[Federal Register: June 5, 2003 (Volume 68, Number 108)]
[Notices]
[Page 33724-33727]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05jn03-88]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03N-0168]
Current Status of Useful Written Prescription Drug Information
for Consumers: 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 current status of the private sector's efforts
to provide useful written prescription drug information to consumers.
Public Law 104-180 adopted a goal that useful written information would
be distributed to 75 percent of individuals receiving new prescriptions
by the year 2000. An FDA-commissioned study of
[[Page 33725]]
written information disseminated during 2001 with four widely-used
prescription drugs reported the average ``usefulness'' of the
information was only about 50 percent. The statute's goal for 2006 is
that 95 percent of individuals receiving new prescriptions would
receive useful written information. FDA is soliciting comments on and
convening a public meeting to discuss what steps can be taken to
improve the usefulness of such written prescription drug information in
order to meet the year 2006 goal. FDA is posing four specific
questions, and the agency is interested in responses to these questions
and any other pertinent information stakeholders would like to share.
Date and Time: The public meeting will be held on July 31, 2003,
from 9 a.m. to 5 p.m. Registration to speak at the meeting must be
received by June 30, 2003. Written or electronic comments will be
accepted to the docket until September 2, 2003.
Location: The public meeting will be held at the National
Transportation Safety Board Boardroom and Conference Center, 429
L'Enfant Plaza, SW., Washington, DC 20594. (Phone: 202-314-6421; Metro:
L'Enfant Plaza station on the green, yellow, blue, and orange lines).
See: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.ntsb.gov/events/newlocation.htm. (FDA has verified the
Web site address, but FDA is not responsible for any subsequent changes
to the Web site after this document publishes in the Federal Register.)
For Information Regarding This Notice Contact: Christine Bechtel,
Center for Drug Evaluation and Research (HFD-006), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5458,
email bechtelc@cder.fda.gov. If you need special accommodations due to
a disability, please inform the contact person.
Registration and Requests for Oral Presentation: No registration is
required if you only plan to attend the meeting. Seating will be on a
first-come, first-served basis. If you wish to make an oral
presentation during the open public comment period of the meeting, you
must register to speak at the meeting by submitting your name, title,
business affiliation, address, telephone number, fax number, and e-mail
address and you must specify on your registration that you wish to make
a presentation. You must also submit the following: (1) A written
statement for each question addressed, (2) the names and addresses of
all who plan to participate, and (3) the approximate time requested to
make your presentation. Individuals who register to make an oral
presentation will be notified of the scheduled time for their
presentation prior to the meeting. Depending on the number of
presentations, FDA may have to limit the time allotted for each
presentation. All participants are encouraged to attend the entire day.
Presenters must submit two hard copies of each presentation given.
For Registration Information Contact: Christine Bechtel, Center for
Drug Evaluation and Research (HFD-006), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-594-5458, email
bechtelc@cder.fda.gov. Electronic registration for this meeting is
available at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm
, or, registration requests and materials can
be sent to Christine Bechtel.
SUPPLEMENTARY INFORMATION:
I. Background
Access to useful written patient information is an important aspect
of helping to ensure appropriate use of prescription medicines, thereby
preventing serious personal injury and avoiding excess costs to
consumers and the health care system. FDA telephone surveys have shown
that the rate of distribution of written prescription drug information
has increased over the past 20 years.
Historically, written patient information has either been required
by regulation for particular prescription drug products or product
classes, or has been distributed on a voluntary basis by the
manufacturer. Since 1968, FDA has occasionally required that
prescription drug labeling written specifically for patients in
nontechnical language be distributed to patients whenever certain
prescription drugs, or classes of prescription drugs, are dispensed. In
the 1970s, FDA began evaluating the usefulness of patient labeling for
prescription drug products generally, and published a proposed rule to
require written patient information for prescription drugs in 1979 (44
FR 40016, July 6, 1979). In 1980, FDA published a final rule
establishing requirements and procedures for the preparation and
distribution of FDA-approved patient labeling for a large number of
prescription drugs (45 FR 60754, September 12, 1980). FDA revoked those
regulations in 1982 based, in part, on assurances by the private sector
that the goals of the final rule would be met (47 FR 39147, September
7, 1982). A decision was made to allow voluntary private sector
initiatives to proceed before a determination was made whether to
impose a mandatory program.
