Investigating Generic Drugs: Mending the Tattered Safety Net of the FDA

Peter Baker

President, Live Oak Quality Assurance and Former FDA Inspector

Baker spent 11 years as a U.S. FDA Drug Investigator; he was named investigator of the year in 2013 for his inspections of nearly 50 overseas generic plants that resulted in landmark findings and the restriction of overseas products. Today, as president of Live Oak Quality Assurance, Baker works to improve the quality of medicines by providing training and consulting services to organizations to improve their data processes. The story of his FDA work was featured prominently in Katherine Eban’s award-winning book, Bottle of Lies. He has also testified before Congress on the topic of FDA inspections.

Rosemary Gibson

Author, China Rx: Exposing the Risks of America's Dependence on China for Medicine

Gibson is an influential author and lecturer who has received the American Medical Writers Association’s highest honor for her contributions to reporting on critical health issues, as well as the Lifetime Achievement Award from the American Academy of Hospice and Palliative Medicine. Her recent work documenting harm caused by generics builds public awareness, which she hopes to harness to drive concrete change.

John Gray, PhD

Dean’s Distinguished Professor, Department of Operations and Business Analytics, Ohio State University

Gray’s award-winning research explores how generic drugs are made, revealing the production and supply chain decisions that make a meaningful difference in quality, along with possible improvements to the industry. He has published multiple papers on the subject and currently has a Department of Defense grant to create a quality score system that would give consumers more transparency as they make purchase decisions.

Suzanne Robotti

Founder and President, MedShadow Foundation

Suzanne Robotti founded MedShadow Foundation in 2013. As a patient safety advocate, Robotti served on the FDA Advisory Committee on Drug Safety and Risk Management as the only consumer representative alongside doctors and pharmacists from 2017-2024. She writes and speaks extensively on known and lesser-known side effects, interactions, and supply chain issues related to OTC and prescription drugs.