FDA Science, Research, and Collaboration Advance Generic Medicines
By: Iilun Murphy, M.D., Director, Office of Generic Drugs, Center for Drug Evaluation and Research
Generic drugs play a critical role in the U.S. health care system and allow patients greater access to needed medicines. The approval of generic drugs often means multiple manufacturers for medicines, which can help stabilize the supply chain and reduce risks from drug shortages. Americans may recognize the U.S. Food and Drug Administration’s regulatory role in approving generic drugs, but few may know our work to advance generic drug development and assessment through our regulatory science and research programs. We conduct, support, and encourage scientific research on new methods to help us assess generic drug applications, and we promote innovation that leads to the development of new and often more streamlined approaches for making generic medicines. Here are some highlights from the newest edition of the Office of Generic Drugs Annual Report.
Reauthorization of the Generic Drug User Fee Amendments
Congress enacted the Generic Drug User Fee Amendments (GDUFA) in 2012, and authorized the third iteration of GDUFA (GDUFA III) in October 2022, following negotiations between the FDA and industry, along with input from public stakeholders. The GDUFA program is designed to help ensure patient access to high-quality, safe, and effective generic medicines, and to enable industry and the FDA to carry out their important work advancing generic drug development and approval.
Under GDUFA III in 2023, the FDA continued critical scientific research and expanded the number of scientific meetings available to companies seeking to submit abbreviated new drug applications (ANDAs), in particular for those working on harder-to-develop complex generic drug products.
Scientific Research Advanced Generic Medicine Development
The FDA’s generic drug science and research efforts help ensure regulatory standards, recommendations, and decisions that impact generic drugs are supported by current scientific insights and research tools. Each year, the FDA obtains public input, which helps the generic drug program identify regulatory science and research priorities that can expand and accelerate patient access to generics. The FDA then advances research in those scientific areas and publishes reports describing the corresponding activities and outcomes.
In 2023, GDUFA-funded research helped expand our understanding of generic drug products, including complex products, and contributed to the development of advanced methods to characterize product quality and performance. These methods can play a critical role in determining how the FDA assesses the bioequivalence and quality of complex generic medicines, and they can establish the scientific basis for novel and more efficient paths to develop new generic medicine products.
ANDAs and First Generic Approvals
In 2023, the FDA continued to apply our rigorous review process for generic drug approvals and approved or tentatively approved 956 ANDAs including 90 first generics. For example, we approved the first generic naltrexone extended-release injectable suspension (referencing Vivitrol). This vital medicine addresses two major public health needs affecting millions of individuals in the U.S.: treating alcohol dependence and preventing opioid dependence relapse. It is a complex, long-acting, injectable drug product that uses biodegradable polymer-microsphere technology. The development, manufacture, and regulatory assessment of these biodegradable microspheres is generally more complicated than for a daily oral tablet, therefore, the FDA’s assessment of the generic drug application had greater complexity.
International Collaboration
As a global leader in generic drug regulation, the FDA Office of Generic Drugs collaborates with foreign regulatory authorities to foster the development of uniform, scientifically driven recommendations and guidelines that can help improve the efficiency of generic drug development by, among other things, preventing unnecessary duplication of studies and testing. In 2023, the FDA announced the availability of a harmonized draft guidance for generic drugs on bioequivalence for immediate-release solid oral dosage forms. Harmonization activities like this can help regulatory agencies with timely authorization and increase availability of quality, safe, and effective generic drugs that benefit patients. In partnership with the Office of Global Policy and Strategy and others, we will continue to explore opportunities with foreign regulatory authorities that strengthen regulatory systems in the oversight of generic medicines.
Looking to the Future
The FDA Office of Generic Drugs will continue to focus on operational modernization, workforce excellence, timely approval of generic medicines, and activities that advance the development and assessment of complex generics. We look forward to communicating through conferences and online education, engaging with generic drug stakeholders, and meeting our overall GDUFA program goals. The Office of Generic Drugs 2023 Annual Report provides a comprehensive look at what we accomplished in 2023 and illustrates how the agency is well-positioned to continue this critical work in 2024.