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Marshfield Clinic-led researchers to study generic drugs, adverse events via FDA grant

​​Dec. 9, 2015​

​​​​Marshfield Clinic Research Institute (MCRI) has been awarded a contract, including future options valued at $3.1 million, through the U.S. Food and Drug Administration (FDA) and Department of Health and Human Services to study the effects of generic drugs in the marketplace.

“Our primary goal is to detect generic-specific or generic-enhanced drug adverse events early so problem drugs can be evaluated and removed from the marketplace earlier, ultimately, to save lives,” said Dr. Peggy Peissig, principal investigator of the study and director, Biomedical Informatics Research Center, MCRI. “Marshfield is well suited for this research because of its longstanding and comprehensive electronic health record (EHR), mainly stable patient population and robust insurance data provided by Security Health Plan of Wisconsin, Inc.”

Peissig will lead a team of study researchers that includes Dr. Michael Caldwell and Richard Berg, MCRI; Dr. David Page, University of Wisconsin-Madison; and Drs. Rick Hansen and Brent Fox, Auburn University. They will develop a surveillance system for early detection of adverse drug events (ADEs) for generic products. The team will use state-of-the-art data mining approaches to detect differences in outcomes between brand and generic drugs and predict patients at risk of experiencing a generic drug adverse outcome. 

Generic pharmaceutical products play an important role in controlling health care costs, with prices that are typically 20-90 percent cheaper than brand equivalents. Since 2007, generic drug savings have increased 17 percent annually, with net savings of $254 billion in 2014 and a total savings in the last 10 years of $1.68 trillion, according to Generic Pharmaceutical Association. 

The FDA requires demonstration of pharmaceutical equivalence including active ingredient(s) sameness, bioequivalence and other regulatory requirements before approval of a generic drug product through an Abbreviated New Drug Application. However, most of the time, generic drugs are not required to demonstrate equivalence with inactive ingredients. Further, because safety and effectiveness already have been established by the brand-name drug, clinical data for the generic drug are not required for this purpose. Historically, differences in safety or effectiveness have been observed in limited cases, with these differences attributed to variations in generic formulations.

​“This work is needed to address gaps in knowledge surrounding generic drug use,” Peissig said. “We have limited evidence about the long-term clinical effects of generic drugs compared to brand-name drugs. We plan to use state-of-the-art data mining approaches to learn about these differences and to build a detection system that can alert us to potential harmful effects. Therefore, problem drugs can be more quickly identified, evaluated and addressed to prevent subsequent adverse events.”

This project will culminate in creating an integrated system that sifts through data captured in an integrated electronic health record (EHR) and claims database that detects potential generic drug-specific ADEs or differences in generic drug efficacy, in comparison to the brand name drug, for expert evaluation and attribution. The post-market surveillance system will be developed and tested using data from Marshfield Clinic’s EHR and Security Health Plan’s claims repository and then replicated in the Innovation in Medical Evidence Development and Surveillance (IMEDS) laboratory. 

Marshfield Clinic Research Institute (MCRI), a division of Marshfield Clinic, was founded in 1959. It’s the largest private medical research institute in Wisconsin. MCRI​​​​ consists of research centers in clinical research, agricultural health and safety, epidemiology, human genetics, biomedical informatics and dental informatics. Marshfield Clinic investigators publish extensively in peer-reviewed medical and scientific journals addressing a wide range of diseases and other health issues, including cancer, infectious diseases, heart disease, diabetes, eye disease, neurological disease, pediatrics, radiology, women's health, agricultural safety and genetics. 

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