A large pharmaceutical company contracted Pinney Associates to support the prescription to over-the-counter switch of an established product in a new OTC category.  A broad-ranging identification and assessment of likely concerns enabled the company to anticipate and prepare thoughtful, well-supported positions and responses.  Pinney Associates identified areas where sufficient scientific data was lacking, and implemented a comprehensive program of supportive secondary data analyses and behavioral research.  This effort resulted in the approval of a competitive OTC label that was eventually supplemented with a stream of peer-reviewed publications supporting both monadic and competitive claims.