Challenges and Opportunities in Data Access and Methodology Development for Post-Market Generic Drug Monitoring
Liang Zhao, PhD
Director, ORS, DQMM, Office of Generic Drugs, CDER
FDA, United States
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 Objective : Demonstrate a technical appreciation of 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.
FDA, United States