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Does Bioequivalent Always Mean Therapeutically Equivalent? Impact of FDA’s Proposed Rule on Generic Labeling
Session Chair(s)
Margaret Woo, PharmD, MS
Director, Global Regulatory Affairs, Oncology
EMD Serono, United States
A panel claimed that FDA failed to sufficiently monitor generics which account for 85% of drugs sold in US. This session will discuss a new proposed rule which makes it easier for generic companies to update labels, and how this change will have implications on the Federal Food, Drug and Cosmetic Act (FD&C Act), generic companies, patients, and health care providers.
Learning Objective : Describe how the current abbreviated new drug application (ANDA) approval process may have gaps in ensuring safe and effective continual use of generic drugs for patients; Identify the limitations and hurdles to implement FDA’s proposed rule on generic labeling by updating generic labels with newly acquired safety data without being approved by FDA first; Discuss the implications of the rule on the generic industry, patients and health care providers.
Speaker(s)
The Path: Through the US Supreme Court – Leading Up To FDA’s Proposed Rule
Kurt R. Karst, JD
Hyman, Phelps & McNamara, PC, United States
Director, Prescription Drugs and Biologics, Corporate Transactions, Enforcement
Why the FDA Proposed Rule on Drug Labeling Puts Safety and Savings at Risk
Christine Simmon, JD
The Biosimilars Council, United States
Executive Director
Finding a Road to Finalization that Protects Patients
Jeffrey K. Francer, JD
Eli Lilly and Company, United States
Vice President, Head of Global Regulatory Policy and Strategy
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