April 1, 2010

Growing public concern about adverse consequences of FDA-approved drugs and devices has led to new regulatory focus on safety monitoring. Going forward, the FDA has made clear its intent to require more rigorous efforts in this realm. In their just-published article Using Compliance Data for Strategic Advantage, (appearing in this month’s issue of Applied Clinical Trials), authors Rita E. Numerof, Ph.D., President, Jill E. Sackman, D.V.M., Ph.D., Senior Consultant, and Stephen Rothenberg, J.D., Business Analyst describe how to turn this hurdle into a strategic opportunity.

Issues raised about a product by physicians and consumers are obviously critical to public health and compliance. The authors suggest, however, that most companies overlook the potential to use such data to enhance performance and mitigate risks of related and new products across their entire lifecycles. They discuss how safety data can be used proactively to contribute more broadly to the economic and clinical value of whole product lines, with the potential for creating significant competitive advantage.