Auburn University researchers study success and safety of generic drugs with FDA grant

Published: November 13, 2014
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AUBURN UNIVERSITY – Two Auburn University researchers will study the efficacy and safety of generic drugs with a $400,000 grant from the U.S. Food and Drug Administration. Richard Hansen and Jingjing Qian, of the Harrison School of Pharmacy's Department of Health Outcomes Research and Policy, recently received the two-year grant to support their studies.

Hansen says generic pharmaceuticals, including a special kind of generic known as an authorized generic, help to control health care costs. While that is generally accepted, little post-market research has compared the benefits, harms, usage and substitution patterns of authorized generics, other generics and brand drugs. This study uses post-market data sources and methods to develop a pilot surveillance system that evaluates how utilization and outcomes compare for authorized generics, other generics and brand drugs.

"Generic drugs play a very important role in controlling healthcare costs, but questions often arise from health care providers and patients as to whether generic drugs truly have the same outcomes as their more expensive branded counterparts," Hansen said. "This work complements current FDA post-market safety and surveillance activities to ensure the drugs act in the same way by comparing the real-world efficacy, or effectiveness, and safety profiles of generic drugs, authorized generics and brand drugs.

"Results of this work will allow us to either conclude that generic drugs do indeed result in similar outcomes or identify clinical scenarios which may warrant more careful substitution."

The project is titled "Post-market Authorized Generic Evaluation." The studies will be performed by a consortium that includes investigators at Auburn University, the University of Wisconsin, the Marshfield Clinic Research Foundation and the Massachusetts College of Pharmacy and Health Sciences.

The study will assess the utilization and outcomes for brand, authorized generic and other generic drugs. Included in that is an evaluation of product switching and switch-back rates. It will also assess the market-level safety associated with entry of authorized generics and independent generics. Along with the two assessments, the study will create a pilot system for safety surveillance of generic drugs.

The award is for $200,000 in the first year with an additional $200,000 available in the second year, depending on funding availability and project progress.

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