Author: Sally Choi, Ph.D., Director of General Medicine, Center for Drug Evaluation and Research

Providing patients and consumers with greater access to safe and effective drugs is a public health priority for the U.S. Food and Drug Administration. The FDA’s Office of Generics (OGD) has a mission to ensure the availability of high-quality and affordable generics. Currently, 90% of all prescriptions available in the U.S. are for generics. To maintain the availability of generics, the generics program approves safe, effective, high-quality drugs and monitors these drugs as soon as they appear on the market.

Sally Choi, Ph.D.
Sally Choi, Ph.D.

2021 has been another successful and productive year in achieving this mission, and the annual OGD report published today captures these achievements. The FDA’s Generics Program has approved hundreds of generics known as abbreviated new drugs (ANDAs), and thousands of supplements to already approved ANDAs. The FDA has given priority to evaluating generic drug applications for drugs identified as potential treatments and supportive therapies for patients with COVID-19. Applications related to COVID-19 included more than 75 original ANDAs, some of which we approved in record time, as well as more than 1,200 additional applications. We have funded about $ 20 million in research and development programs in generics. We also released 149 recommendations for specific generic development products (PSGs), including 54 PSGs for more complex drugs that are more complex to develop, to convey the agency’s views on the most appropriate methodology and evidence needed to support generic-specific development.

Innovation has provided public access to more affordable medicines

In 2021, OGD’s innovative research supported the work of the generics program. For example, we have developed a scientific basis to support alternative approaches to bioequivalence (BE) for several common drugs, including a new in vitro BE approach that has effectively developed, evaluated and approved the first generic ophthalmic emulsion generic with difluprednate (generic treatment Durez and postoperative pain.

Another innovation came with the approval in 2021 of the first injectable suspension with prolonged release of paliperidone palmitate (generic Invega Sustenna), a long-acting injectable product designed for the acute and supportive treatment of schizophrenia in adults. The FDA has developed approaches to modeling and simulations for pharmacokinetic studies and BE evaluation. The applicant applied new approaches to research prior to applying to the FDA.

In another example, we approved the first set of generics for injection of ferumoxytol (generic Feraheme), a parenteral iron preparation that treats iron deficiency anemia. Our scientific investment in the characteristics and advanced design designs of BE was necessary for this approval.

Scientific and regulatory cooperation has driven the needle

Scientific and regulatory collaboration has helped us create new approaches for the timely evaluation and approval of many generic drugs in 2021.

The FDA in partnership with the University of Maryland and the University of Michigan (Center for Integrated Generics Research) is collaborating to reach thousands of stakeholders around the world by conducting seminars that stimulate dialogue and generate knowledge about science and innovation research relevant to complex drug generators.

In addition, the continued implementation of the Congressional Competitive Generic Therapy (CGT) program has helped us reach the milestone of 2021 – the approval of 100 ANDAs for drugs designated as CGT. The CGT pathway for generics helps stimulate the market entry of drugs with “inadequate competition”. This milestone is a sign that the program is achieving its goal – the development and availability of safe, effective generics in those areas of the market where previously there was virtually no competition.

Globally, our joint work has included the launch of a joint pilot program between the FDA and the European Medicines Agency to provide parallel scientific advice to developers of complex generic medicines. The pilot program allows evaluators from two agencies to simultaneously communicate their views on real-time scientific issues to manufacturers working on complex generic development. This can help reduce the time required to obtain these important regulatory approval products. The FDA has also launched the Global Generic Drug Cluster, the first forum for leading regulators to increase scientific alignment on topics relevant to generic development.

In 2021, even with the unique challenges posed by the protracted pandemic, OGD continued to innovate and conduct research to continue advancing the FDA’s generics program. As a results-oriented organization, we attract the best experts, focus on best practices and translate research into effective recommendations. We look forward to next year and we expect the program’s growth to continue in 2022.