title: Managing the interface with marketing to improve delivery of pharmacovigilance within the pharmaceutical industry.
abstract: The pharmaceutical industry is under pressure to improve the scientific quality of its decisions concerning the benefit and risks of its products while ensuring compliance with acceptable standards of marketing. All those in a pharmaceutical company who currently work within pharmacovigilance should be encouraged to lead from the front to examine ongoing marketing activities to see how they can be adapted more towards pharmacovigilance and risk management. The current irony is that the personnel who have the greatest influence on benefit-risk decisions of a product are not necessarily those who acknowledge that they are performing pharmacovigilance. Indeed, for all concerned, whether their orientation is scientific and commercial, effective communication with prescribers and consumers usually underpins product success. Also, a substantial 'marketing' budget is culturally acceptable for the pharmaceutical industry so it is logical to assume that resource for postmarketing activity is often made available. Given these realities, I suggest we should strive for an integrated marketing and risk-management plan based on the best available evidence and that being fully aware and in control of the safety issues for your products is the best way to commercialise them successfully. This approach can still be consistent with other corporate responsibilities such as trying to reduce the financial burden of product development. If this article stimulates further debate about how the pharmaceutical industry can more effectively organise resources and operations to support pharmacovigilance, risk management, and marketing, then it will have achieved its purpose.
authors.affiliation: PAREXEL International, Uxbridge, United Kingdom. brian.edwards@parexel.com
authors.forename: Brian
authors.initials: B
authors.lastname: Edwards
mesh_terms: D004345:Drug Industry / Q000941:ethics / Q000458:organization & administration / Q000592:standards*; D017850:Economics, Pharmaceutical; D040541:Marketing / Q000941:ethics / Q000379:methods*; D012308:Risk Management / Q000379:methods*