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

Drug Labeling Expert WitnessesThis 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

I 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.

The 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.

Expert Witness Response E-023161

I have experience with warning labels and all the information sponsors are required to provide companies. If a drug is considered to be safe, it is designated over-the-counter (OTC). In my experience, the official way information is disseminated to the medical community is through the product label. It falls on the company to inform the FDA and make their labels accordingly, and the company’s data should prove the label accurate. If the FDA doesn’t know about a potential concern, they cannot take action. The FDA cannot modify a label based on information they have. The questions that should be asked here are: What did the company know, and when did they know it? What should they have known and when should they have known it? What should they have done and when should they have done it?


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