Impact of generic drug user fee act and other initiatives on generic drug approval process in the USA

Introduction: Regulations of the drug approval process either new drug or generic has come a long way. Hatch-Waxman Act was one of the most important milestones in the drug regulations history of the USA, followed by various acts such as the Prescription Drug User Fee Act and Generic Drug User Fee Act (GDUFA). Methods: In this study, various data related to generic drug submission and approval were evaluated and critically reviewed, specifically impact of GDUFA II. Results and Discussion: Although the first 5-year term of GDUFA, i.e., GDUFA I was majorly known for clearing backlog at the Food and Drug Administration (FDA), enhancing resources, and putting processes in place, it is the second 5-year term, GDUFA II, which is expected to bring the real benefit to industry in the form of higher-number and faster approvals, including increased first-cycle approvals. Apart from reduction in abbreviated new drug application approval times, more focus has also come on approval of first generic, complex products, increased FDA-Industry meetings to resolve complex matters, and reforms on review of DMFs. Conclusion: GDUFA legislation is credited for giving push to the availability of generic drugs by increased competition and it now helps save more than USD 300 Bn annually for the American healthcare system.

Automated summary

GDUFA II brings more and faster approvals, including increased first-cycle approvals. The legislation also focuses on approving the first generic and complex products, increasing FDA-industry meetings to resolve issues, and reforming the review of drug master files. The GDUFA legislation promotes the availability of generic drugs through increased competition and saves over USD 300 billion annually for the American healthcare system.