FY2019 GDUFA Science and Research Report

Research Topics:

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Joint Directors’ Message from Sally Choe, Director of CDER’s Office of Generic Drugs and Michael Kopcha, Director of CDER’s Office of Pharmaceutical Quality

The Generic Drug User Fee Amendments (GDUFA) established a research program that is implemented through extensive collaborations both within and outside FDA. This Directors’ Message is a joint message from the Directors of the Center for Drug Evaluation and Research (CDER) Office of Generic Drugs (OGD) and Office of Pharmaceutical Quality (OPQ), as both offices are significantly involved in GDUFA-funded research collaborations and projects. CDER’s Office of Translational Sciences, the FDA Center for Devices and Radiological Health, and the National Center for Toxicological Research, are also closely involved with the GDUFA Science and Research program.

Our GDUFA-funded research collaborations have resulted in significant accomplishments in developing the scientific basis supporting new and revised guidances for industry and in refining methods for the scientific evaluation of equivalence for generic drug products.

In Fiscal Year 2019 (FY2019), FDA awarded 14 new research contracts and 3 grants for innovative research projects on generic drugs. FDA also utilized its laboratories and in silico resources to conduct more than 50 GDUFA Science and Research projects. These research projects follow the FY2019 science priorities, which fall into the following categories:

Complex active ingredients, formulations, or dosage forms
Complex routes of delivery
Complex drug-device combination products
Tools and methodologies for bioequivalence and substitutability evaluation

Our GDUFA-funded research provided the necessary data to support the assessment and approval of multiple Abbreviated New Drug Applications (ANDAs) for complex generic products. These are drugs that by their nature are harder to “genericize” using traditional approaches. Laboratory research into analytical technologies and in vitro approaches supported the approvals of first generics for complex products including Sevelamer Hydrochloride Tablets, Acyclovir Cream and Fluticasone Propionate/Salmeterol Inhalation Powder. FDA research on modeling of drug delivery aids FDA decision-making and models are beginning to be included in ANDA submissions. In 2019, the physiologically-based pharmacokinetic modeling included in an ANDA supported an approval for a locally acting drug (Diclofenac Topical Gel) based on an efficient alternative bioequivalence approach.

Scientific data and knowledge gained from the GDUFA Science and Research program support our regulatory advice and decision-making across the generic drug program. Our research activities have contributed to the development of general guidances and product-specific guidances (PSGs), assessment and approval of ANDAs, and informed communication with industry prior to filing a submission, also known as the pre-ANDA stage.

In FY2019, we issued 252 new and revised PSGs, which provides recommendations for developing generic drugs and generating the evidence needed to support ANDA approval, thereby helping to streamline generic drug product development by industry and application assessment by FDA.

Complex generic products are typically harder to develop, which means that many complex products face less competition than other products, and therefore can be more expensive and less accessible to the patients who need them. To help address these issues, FDA engages with industry through pre-ANDA meetings related to complex products and received 112 pre-ANDA meeting requests in FY2019.

Our report provides detailed results for 13 areas of focus, including research activities and comprehensive lists of grants and contracts that the GDUFA Science and Research program awarded in FY 2019. We also provide detailed lists of journal articles, posters, and presentations given in FY19 on our website. Additional information on outcomes from the GDUFA Science and Research program will be shared in the FY19 Outcomes Report once available.

We want to thank our external and internal collaborators who contributed greatly to this effort and look forward to the future scientific achievements that will help enhance access to generic drugs for the American public.