In 1995, FDA published a proposed rule entitled ``Prescription Drug
Product Labeling; Medication Guide Requirements'' that would have
required manufacturers to prepare and distribute ``Medication Guides''
to accompany a limited number of prescription drug products that posed
a serious or significant public health concern, and set forth the
requirements for the Medication Guide program (the 1995 proposed rule)
(60 FR 44182, August 24, 1995). FDA's proposed goal for prescription
drugs that did not require Medication Guides was that, by the year
2000, at least 75 percent of people receiving new prescriptions would
receive useful written patient information, and that by 2006, 95
percent of people who receive new prescriptions would also receive
useful written patient information. The 1995 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. FDA defined ``useful'' as written in nontechnical
language and containing a summary of the most important information
about the drug. FDA also specified that the usefulness of written
patient information would be evaluated according to its scientific
accuracy, consistency with a standard format, nonpromotional tone and
content, specificity, comprehensiveness, understandable language, and
legibility.
On August 6, 1996, as FDA was reviewing the public comments on the
1995 proposed rule, Public Law 104-180 that adopted goals consistent
with the 1995 proposed rule for the distribution of useful written
patient information by the private sector, was enacted. The legislation
also required that, no later than 30 days after its enactment, the
Secretary of the Department of Health and Human Services (DHHS) (the
Secretary) would request that national organizations representing
health care professionals, consumer organizations, voluntary health
agencies, the pharmaceutical industry, drug wholesalers, patient drug
information database companies, and other relevant parties collaborate
to develop a long-range comprehensive action plan (Action Plan) to
achieve goals consistent with the goals of the 1995 proposed rule.
Required elements of the Action Plan included: an assessment of the
effectiveness of the current private-sector approaches to providing
consumer medication information; the development of guidelines for
providing effective
[[Page 33726]]
consumer medication information consistent with the findings of such
assessment; the identification of components necessary to ensure the
transmittal of useful information to the public expected to use the
product, including the criteria identified in the 1995 proposed rule;
and the development of a mechanism to periodically assess the quality
of prescription information and the frequency with which it is provided
to consumers.
Under subsection (d) of section 601 of Public Law 104-180, FDA
could not implement the portion of the proposed rule, or any other
regulation or guideline, that specified a uniform, FDA-approved content
or format for written information voluntarily provided to consumers
about prescription drugs, if private sector organizations met the
requirements of the long-range Action Plan within the timeframe
provided by the law.
The law also required DHHS to review the status of the private
sector initiatives designed to achieve the goals of the action plan by
January 1, 2001. Public Law 104-180 required that if 75 percent of
individuals receiving new prescriptions did not receive useful written
information by the year 2000, the limitation in subsection (d) of
section 601 would not apply and the Secretary was required to seek
public comment on other initiatives that could meet the goals.
Initially following the enactment of Public Law 104-180, the
Secretary asked the Keystone Center to convene a Steering Committee to
collaboratively develop the Action Plan. The Action Plan accepted by
the Secretary in January 1997 reiterated the target goals specified in
Public Law 104-180. The Action Plan endorsed the criteria specified in
Public Law 104-180 for defining the usefulness of medication
information. Specifically, the Action Plan stated that such materials
should be: (1) Scientifically accurate; (2) unbiased in content and
tone; (3) sufficiently specific and comprehensive; (4) presented in an
understandable and legible format that is readily comprehensible to
consumers; (5) timely and up to date; and (6) 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.keystone.org.
(FDA has verified the Web site address, but FDA is
not responsible for any subsequent changes to the Web site after the
document publishes in the Federal Register.)
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 provided to patients. To test a
methodology for collecting patient information materials and assessing
their usefulness, FDA contracted with the National Association of
Boards of Pharmacy (NABP). The contract called for the selection of
several State Boards of Pharmacy, which would arrange for collecting,
from a sample of State pharmacies, written materials given to patients
when new prescriptions for three commonly prescribed drugs were filled.
