in a short time through an effective review process. In the present study, the impact of the GDUFA on prices of the generic drugs has been evaluated. Materials and Methods: Various research reports related to drug costs and competition such as (i) reasons for high drug prices, (ii) FDA’s research on drug prices pre-and post-GDUFA, and (iii) the current status of generic drugs in the USA produced by different agencies including the Congressional Budget Office (CBO), FDA’s Center for Drug Evaluation and Research (CDER), and the Federal Trade Commission (FTC) to understand the challenges of high drug costs have been critically evaluated. Results and Discussion: The analysis of research reports generated over some time concludes that the fall in generic drug prices has been accelerated further in recent years, with increased competition. The data analysis also reflects that during the GDUFA period, the Agency has been able to proactively address the challenges posed by brand-product companies. However, some issues remain to be addressed. Conclusion: The scope of this evaluation was limited to focus on FDA-related aspects where generic competition can be enhanced by making the generic drug approval process more efficient, continue to facilitate industry on complex products regulation to bring generic equivalents of complex products where patents expired long-time back, help resolve shortages faster and help expedite resolution of site compliance matters more quickly to assist in resuming supplies.