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FAQs and Data on File

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Documents known as Frequently Asked Questions (FAQs) are used by call center staff as they answer questions from health care professionals and the public. FAQs are commonly prepared for each drug product; some companies use them for experimental drugs still in clinical development. FAQs need to be accurate and up-to-date. Dr. Wells has experience in creating FAQs and managing their updates for eight years. As a medical communciations professional, he is aware of the regulatory boundaries that define what can and cannot be answered and also what information is suitable for the public versus health care professionals.

A recent project was to update an existing FAQ document for a marketed drug using the latest known clinical and analytical information. Categories for questions were reviewed and updated, and this document was made more consistent and uniform in its responses. In the United States it is common to use “data on file” to answer questions for clinicians. Dr. Wells has reviewed all questions that referenced data on file and made sure the data were found in company documents; if not, those responses were removed because they had no valid documentation. Outside the U.S., it is now common practice NOT to rely on ANY “data on file” sources for the response. Dr. Wells recently compiled a new version of the FAQs intended for international use and removed all data that were not from published or publicly available sources.  It is important to represent a drug product accurately in call center responses and also to comply with country regulations; Dr. Wells can assist with these type of projects as a Subject Matter Expert, pharmacist, toxicologist and analytical scientist.

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