Commentary: Outsourcing of Regulatory Activities: How A Policy Can Drive Good Decisions
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Dmg Informution J o u m l . Vol. 34, pp. 987-989, Zoo0 Printed in the USA. All rights reserved.
COMMENTARY: OUTSOURCING OF REGULATORY ACTIVITIES: HOW A POLICY CAN DRIVE GOOD DECISIONS LORENMILLER,PHD Vice President, Regulatory and Scientific Affairs, PPD, Morrisville, North Carolina
THE PAPER BY Bates et al. titled “Outsourc- ogy and expertise. This allows for the creing regulatory activities: how a policy can ation of innovative strategies to speed drug drive good decisions” (1) presents an over- development (2,3). For example, under this view of key issues bearing on the outsourcing framework regulatory activities might be outof regulatory activities from the perspective sourced with the idea that an external vendor of a large pharmaceutical company. My com- has the capabilities to develop a regulatory mentary addresses a few issues regarding strategy for product development which outsourcing strategy, potential problems with could involve a global submission strategy outsourcing of regulatory activities, and what that includes key meetings with worldwide activities might be outsourced. The intent of regulatory authorities. However, large pharthis commentary is to provide additional in- maceutical firms have infrastructures that acformation on this timely and important topic. commodate large regulatory departments. The strategy for outsourcing here may be more piecemeal in nature with many key OUTSOURCING STRATEGY FOR regulatory activities such as liaison with REGULATORY ACTIVITIES regulatory authorities being kept in house. The outsourcing of any activity should be However, larger regulatory departments may contemplated within the context of a corpo- decide to outsource activities that are considrate philosophy on outsourcing. As the au- ered “low risk,” such as preparation of Anthors point out, outsourcing is often done on nual Reports or preparation of an efficacy the basis of constraints on staffing, that is, supplement. there are too few resources chasing too many projects. This type of outsourcing may be PROBLEMS ASSOCIATED described as tactical. However, a strategy for WITH OUTSOURCING OF outsourcing may differ for small to intermeREGULATORY ACTIVITIES diate size pharmaceutical firms compared to large pharmaceutical firms. Smaller firms The authors imply that a major issue in may outsource on a more strategic basis outsourcing regulatory activities involves adrather than a tactical basis. With strategic equately monitoring quality and whether outsourcing, the goal is to create a competi- vendors may artificially prolong work for tive advantage by adopting external technol- financial gain. These concerns probably apply to outsourcing activity in any industry. In addition, I doubt that most contract research organizations (CROs) are going to try Reprint address: Loren Miller, PhD, Vice President, to artificially prolong work in order to inRegulatory and Scientific Affairs, PPD, 3900 Paracrease financial gain. For one thing, regulamount Parkway, Monisville, NC 27560. E-mail: Loren. tory activities are usual
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