Expert in Over-the-Counter Drug Labels Opines on Warning Standards

ByVictoria Negron

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Updated onFebruary 1, 2018

Expert in Over-the-Counter Drug Labels Opines on Warning Standards

This case involves an individual who’s chronic multiple sclerosis allegedly worsened after she took an over the counter diarrhetic. She was prescribed the diarrhetic by her doctor, and after taking the drug, she suffered from involuntary muscle movements and could not feel her legs. Her doctors have testified that they were unaware of any potentially adverse effects on her multiple sclerosis. An expert in over-the-counter drug labels was sought to opine on the manner in which information should be disseminated to the medical community concerning these drugs.

Question(s) For Expert Witness

1. Please describe your experience reviewing OTC warning labels.

2. In your experience, what is the manner in which information is disseminated to the medical community concerning these drugs?

Expert Witness Response E-188699

inline imageI have been involved in over-the-counter (OTC) regulation for over 25 years. I have extensive experience in the OTC Monograph system, switching drugs from Rx to OTC status, and translating Rx labeling to Drug Facts. I have developed OTC labeling for Rx-to-OTC switch products, and have been involved in consumer behavior testing of Drug Facts elements.

inline imageThe primary communication tool for OTC drug products is the Drug Facts labeling. This applies to physicians as well as consumers. Most of the communication between OTC drug manufacturers and the medical community is passive. Although not all OTC drug products are actively detailed to the medical community, there are a variety of sources in which both the medical community and consumers are educated about OTC drugs. For example, all OTC drugs are registered with the FDA and their labeling is published on DailyMed which is a National Library of Medicine website. Almost all OTC drug products bear a "Question?" section in Drug Facts, which provides a telephone number, and often times a website, to which questions can be addressed to the manufacturers or distributor. If there is a serious medical issue, the FDA can issue alerts on their website and require companies to send out a Doctor Letter. Information about OTC drugs are also disseminated at various medical conferences (commercial booths) and appear in a variety of medical websites (e.g., WebMD, etc.) which are widely available.

About the author

Victoria Negron

Victoria Negron

Victoria Negron has extensive experience in journalism and thought leadership in the legal space, with a background crafting content, whitepapers, webinars, and current event articles pertaining to the role of expert witnesses in complex litigation matters. She is a skilled professional specializing in B2B product marketing and content marketing. Currently, she serves as an Enterprise Product Marketing Manager at Postman, and previously held the position of Technical Product Marketing Manager at Palantir Technologies, where she developed her skills in launch strategies, go-to-market strategy, and competitive analysis.

Her expertise in content marketing was further refined during her tenure at the Expert Institute, where she progressed from a Marketing Writer to Senior Content Marketing Manager, and eventually to Associate Director of Content & Product Marketing. In these roles, she honed her abilities in digital marketing, SEO, content strategy, and thought leadership.

Educationally, Victoria holds a Master of Business Administration from the University of Florida - Warrington College of Business and a Bachelor of Arts in Literature, Art, and Hispanic Studies from Hamilton College. Her diverse educational background and professional experience have equipped her with a robust skill set in product marketing, content development, and strategic marketing initiatives.

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