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Tuesday, June 26 • 4:15pm - 5:30pm
#278: Challenges and Opportunities in Data Access and Methodology Development for Post-Market Generic Drug Monitoring

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-606-L04-P; CME 1.25; IACET 1.25; RN 1.25

Contrary to new drug applications (NDA) that often have extensive safety and efficacy evaluations using data from three phases of clinical studies, generics are evaluated through an abbreviated application (ANDA) with a much smaller trial (mostly in healthy subjects) to demonstrate their bioequivalence to the reference listed drug (RLD). Once the generic product enters the market, there is a substantial amount of information from post-marketing or secondary data that could be utilized to compare the clinical safety and effectiveness of approved and marketed generics to the prior data from the years of marketing the brand product without generic competition.
Due to the nonrandom and retrospective nature of the secondary data, it is imperative to control confounding to reduce biases. The FDA has funded a series of external grants and contracts that address the issue of generic drug substitutability by studying the utilization and switching patterns, the role of authorized generics, FAERS data, therapeutic class substitution, and statistical methodology that deals with the temporal confounding and unbalanced data. We are currently funding studies that address the generic drug utilization in special populations such as pediatric and senior populations. We started to exploit the opportunity to use Sentinel to compare outcomes between brand and generic products. The expert panel discussion, including members from Sentinel network, Office of Surveillance and Epidemiology at FDA, and collaborators under the GDUFA regulatory science program, will share relevant experience and visions in this area.

Learning Objectives

Analyze the technical challenges involved in the comparison between the branded and generic products in post-market stage; Identify current data sources that enable post-market evaluation and quantitative approaches for signal detection; Evaluate the level of evidence associated with every study design of post-market research.


Liang Zhao, PhD


Joshua Gagne, DrSc, PharmD

Sarah K Dutcher, PhD, MS

Joseph Ross, MD, MHS


Sarah Dutcher

Epidemiologist, OSE, CDER, FDA
Sarah Dutcher is a pharmacoepidemiologist and health services researcher whose work focuses on designing studies and applying different analytic methods in secondary data to evaluate how pharmaceuticals are being used in the management of health conditions and the effects of these... Read More →

Joshua Gagne

Associate Professor of Medicine and Epidemiology, Brigham and Women's Hospital and Harvard Medical School
Joshua J Gagne is an Associate Professor of Medicine at Brigham and Women’s Hospital and Harvard Medical School and an Associate Professor in the Department of Epidemiology at the Harvard T.H. Chan School of Public Health, where he directs the Program in Pharmacoepidemiology. He... Read More →
avatar for Joseph Ross

Joseph Ross

Professor of Medicine and Public Health, Yale University School of Medicine, United States
Joseph S. Ross, MD, MHS, is a Professor of Medicine (General Medicine) and of Public Health (Health Policy and Management) at the Yale School of Medicine, an Associate Physician of the Center for Outcomes Research and Evaluation at Yale-New Haven Health System, and Co-Director of... Read More →

Liang Zhao

Director, Division of Quantitative Methods and Modeling, OGD, CDER, FDA
Dr. Liang Zhao has been serving as Director of the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS) in Office of Generic Drugs, CDER since 2015. He initially joined FDA as a clinical pharmacology reviewer in the Office of Clinical Pharmacology... Read More →

Tuesday June 26, 2018 4:15pm - 5:30pm EDT
Room 252AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Forum