Pharmaceutical Company Faces Scrutiny Over Suboxone Film

A pharmaceutical company faces allegations of misleading claims about a medication for opioid addiction, prompting an expert investigation into its formulations.

ByWendy Ketner, M.D.

Published on

Suboxone

Case Overview

This case revolves around a pharmaceutical company that developed a medication known as Suboxone, which is utilized to assist individuals grappling with opioid addiction. Allegations have arisen suggesting that the pharmaceutical company fabricated claims regarding the superiority of Suboxone Film compared to its tablet counterpart. The intent behind these claims is believed to be a strategy to obstruct the entry of generic alternatives into the market. To investigate these allegations, an expert in the pharmaceutical sector, particularly regarding opioids and Suboxone, is sought to provide insight into industry publications and analyses that could clarify whether the film formulation indeed offers any advantages over the tablet version.

Questions to the Pharmacy expert and their responses

Q1

Please describe your experience in the pharmaceutical industry, as it pertains to opioids and Suboxone.

I am a licensed Pharmacist (PharmD-2004) with 18 years of experience. I am also trained in clinical pharmacology and pharmaceutical sciences (PhD-2009) and I have 12 years of experience as a faculty member. I am an endowed professor and director of a clinical pharmacology research laboratory and a geriatrics pharmacotherapy program. I can offer assistance with strategy and research.

Q2

If retained, would you be able to review industry publications and render an opinion on whether Suboxone film is superior to the tablet version of the drug?

I would pull the literature describing the pharmacokinetics of the Suboxone film and tablets, respectively. I am an expert on evaluating how drugs work in people. I would be happy to discuss this case with you further and lend my expertise.

About the expert

This expert has over 15 years of experience in the field of clinical pharmacy. He obtained both his BS in pharmacy and his PharmD from the Florida Agricultural and Mechanical University, before receiving his PhD in clinical pharmaceutical sciences and pharmacogenomics from the University of Florida. Today, he is a licensed registered pharmacist in the states of Arkansas and Florida. Additionally, this expert is an active member of numerous professional organizations, including the American Pharmacists Association, the American College of Clinical Pharmacy, and the American Society for Clinical Pharmacology and Therapeutics. He is also very active in academia, having received several grants for his research on pharmacogenetics in elderly patients. Moreover, he has published numerous peer-reviewed works and has presented on various topics related to pharmacology. This expert previously served as a staff pharmacist at Shands at UF Hospital, as an intermittent pharmacist at the NF/SG VA Health System and the McClellan Memorial VA Health System, and as an assistant professor of pharmaceutical sciences at the University of Arkansas. Currently, he serves as the director of the geriatric pharmacotherapy program, as the director of the clinical pharmacology research laboratory, and as an associate professor & endowed professor of pharmacotherapy and outcomes science at a major university in Virginia.

Expert headshot

E-423332

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About the author

Wendy Ketner, M.D.

Wendy Ketner, M.D.

Dr. Wendy Ketner is a distinguished medical professional with a comprehensive background in surgery and medical research. Currently serving as the Senior Vice President of Medical Affairs at the Expert Institute, she plays a pivotal role in overseeing the organization's most important client relationships. Her extensive surgical training was completed at Mount Sinai Beth Israel, where she gained hands-on experience in various general surgery procedures, including hernia repairs, cholecystectomies, appendectomies, mastectomies for breast cancer, breast reconstruction, surgical oncology, vascular surgery, and colorectal surgery. Dr. Ketner also provided care in the surgical intensive care unit, further enhancing her clinical expertise.

Her research interests have focused on post-mastectomy reconstruction, surgical treatment of gastric cancer, including co-authoring a textbook chapter on the subject, and research on the percutaneous delivery of stem cells following myocardial infarction. Dr. Ketner's educational background includes a Bachelor's degree from Yale University in Latin American Studies and a Doctor of Medicine (M.D.) from SUNY Downstate College of Medicine. Additionally, she contributes her medical expertise as a member of the Board of Advisors for Opollo Technologies, a fintech healthcare AI company. At Expert Institute, her role involves leveraging her medical knowledge to provide insights into legal cases, underscoring her unique blend of medical and legal acumen.

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