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HHS/FDA RIN: 0910-AA37 Publication ID: Spring 1996 
Title: Prescription Drug Product Labeling; Medication Guide 
Abstract: Inadequate access to appropriate patient information is a major cause of inappropriate use of prescription medications, resulting in serious personal injury and related costs to the health care system. The Food and Drug Administration (FDA) believes that it is essential that patients receive information accompanying dispensed prescription drugs. This information needs to be widely distributed and be of sufficient quality to promote the proper use of prescription drugs. Therefore, FDA is proposing performance standards that would define acceptable levels of information distribution and quality, and to assess supplied information according to these standards. In accordance with the Administration's philosophy of fairly assessing a voluntary approach before imposing requirements through regulations, FDA is proposing that this information be disseminated through voluntary private-sector initiatives. Preliminary evidence suggests recent increases in the distribution of privately produced patient medication information with dispensed prescriptions; however, estimated distribution rates indicate that significant numbers of patients still do not receive information with their medications. FDA analyses also indicate that there is a high variability in the quality of this information. FDA believes that, with greater encouragement and clear objectives, the private sector will substantially improve the quality and distribution of patient information. Therefore, in concert with Healthy People 2000, FDA is proposing that private-sector initiatives meet the goal of distributing useful patient information to 75 percent of individuals receiving new prescriptions by the year 2000 and 95 percent of individuals receiving new prescriptions by the year 2006. FDA is proposing two alternative approaches to help ensure that these goals (performance standards) are achieved. FDA would periodically evaluate and report on achievement of these goals. If the goals are not met in the specified timeframes, FDA would either (a) implement a mandatory comprehensive Medication Guide program, or (b) seek public comment on whether the comprehensive program should be implemented or whether, and what, other steps should be taken to meet patient information goals. ^PRegardless of the approach chosen, a mandatory Medication Guide program would initially be limited to instances where a product poses a serious and significant public health concern requiring immediate distribution of FDA-approved patient information. FDA believes that substantial health care cost savings can be realized by ensuring that consumers obtain the inherent benefits of proper use of prescription drugs, and by reducing the potential for harm caused by inappropriate drug use by the patient. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
CFR Citation: 21 CFR 201    21 CFR 208    21 CFR 314    21 CFR 600   
Legal Authority: 21 USC 321    21 USC 352    21 USC 371    21 USC 355    42 USC 262   
Timetable:
Action Date FR Cite
NPRM  08/24/1995  60 FR 44182   
Final Action  06/00/1996    
Additional Information: Previously reported under RIN 0905-AE43.
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, State 
Small Entities Affected: Businesses 
Included in the Regulatory Plan: Yes 
Agency Contact:
Louis A. Morris
Chief, Marketing Practices & Communication Branch
Department of Health and Human Services
Food and Drug Administration
HFD-240, Center for Drug Evaluation and Research, 5600 Fishers Lane,
Rockville, MD 20857
Phone:301 594-6828