FDA Actions Against Misleading Health Economic Promotions, 2002-2011

Boston, MA, USA – The study, “FDA Actions Against Health Economic Promotions, 2002-2011,” published in Value in Health, the official journal of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR), investigated FDA regulatory actions against drug companies’ health economic promotions from 2002 through 2011 in order to understand how frequently and in what circumstances the Agency has considered such promotions false or misleading.

The Center for the Evaluation of Value and Risk in Health at Tufts Medical Center’s Institute for Clinical Research and Health Policy Studies, located in Boston, MA, conducted this study with the aim of understanding the frequency and nature of FDA regulatory actions against inappropriate health economic promotions since 2001.

Of 291 warning letters and notices of violation issued by the FDA’s Division of Drug Marketing Advertising and Communications (DDMAC) to pharmaceutical companies from 2002-2011, 35 cited a health economic violation. The most common type of violation cited was an implied claim of cost-savings due to work productivity or functioning (found in 20 letters), followed by unsubstantiated comparative claims of effectiveness, safety, or interchangeability (7 letters).

All letters that DDMAC issued to pharmaceutical companies were reviewed and analyzed those containing a violation related to “health economic promotion,” defined according to one of several categories (e.g., implied claims of cost-savings due to work productivity; economic claims containing unsupported statements about effectiveness or safety). We also collected information on factors, such as the indication and type of media involved, and whether the letter referenced Section 114 of the Food and Drug Administration Modernization Act (FDAMA).

“This study emphasizes the need for caution when it comes to data interpretation. Given the relatively low frequency of economic violation letters, either the FDA is choosing to ignore most health economics claims or the pharmaceutical industry is choosing to avoid making such claims,” said Peter J. Neumann, ScD, Director, Center for the Evaluation of Value and Risk in Health, Tufts Medical Center and Professor of Medicine, Tufts University School of Medicine.

Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research as well as policy papers to help health care leaders make evidence-based decisions. The journal is published bi-monthly and has over 8,000 subscribers (clinicians, decision makers, and researchers worldwide).

International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a nonprofit, international, educational and scientific organization that strives to increase the efficiency, effectiveness, and fairness of health care resource use to improve health.

For more information: www.ispor.org

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