The contract also called for the development of an expert panel to
create evaluation materials to assess the usefulness of the information
through application of the Action Plan criteria. The written
prescription drug information was collected in 1999, and the final
report from the pilot study was completed in December 1999 and
presented by FDA at a public workshop on February 29-March 1, 2000.
In 2001, FDA commissioned NABP to subcontract a national study to
assess the usefulness of written prescription drug information being
distributed to patients. A professional shopper firm was hired to bring
prescriptions for four widely prescribed drugs in different drug
classes to 384 pharmacies selected in a statistically random fashion
from a national list. All written materials received with the
prescriptions were sent to an expert panel for evaluation against the
criteria endorsed by the Action Plan. The results of the study were
announced in 2002. The evaluation found that, on average, 89 percent of
patients received some form of written medication information. However,
the expert panel found that the average ``usefulness'' of the
information was only about 50 percent. The report of the evaluation is
available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/reports/prescriptioninfo/default.htm
.
The report findings were presented at an FDA Drug Safety and Risk
Management Advisory Committee (the Advisory Committee) meeting on July
17, 2002. The Advisory Committee recommended that FDA take a more
active role in advising and encouraging the private sector to meet the
2006 goal. FDA accords the recommendations of all advisory committees
significant weight, but such recommendations are not binding on the
agency. A transcript of FDA's Drug Safety and Risk Management Advisory
Committee meeting on July 17, 2002, is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3874T1.htm
.
II. Scope of Discussion
In view of the facts described in section I of this document, FDA
is soliciting comments on several issues and is convening this public
meeting on July 31, 2003, to discuss the current status of the private
sector's efforts to provide useful written prescription drug
information to consumers. Interested persons are invited to submit
comments to the docket and to attend the public meeting and present
their views. Issues that we are asking interested parties to address in
their comments, at the public meeting, or both, are as follows:
1. What steps is the private sector taking to improve the
usefulness of the written information patients receive with
prescription drugs and to meet the Year 2006 goal?
2. What barriers exist for the private sector to meet the Year 2006
goal, and what plans exist to overcome these barriers?
3. What should the role of FDA be in assuring full implementation
of the Action Plan to meet the Year 2006 goal?
4. What other initiatives should FDA consider for providing
patients with useful written information about prescription drugs as
endorsed by Public Law 104-180? Such initiatives could include the
possibility of FDA requiring manufacturers to provide authorized
dispensers with the means to distribute useful written information
approved by FDA.
III. Comments
Interested persons may submit to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, written or electronic comments on or before
September 2, 2003. You must submit two copies of comments, identified
with the docket number found in brackets in the heading of this
document. Submit electronic comments by September 2, 2003, to
fdadockets@oc.fda.gov or at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
You should annotate and organize your comments
to identify the specific questions to which they refer. Comments to the
docket can be reviewed in the Dockets Management Branch, Monday through
Friday between 9 a.m. and 4 p.m. or on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/dockets/dockets.htm
(select docket [numsign]
03N-0168).
IV. Transcripts
You may request a copy of the transcript in writing from the
Freedom of Information Office (HFI-35), Food
[[Page 33727]]
and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD
20857, approximately 15 days after the meeting at a cost of 10 cents
per page. You may also examine the transcript Monday through Friday
between 9 a.m. and 4 p.m. in the Dockets Management Branch or on the
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/dockets/dockets.htm
(select docket [numsign] 03N-0168). The transcript will be available 4-
6 weeks after the meeting.
V. Electronic Access
Persons with access to the Internet may obtain a copy of the
commissioned study report at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/reports/prescriptioninfo/default.htm
, the Action Plan at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.keystone.org, and a transcript of FDA's July 17, 2002, Drug Safety
and Risk Management Advisory Committee meeting at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3874T1.htm
.
Dated: May 22, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-14212 Filed 6-4-03; 8:45 am]
BILLING CODE 4160-01-S