[Federal Register Volume 68, Number 108 (Thursday, June 5, 2003)]
[Notices]
[Pages 33724-33727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14212]


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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://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 [email protected]. 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 
[email protected]. Electronic registration for this meeting is 
available at: 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

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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://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://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://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 
[email protected] or at 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://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

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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://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://www.fda.gov/cder/reports/prescriptioninfo/default.htm, the Action Plan at http://www.keystone.org, and a transcript of FDA's July 17, 2002, Drug Safety 
and Risk Management Advisory Committee meeting at 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