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Recorded presentation

Pauline Vaillancourt Rosenau, PhD, Management, Policy and Community Health, University of Texas School of Public Health, 1200 Herman Pressler ST, E 915, Houston, TX 77030, 7135009491, pauline.rosenau@uth.tmc.edu, Lincy S. Lal, PharmD, PhD, College of Pharmacy and Health Sciences, Texas Southern University, 3100 Cleburne, Houston, TX 77004, and Jay H. Glasser, MS, Phd, School of Public Health, The University of Texas, PO Box 20186, Houston, TX 77025.

This paper assesses pharmacy policy, employing public health criteria. Historically US pharmacy policy has developed in parallel with medicine, emphasizing the point of view of the individual. A public health perspective on pharmacy policy, including control cost and improved performance, suggests unavoidable dilemmas. A public health perspective would lead to some surprising policy innovations in the future. As tax payer responsibility for providing medication expands, via the Medicare Prescription Drug Act and tax subsidized Health Savings Accounts, pressure for policy innovations are less likely to stress individual liberty and more likely to emphasize public health accountability because of potential cost savings. While generally considered a success by government and industry, the FDA's policy initiatives to reduce drug approval time receive a more mixed appraisal when public health performance criteria are employed. Post-marketing surveillance policies, similarly, are judged mediocre from a public health point-of-view because they depend heavily on manufacturers' fear of litigation. Post-approval monitoring would necessarily focus more on legislation to constitute a public health success. The implication of moving from informal mechanisms of enforcement grounded in the legal system, to a more active regulatory role is in agreement with a public health perspective. For the same reason, in the future the U.S. may recognize a global market in pharmaceuticals and reduce restrictions on medication importation if policy is formulated on the basis of a public health perspective. It is likely to encourage, or even require, large purchasers in public programs -- such as the Medicare Prescription Drug program – to actively negotiate for volume discounts. Direct-to-consumer advertising will come under closer scrutiny as policy makers are required to respond to a closer alignment of public health perspectives and employer/payers interests.

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