[Federal Register Volume 65, Number 29 (Friday, February 11, 2000)]
[Notices]
[Pages 7022-7023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3171]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-0352]


Status of Useful Written Prescription Drug Information for 
Patients; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to discuss the findings of the interim study of the status of 
useful written prescription drug information for patients consistent 
with the criteria specified in the ``Action Plan for the Provision of 
Useful Prescription Medicine Information'' (Action Plan). The purpose 
of this meeting is to present the study methodology and results and 
seek feedback prior to developing assessment of the year 2000 goals. 
The meeting will begin with presentations about the report and 
findings, followed by small group discussions and feedback. FDA 
encourages interested individuals to attend this meeting or submit 
comments.

DATES: The public meeting will be held on Tuesday, February 29, 2000, 
from 1 p.m. to 5:30 p.m. and Wednesday, March 1, 2000, from 8:30 a.m. 
to 3 p.m. The deadline for registration is February 18, 2000. Early 
registration is recommended, as space is limited. Registration and 
dissemination of materials will begin at 11 a.m. on February 29, 2000. 
Written comments will be accepted until April 28, 2000.

ADDRESSES: The public meeting will be held at the DoubleTree Hotel, 
1750 Rockville Pike, Rockville MD 20852. Submit written comments to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville MD 20852. Two copies of any comments 
are to be submitted, except that individuals may submit one copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. A copy of the study report as well as 
registration information can be obtained at http://

[[Page 7023]]

www.fda.gov/cder/calendar/meeting/rx2000. A transcript and summary of 
the meeting may be seen at the Dockets Management Branch (address 
above).

FOR FURTHER INFORMATION CONTACT: Marcia L. Trenter, Center for Drug 
Evaluation and Research (HFD-210), Food and Drug Administration, 5600 
Fisher Lane, Rockville, MD 20857, 301-827-1674, or e-mail: 
[email protected]).

SUPPLEMENTARY INFORMATION: Inadequate access to useful patient 
information is a major cause of inappropriate use of prescription 
medicines, leading to serious personal injury and costs to the health 
care system. While the rate of distribution of written prescription 
drug information materials has increased somewhat over the past 15 
years, the quality of such material has been quite variable.
    In the Federal Register of August 24, 1995 (60 FR 44182), FDA 
published a proposed rule that aimed to increase the quality and 
quantity of written information about prescription medicines given to 
patients. In the proposed rule, entitled ``Prescription Drug Product 
Labeling; Medication Guide Requirements,'' FDA encouraged the private 
sector to develop and distribute patient-oriented written information 
leaflets for all prescription drugs, and set targets for the 
distribution of these leaflets. In addition to setting target 
distribution goals by specific dates, the proposed rule set criteria by 
which written information would be judged to determine whether it was 
``useful'' and should therefore count toward accomplishment of the 
target goals.
    In August 1996, the U.S. Congress passed Public Law 104-180 
mandating that the private sector be given the opportunity to meet 
distribution and quality goals for written patient prescription 
medicine information. It also directed that the Secretary of Health and 
Human Services (the Secretary) facilitate the development of a long-
range comprehensive action plan to meet these goals through private-
sector efforts.
    The Secretary asked the Keystone Center to convene a Steering 
Committee to collaboratively develop this action plan. The Action Plan 
accepted by the Secretary in January 1997 reiterated the target goals 
specified in the Federal legislation. These goals were that by the year 
2000 useful written information would be distributed to 75 percent of 
individuals receiving new prescriptions for medicines, and by the year 
2006 to 95 percent of such individuals. The Action Plan generally 
endorsed the conceptual criteria specified in Public Law 104-180 for 
defining the usefulness of medication information. Specifically, it 
stated that such materials should be: (1) Scientifically accurate; (2) 
unbiased in content and tone; (3) sufficiently specific and 
comprehensive; (3) presented in an understandable and legible format 
that is readily comprehensible to consumers; (4) timely and up to date; 
and (5) useful, that is, enables the consumer to use the medicine 
properly and appropriately, receive the maximum benefit, and avoid 
harm. The Action Plan, including descriptions of the criteria, is 
available on the Internet at http://www.nyam.org/library/keystone.
    Consistent with Public Law 104-180, the Action Plan called for the 
development of a mechanism to periodically assess the quality of 
written prescription information for patients. To test a methodology 
for collecting patient information materials and assessing their 
usefulness, FDA developed a contract with the National Association of 
Boards of Pharmacy. The contract called for the selection of several 
State Boards of Pharmacy who would arrange for collecting, from a 
sample of State pharmacies, medication information materials given with 
new prescriptions for three commonly prescribed prescription drugs. The 
contract also called for the development of evaluation materials to 
assess the usefulness of the information through application of the 
Action Plan criteria. The medication information materials were 
collected in 1999, and the final report from the evaluation was 
completed in December 1999. The report is available on the Internet at 
http://www.fda.gov/cder/calendar/meeting/rx2000.
    FDA is seeking comments on several issues:
     What should be the minimum standard or threshold that must 
be met for written information to be considered useful?
     Should certain criteria derived from the Action Plan 
recommendations be given more weight than others? If so, which criteria 
should be weighted more strongly, and why?
     Are the evaluation forms an accurate translation of the 
Action Plan's criteria?
     Should the assessment include additional criteria or types 
of information, and, if so, what?
     Should there be a more detailed assessment of factors 
affecting readability and legibility for consumers (e.g., type size, 
style, spacing, contrast)?
     Should the evaluation panel include consumers with varying 
educational backgrounds? If so, how should they be involved in the 
evaluation process?
     This report collected patient information from U.S. retail 
pharmacies. Are there ways to expand sampling to include mail-order or 
other nonretail pharmacies?
    A transcript and summary of the meeting may be seen at the Dockets 
Management Branch (address above) and they will be available 
approximately 10 working days after the meeting at a cost of 10 cents 
per page. Also, received comments may be seen in that office between 9 
a.m. and 4 p.m., Monday through Friday.

    Dated: February 4, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-3171 Filed 2-10-00; 8:45 am]
BILLING CODE 4160-01-F