his is the first of a three part series on the value of disclosure of postmarketing safety information by pharmaceutical manufacturers.
Spontaneous postmarketing safety data is typically kept confidential (there is no requirement for manufacturers to disclose data directly to the public) and only disclosed in a difficult to use format when a new safety issue is communicated in the product labeling or a letter to health professionals.
Fiore Healthcare Advisors believes that postmarketing safety data are valuable even in the absence of “signals” and that the healthcare community would be well served to have increased access to usable postmarketing safety information. How would communication of the absence of signals be beneficial? This series will describe three ways, here is the first:
Provision of summarized postmarketing safety information, in the absence of identification of new safety “signals”, will serve to confirm the known safety profile of the product. This is important because a product’s safety profile continues to evolve long after approval. The effect is even more powerful if exposure information is made available as well, although not required.
Product X is approved after being studied in 1000 subjects in clinical trials. One year post approval 180,000 patients have been exposed in real world use and the safety profile remains the same. Despite flaws in the system for postmarketing safety information handling, prescribers are likely to feel more informed and more confident in the safety profile after addition of postmarketing safety knowledge from 180,000 patient exposures. This is true even if the additional data analysis failed to reveal any new safety insights.