FDA Voices
Ensuring Quality and Access: FDA’s Approach to Generic Drug Oversight
By: Dr. Iilun Murphy, Director Office of Generic Drugs, Center for Drug Evaluation and Research (CDER) and Dr. Mike Kopcha, Director Office of Pharmaceutical Quality, CDER
Twenty years ago, it was uncertain whether the United States would see generic competition for complex drug products such as peptides, inhalers, and other sophisticated therapies that millions of Americans depend on. In the past year, the U.S. Food and Drug Administration's generic drug program approved the first generic versions of complex inhalation products (Flovent, QVAR) and a glucagon-like peptide-1 (GLP-1) receptor agonist (Saxenda). These milestones were made possible by dedicated scientific research and regulatory innovation at the FDA. Momentum continues to build: on May 21, 2026, the FDA updated multiple product specific guidances to reduce expensive and time-consuming clinical studies needed for generic inhalation products, which could help bring more affordable options to patients sooner. The agency continues to prioritize the speed and efficiency with which generic drugs are regulated, while balancing the need for minimizing risk and ensuring access to quality medications.
Generic drugs are key to lowering costs for American patients, accounting for over 90% of prescriptions dispensed in the United States but represent less than 13% of prescription drug costs. Over the past decade, savings from generic drugs have exceeded $3 trillion. These figures reflect the critical access to life-saving medications generic drugs provide, as well as reduced financial burden on families, which can drive improved medication adherence and better health outcomes.
The FDA recognizes that anecdotes and public concerns regarding quality and supply chain of generic medications may undermine confidence in generic drugs. We welcome the public scrutiny, which can help sharpen our regulatory processes and efforts to strengthen U.S. drug supply chains, while also acknowledging that these anecdotes can omit important context, including the FDA's oversight of these products.
Generic Drug Manufacturing
Drug manufacturing is a complex process, whether at domestic or foreign facilities. The FDA's oversight of brand and generic drug manufacturing employs a comprehensive, science- and risk-based approach that begins before approval and continues throughout a drug’s lifecycle. To receive U.S. approval, generic drugs must meet the same rigorous quality standards as brand drugs, including demonstrating that they are manufactured under current good manufacturing practice (CGMP) requirements, regardless of where they are manufactured. Manufacturers must generally test their drug batches to ensure that drugs meet FDA-approved specifications before they are released for patient use; however, ensuring drug safety depends on robust oversight mechanisms beyond manufacturer self-testing, including FDA inspections and post-market surveillance.
The FDA encourages all drug manufacturers to adopt mature quality management practices that go beyond CGMP requirements. The Quality Management Maturity Program aims to foster quality culture, encourage strong quality management practices, identify improvement opportunities, and ensure reliable product supply. Mature quality management practices support a more reliable drug supply chain by reducing quality-related failures and improving the ability of establishments to maintain performance.
Inspections for Manufacturing Facilities
Manufacturing facilities undergo risk-based inspections routinely. While the COVID-19 pandemic significantly disrupted onsite inspection activities, the FDA implemented innovative approaches to maintain oversight, including expanded use of remote regulatory assessments, records requests under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act, and leveraging mutual recognition agreements with trusted global regulatory partners. Since the pandemic, the FDA has leveraged these tools alongside a risk-based approach to prioritizing drug quality inspections, and as of 2025, inspection coverage is nearing a return to pre-pandemic levels. The FDA is also increasing unannounced inspections for foreign manufacturers to redress a historical discrepancy between domestic and foreign inspections.
Onshoring of Pharmaceutical Manufacturing
The FDA strongly supports efforts to bring pharmaceutical manufacturing back to the United States because domestic manufacturing capacity is essential for supply chain security and resilience.
The COVID-19 pandemic starkly illustrated the vulnerabilities of overreliance on any single geographic region for critical medicines. The migration of pharmaceutical manufacturing overseas occurred over decades, driven primarily by economic factors. Reversing this trend will require sustained commitment and investment from industry, government regulators, and the public.
The agency is working to facilitate domestic manufacturing through innovative and proactive regulatory processes. The FDA PreCheck Pilot Program seeks to support the development of new domestic manufacturing facilities, and the new FDA ANDA Prioritization Pilot accelerates reviews for generic companies that test and manufacture their products in the U.S.
Post-Approval Surveillance to Monitor Product Quality
The FDA uses a comprehensive surveillance system combining quality and adverse event data with inspection reports, laboratory testing, manufacturing metrics, and supply chain information to monitor product quality after approval. Using this data, the agency identifies and investigates emerging quality concerns. When adverse event patterns raise credible concerns, the FDA conducts a comprehensive investigation, which may include product testing, inspections, or analyses that track which patients used which version of the drug.
Beyond facility inspections, the FDA conducts targeted testing of marketed drug products. Resource constraints prevent routine testing of all drugs, so we employ a risk-based approach that focuses on drugs with higher risk profiles and those for which we receive credible quality concerns through our surveillance systems. We also maintain robust adverse event monitoring systems that can detect signals of potential non-equivalence or safety issues, allowing us to investigate and act when problems arise.
The rise of third-party testing laboratories has added complexity to the pharmaceutical quality landscape. The agency is open to third-party testing when conducted with appropriate validated methods. However, we have significant concerns when testing uses questionable methodologies that at times have been inaccurate by orders of magnitude and have generated alarm without scientific basis. Suspected generic drug quality or safety issues should be reported to the FDA’s SmartHub to enable effective regulatory surveillance. Though generic drugs account for 90% of all prescriptions, to date they have represented only 40% of product quality defect reports received by the FDA.
Looking Ahead for the Generic Drug Program
The generic drug program is a collaborative effort across the FDA including but not limited to the Offices of Generic Drugs, Pharmaceutical Quality, Compliance, and Surveillance and Epidemiology: a testament to the FDA’s broad commitment to ensuring the quality of generic medicines for Americans.
The FDA’s accelerated review of generic applications to mitigate drug shortages has been effective. There were only four new shortages in 2025, down from a peak of 251 in 2011. The agency remains committed to ensuring all drugs marketed in the United States, whether brand or generic, domestically manufactured or imported, meet rigorous quality standards. The FDA will continue to advance regulatory processes and act when documented quality issues arise. We look forward to working together with all interested parties to strengthen the generic drug program through evidence-based policies and actions that ensure quality and access for all Americans.
We invite you to join us at our annual GDUFA Science and Research Public Workshop, June 8-9, 2026, where multiple interested parties, especially patients, will help shape the next frontier of generic drug science.
Please visit our updated Q&A webpage for more information on generic drugs.