Drug Information Journal - March 2009 - (Page 124) 124 MEDICAL INFORMATION Whitehead, Lomma, Tran, Miao, Pikalov FIGURE 1 There are several common reasons for pharmaceutical alliances to fail. Of these reasons, it is important to consider the factors that can be controlled versus those factors that are not within a company’s influence. Data adapted from Ref. 9. 80 70 60 50 Percent 40 30 20 10 0 Product Failure Market Change Poor Poor Communication Negotiation Undefined Roles Poor Leadership Weak Commitment Different Cultures Sr Mgt Changes on dividing the years between the end of the product patent/alliance commitment and start of alliance into equal parts. Therefore, one third of the time was spent in the early phase, one third in a middle phase, and one third spent in the late phase of the product’s life cycle. Because a drug’s marketing life varies based on a number of factors including product development timelines and patent exclusivity, a set specific amount of time in years for each phase may not apply to all drugs equally. F O R M AT I O N O F A M E D I C A L I N F O R M AT I O N A L L I A N C E Two main responsibilities of the pharmaceutical industry were identified as early as 1962 by the Pharmaceutical Manufacturer’s Association Commission on Drug Safety. The first responsibility identified was to provide therapeutic agents of uniformly high quality. The second responsibility was to supply the medical profession with the best available information pertaining to their use, which is customarily provided by the company’s medical information team (12). These responsibilities still hold true today. The medical information department provides written and verbal medical information pertain- ing to the company’s drug product as well as the indicated disease state to health care professionals and consumers. In addition, the medical information department in some companies provides medical review of promotional and sales training materials. FDA requires that all promotional information is accurate, not misleading, provides a balance of risks and benefits, makes claims only when supported by substantial evidence, and is consistent with FDA-approved labeling (13). The responsibilities of the medical information department are outlined in Table 1. These responsibilities may vary from company to company; for example, some companies include the medical science liaison (MSL) team within the medical information department while in other companies MSLs are a team within a separate department, as in our case. In our alliance of medical information departments, the authors come from two companies that represent different sides of a business partnership. One company represents a larger, more established pharmaceutical company and is currently involved in multiple partnerships. The other company is smaller, without the largescale infrastructure to support a major product
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