Daily Rules, Proposed Rules, and Notices of the Federal Government
CMI is information developed by the private sector and distributed with each prescription at the pharmacy, as provided by law. On August 6, 1996, Public Law 104-180 was enacted and adopted the following goals with regard to CMI: 75 percent of people receiving new prescriptions would receive "useful" written patient information with their prescriptions by 2000, and 95 percent of people receiving new prescriptions would receive "useful" written patient information with their prescriptions by 2006. The committee will review and discuss a recently completed survey designed to assess whether the year 2006 goal was achieved (for results, see committee background, to be posted as described in this document). The committee will also discuss possible next steps for assuring that consumers receive useful written information with their prescriptions.
The survey is a followup to the year 2001 evaluation of the quality of consumer medication information dispensed in community pharmacies (
In 1998, FDA published a final rule that required the development of a Medication Guide for a small number of drugs that the agency considered posed a serious and significant health concern (63 FR 66378, December 1, 1998). A Medication Guide is produced by the drug sponsor, reviewed and approved by FDA and is a component of the approved professional product labeling. An FDA public meeting was held in June 2007 to obtain feedback on the development, distribution, comprehensibility and accessibility of Medication Guides. At that meeting, stakeholders voiced a concern that for prescription drugs with both a Medication Guide and CMI, patients would be getting unnecessarily duplicative information (meeting summary:
Finally, PPIs are also required for some drugs and are considered part of the approved product labeling, for example, for estrogens and oral contraceptives.
FDA will seek the advice of the advisory committee, and commentary from stakeholders and from the public, for consideration as it considers appropriate next steps to improve the communication of information about prescription drugs to patients.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is or will be available at
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FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Lee L. Zwanziger at least 7 days in advance of the meeting.
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Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).