[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