The National Council on Patient Information and Education.

These comments do not necessarily reflect those of individual members of the National Council on Patient Information and Education (NCPIE). While NCPIE commends FDA for attempting to define for publishers, pharmacies and other stakeholders what, in the agency's view, is " useful " CMI, NCPIE has significant concerns with regard to the Draft Guidance and the potential impact of FDA's recommendations on the subsequent operationalization / implementation of current efforts to achieve the goals of the Action Plan for the Provision of Useful Consumer Medicine Information (Action Plan) based on such Agency recommendations. Since January 2003, in response to a request from the FDA, NCPIE has brought together a broad base of nearly two dozen key private sector stakeholder organizations to work collaboratively to better ensure that the final goals of the Action Plan (per P.L. 104-180) are achieved. NCPIE, as one of the original members of the committee appointed by HHS Secretary Shalala in 1996 to develop the Action Plan, is pleased that the FDA has provided its draft guidance on Useful Written Consumer Medicine Information. Nevertheless, it must be pointed out that the guidance is provided so late in the 10-year timeframe delineated in the Action Plan, and that the Agency's views on what constitutes " useful " CMI are so broad as to be problematic for both stakeholders working to operationalize the Action Plan goals and consumers who would receive such CMI.