By: Sally Choe, Ph.D., Director, Office of Generic Drugs, Center for Drug Evaluation and Research
Providing patients and consumers greater access to safe and effective medicines is a public health priority for the U.S. Food and Drug Administration. The FDA’s Office of Generic Drugs (OGD) has a mission to help ensure high-quality, affordable generic drugs are readily available. Currently 90% of all prescriptions dispensed in the U.S. are for generic drugs. To support the availability of generic drugs, the generic drug program approves safe, effective, high-quality drugs and monitors those drugs once they are on the market.
2021 was another successful and productive year in pursuit of this mission and the OGD annual report, published today, captures these achievements. The FDA’s generic drug program approved hundreds of generic drug applications, known as abbreviated new drug applications (ANDAs), and thousands of supplements to already approved ANDAs. The FDA prioritized the assessment of generic drug application submissions for drugs identified as potential treatments and supportive therapies for patients with COVID-19. COVID-19 related submissions included more than 75 original ANDAs, some which we approved in record time, as well as more than 1,200 supplemental applications. We funded approximately $20 million in generic drug science and research programs. We also issued 149 product-specific guidances for generic drug development (PSGs), including 54 PSGs for harder-to-develop complex drugs, to relay the agency’s thinking on the most appropriate methodology and evidence needed to support the development of specific generic drugs.
Innovation Ensured the Public’s Access to More Affordable Medicines
In 2021, innovative OGD research supported the work of the generic drug program. For instance, we established the scientific foundation to support alternative bioequivalence (BE) approaches for several generic drug products, including a novel in vitro BE approach that enabled the efficient development, assessment, and approval of the first generic difluprednate ophthalmic emulsion (generic Durezol) to treat eye swelling and pain after eye surgery.
Another innovation came with the approval in 2021 of the first generic paliperidone palmitate extended-release injectable suspension (generic Invega Sustenna), a long-acting injectable product indicated for the acute and maintenance treatment of schizophrenia in adults. The FDA developed modeling and simulation approaches for pharmacokinetic study designs and BE evaluations. The applicant applied the new approaches to the studies before submitting the application to the FDA.
In another example, we approved the first complex generic for ferumoxytol injection (generic Feraheme), a parenteral iron product that treats iron deficiency anemia. Our scientific investment in the characterization and advanced BE study designs was essential to this approval.
Scientific and Regulatory Collaboration Moved the Needle
Scientific and regulatory collaborations helped us create new approaches to support timely assessment and approval of many generic drug products in 2021.
The FDA, in partnership with the University of Maryland and the University of Michigan (the Center for Research on Complex Generics), collaborated to reach thousands of stakeholders worldwide with workshops that stimulated dialogue and generated knowledge about science and innovative research crucial for the development of complex generic medicines.
Additionally, the continued implementation of the congressionally established Competitive Generic Therapy (CGT) program helped us reach a milestone in 2021 – approving 100 ANDAs for drugs designated as CGTs. The CGT pathway for generic drugs helps incentivize the entry of drugs with “inadequate generic competition” to the market. This milestone is a sign the program is achieving its goal – the development and market availability of safe, effective generic drugs in areas of the market that previously had little to no competition.
Globally, our collaborative work included the launch of a joint FDA and European Medicines Agency pilot program to provide parallel scientific advice to developers of complex generic drug products. The pilot program allows assessors from the two agencies to concurrently communicate their views on scientific issues, in real time, to manufacturers working to develop complex generic drugs. This can help shorten the time it takes for these important products to obtain regulatory approval. The FDA also launched the Global Generic Drug Cluster, the first forum for leading regulatory agencies to increase scientific alignment around topics relevant to generic drug development.
In 2021, even with the unique challenges caused by the ongoing pandemic, OGD continued to innovate and conduct scientific research to keep the FDA generic drug program moving forward. As a results-driven organization, we engage the best experts, we emphasize best practices, and we translate research into actionable guidance. We are excited about the year ahead, and we anticipate a continuation of program growth throughout 2022.