[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Proposed Rules]
[Pages 2971-2973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1740]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 208, 314, and 601

[Docket No. 93N-371W]


Prescription Drug Product Labeling; Public Patient Education 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of a public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is reannouncing a 
public patient education workshop to discuss methods and criteria for 
developing and evaluating prescription drug information for patients. 
Previously, in the Federal Register of December 8, 1995 (60 FR 63049), 
the agency announced this workshop which was scheduled for January 9 
and 10, 1996. Due to inclement weather, the agency was forced to 
postpone the workshop. The agency has rescheduled the workshop for 
February 14 and 15, 1996. The purpose of this workshop is to obtain 
views and opinions concerning the criteria for useful patient 
information, and it is part of FDA's ongoing initiative to improve the 
distribution of adequate and useful prescription drug information to 
patients. FDA encourages health professionals, consumer groups, and 
other interested parties to participate in the workshop. FDA also 
invites the designers of primary information systems, which produce 
either written information or computer programs that generate 
prescription drug patient information, to display their systems for 
educational purposes.

DATES: The public patient education workshop will be held on February 
14 and 15, 1996, from 8:30 a.m. to 5 p.m. Submit registration notices 
for participants by February 9, 1996. Submit registration notices for 
designers of information systems by February 7, 1996. Submit written 
comments by March 6, 1996.

ADDRESSES: The public patient education workshop will be held at the 
DoubleTree Hotel, 1750 Rockville Pike, Rockville, MD. Preregistration 
for workshop participants is encouraged, although not required, in 
order to facilitate logistical planning of the breakout discussion 
groups. There is no registration fee for this workshop. Registration 
forms can be obtained by calling 301-443-5470 or writing to the Office 
of Health Affairs, ATTN: Patient Education Workshop, Food and Drug 
Administration (HFY-40), 5600 Fishers

[[Page 2972]]

Lane, Rockville, MD 20857. Submit written views or comments to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. The designers of 
information systems should call the contact person (address below) for 
registration information. A more detailed agenda and written 
presentations will be placed in the docket, identified with the docket 
number found in brackets in the heading of this document, at the 
Dockets Management Branch, and will be available for review between 9 
a.m. and 4 p.m., Monday through Friday. A transcript of the general 
sessions of the workshop will be available for review or purchase (10 
cents per page) at the Dockets Management Branch approximately 5 
business days after the meeting. The breakout sessions will not be 
transcribed.

FOR FURTHER INFORMATION CONTACT: Thomas J. McGinnis, Office of Health 
Affairs (HFY-40), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-5470.

