Regulatory authorities have adopted more stringent safety regulations pertaining to marketed products. The medical literature is a key source of safety information about these products, as new types of adverse reactions may first come to light as published individual case reports or a part of published clinical studies.
The FDA requires that reports of serious, unexpected adverse events (AEs) be submitted for products that have the same active moiety as that of the Marketing Authorization Holder (MAH). The FDA states that “[t]his is true even if the excipient, dosage forms, strengths, routes of administration and indications vary”. For example, even though a company markets only an oral ibuprofen formulation, they must submit reports for events involving intravenous ibuprofen.
Cost and manpower pose challenges. Subscription access to databases runs tens of thousands annually and literature articles most typically cost between $20-100. Factor in the cost of translations for certain articles (up to $600), one can see that literature review can be an expensive proposition before the first case is even processed. There is often a wealth of data in literature articles, with extensive laboratory values and detailed information on the clinical course of events. As a result, processing literature cases is very time consuming and a MAH must have sufficient manpower to properly database these cases.
Read the full whitepaper here: The Importance of Literature Searches in a Regulatory Environment