Press Release

PDMA Sampling Compliance a Growing Issue for Pharma Marketers

East Norriton, Penn., Sept. 29, 2010 — Drug sampling, a cornerstone of pharmaceutical marketing and physician relationships, is under pressure from all sides. New commercial sales models, limitations on direct physician contact and an increasingly rigorous compliance environment are changing the sampling landscape dramatically. TGaS^® Advisors, a leading benchmarking and advisory services firm, conducted a “mini-benchmark” of pharmaceutical company executives to learn how companies are adjusting to these changes and to identify areas that call for a stronger focus.

The firm found that companies are paying closer attention to the sampling provisions of the Prescription Drug Marketing Act (PDMA) because of upcoming federal and state reporting legislation mandating greater disclosure and increasing oversight of such areas as storage and transportation of samples. TGaS Advisors reported benchmark results and shared best practices and advisory insights in a just-published White Paper, “Drug Sampling: Key Issues and Best Practices.”

The White Paper analyzes industry practices in four areas – industry response, sample oversight, sales force restructuring and training — advising companies on ways to meet regulatory requirements while satisfying marketing objectives.

Kevin Sharp, Director and Management Advisor, Commercial Compliance Solutions at TGaS Advisors, and author of the White Paper said, for example, that many companies have begun to challenge the long-held belief that samples should be hand-delivered by sales representatives. “Despite fears that alternative forms of sampling, such as Direct to Practitioner (DTP) models, will negatively impact access to the provider, e-sampling and other new technologies are disproving that argument,” said Sharp.

Monitoring and tracking samples to ensure proper drug distribution and prevent diversion, particularly with the growing use of Contract Sales Organizations (CSOs), is another key section in the White Paper. Tracking also extends to proper storage and transportation of samples. Underscoring the importance of oversight, 82% of those responding to the TGaS Advisors benchmark reported using a CSO to handle at least some of their selling. “With the new focus on compliance, it is more important than ever to have monitoring systems in place that make compliance virtually automatic,” said Sharp.

The bottom line, said Sharp, is the imperative to “think strategically about how best to accomplish the goals of sampling within the increasingly rigorous compliance environment.”

About TGaS Advisors

Ranked in the top 100 among U.S. Business Products & Services companies by the Inc. 500, TGaS Advisors is the leading benchmarking and advisory services firm serving pharmaceutical commercial operations organizations. The TGaS Advisors roster includes the top 10 and the majority of the top 50 pharmaceutical companies with operations in the U.S. market. The firm provides the only comprehensive series of benchmarking solutions and advisory services for objectively improving the strategy and effectiveness of pharmaceutical operations organizations. TGaS Advisors is based in East Norriton, Pennsylvania.

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