SUPPLEMENTARY INFORMATION: On January 9 and 10, 1996, FDA had intended 
to hold a public patient education workshop to discuss methods and 
criteria for developing and evaluating prescription drug information 
for patients. The agency was forced to postpone the workshop due to the 
closing of the Federal Government because of inclement weather in the 
metropolitan Washington, DC area. With this notice the agency is 
announcing the rescheduling of the workshop for February 14 and 15, 
1996. The purpose and agenda for the meeting are identical to the 
previously scheduled workshop, with a few minor changes in the agenda 
due to the scheduling problems of the original invited presenters.
    In the Federal Register of August 24, 1995 (60 FR 44182), FDA 
published a proposed rule that, if finalized, is intended to increase 
the dissemination of useful written prescription drug information to 
patients who receive drugs on an outpatient basis. In that proposal, 
the agency stated its belief that the quality of medical care could be 
enhanced and substantial costs from drug misadventures could be reduced 
by better informing patients about the use, side effects, and 
interactions of such drugs. At that time, the agency discussed a 
mandatory Federal program that would require such information to be 
distributed with most new prescriptions. However, the agency also 
stated that such a program would not be necessary if private sector 
efforts now underway accomplished the stated goal. Thus, FDA proposed, 
except where there is a serious and significant public health concern, 
to defer its program for several years.
    To judge the success of those private efforts, the agency proposed 
goals (performance standards) that would define acceptable levels of 
information distribution and quality. To meet the performance standard 
for distribution of information, the agency proposed that by the year 
2000 at least 75 percent of people receiving new prescriptions receive 
useful information. This goal was adapted from the Public Health 
Service's ``Healthy People 2000'' report. In addition, the agency 
proposed that by the year 2006, at least 95 percent of the people who 
receive new prescriptions receive useful information.
     FDA proposed to periodically evaluate and report on the 
achievement of the goals. If the goals are not met in the specified 
timeframes, FDA proposed to either: (1) Implement a mandatory 
comprehensive medication guide program, or (2) seek public comment on 
whether a comprehensive program should be implemented, or whether, and 
what, other steps should be taken to meet the patient information 
goals.
    To develop a performance standard for the quality of information 
distributed, FDA suggested seven specific components in its August 24 
proposal for determining whether patient information is useful: 
Scientific accuracy, consistency with a standard format, nonpromotional 
tone and content, specificity, comprehensiveness, understandable 
language, and legibility. The agency defined these components of 
usefulness, as well as criteria that could be used to judge these 
components, and invited comments on their appropriateness. Because such 
criteria are of great interest to affected parties, and because there 
is substantial expertise in the development and communication of 
patient information, FDA also stated its intention to hold a public 
meeting that would allow the many interested groups and individuals to 
provide their recommendations directly to agency officials.
    The agency will hold a public patient education workshop to discuss 
the methods and criteria for developing and evaluating the usefulness 
of written information. The patient education workshop will be designed 
to obtain recommendations from the public about the criteria that 
should be applied to help ensure that written information provided to 
patients is ``useful.''
    The patient education workshop will be comprised of both formal 
presentations and open breakout discussion periods. Any interested 
person may attend and participate in the discussions. The workshop will 
include general sessions with presentations from FDA, health 
professional groups, consumer groups, the pharmaceutical industry, 
academicians, and parties with legal and regulatory expertise. The 
agency also intends to hold breakout sessions the morning of the second 
day to obtain broad participation and input from workshop attendees.
     On Wednesday, February 14, 1996, there will be a series of 
presentations by consumer organizations, health professional 
organizations, researchers, and academicians. There will be time set 
aside for comments and questions from workshop participants. On 
Thursday, February 15, 1996, workshop participants will be divided into 
several breakout groups for discussions and development of 
recommendations regarding elements of useful information. These 
recommendations will then be presented to the workshop participants 
with time for comments and questions.
    FDA believes that it would be helpful for workshop participants, 
including FDA staff, to learn about the design of current patient 
information systems, particularly programs that generate drug-specific 
patient information. The agency invites the designers of primary 
information systems, not the customizers of systems for retail outlets, 
to display their systems at the workshop for educational purposes only. 
No sales or solicitations may be made by exhibitors at the workshop 
site. Due to space limitations, FDA may be forced to limit the number 
of systems on display. In doing so, FDA would seek to permit display of 
the most representative/comprehensive systems available for patient 
information. However, the agency invites all interested persons to 
submit their views, comments, and descriptions of computer programs to 
the Dockets Management Branch (address above).
    The agency notes that the comment period for the proposed rule that 
published in the Federal Register of August 24, 1995, closed on 
December 22, 1995 (60 FR 58025, November 24, 1995). Because this 
workshop will occur after the comment period has closed, the agency 
will accept additional comments to the proposed rule on the specific 
issues raised at the workshop. These comments will be considered as 
part of the agency's deliberations regarding further action on this 
rulemaking. For this limited purpose, written comments may be submitted 
to the Dockets Management Branch (address above) 

[[Page 2973]]
until March 6, 1996. Comments are to be identified with the docket 
number found in brackets in the heading of this document.
    A summary of the workshop will be included in a subsequent Federal 
Register notice related to this prescription drug labeling initiative.

    Dated: January 22, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-1740 Filed 1-29-96; 8:45 am]
BILLING CODE 4160-01-F