[Federal Register: May 26, 2005 (Volume 70, Number 101)]
[Page 30467-30469]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005D-0169]

Draft Guidance on Useful Written Consumer Medication Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Useful Written Consumer 
Medication Information (CMI).'' CMI is written information developed 
for consumers about prescription drugs that is distributed to consumers 
when they have prescriptions filled. The guidance discusses general 
issues and makes recommendations on the content of useful written CMI.

DATES: Submit written or electronic comments on the draft guidance by 
July 25, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 See the SUPPLEMENTARY INFORMATION section for electronic 

access to the draft guidance document.

Evaluation and Research (HFD-410), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7843.


I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Useful Written Consumer Medication Information (CMI).'' This draft 
guidance is intended to assist individuals or organizations (e.g., 
pharmacies, private vendors, healthcare associations) in developing 
useful written CMI. CMI is written information about prescription drugs 
developed by organizations or individuals, other than a drug's 
manufacturer, that is intended for distribution to consumers at the 
time of dispensing. Since neither FDA nor the drug's manufacturer 
reviews or approves CMI, FDA recommends that the developers of written 
medication information use the factors discussed in this guidance to 
ensure that their CMI is useful to consumers.
    Traditionally, FDA has believed that when people are well-informed 
about the medications they take, they are able to make better decisions 
about their healthcare and better use of the prescription medications 
available to them. Access to useful written information about 
prescription medications is important to ensuring appropriate use of 
these products. In 1996, a steering committee comprised of interested 
stakeholders (including healthcare professionals, consumer 
organizations, voluntary health agencies, pharmaceutical manufacturers, 
prescription drug wholesalers, drug information database companies, CMI 
developers, and

[[Page 30468]]

others), facilitated by the Keystone Center, collaboratively developed 
a report entitled ``Action Plan for the Provision of Useful 
Prescription Medicine Information'' (the Action Plan).\1\ The Action 
Plan outlined criteria for evaluating whether a particular piece of 
written medical information is useful to consumers. It represented the 
culmination of a long history of efforts aimed at ensuring that 
consumers receive useful information regarding their prescription 

    \1\ Steering Committee for the Collaborative Development of a 
Long-Range Action Plan for the Provision of Useful Prescription 
Medicine Information, unpublished report submitted to The Honorable 
Donna E. Shalala, Secretary of Health and Human Services (HHS), 
December 1996, available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/offices/ods/keystone.pdf


A. Regulatory History Preceding the Action Plan

    Since 1968, FDA regulations have required that patient package 
inserts, written specifically for patients, be distributed to patients 
when certain prescription drugs, or classes of prescription drugs, are 
dispensed (see 21 CFR 310.501 for oral contraceptives and 310.515 for 
estrogens). FDA regulations also require pharmaceutical manufacturers 
to develop and distribute written patient labeling called Medication 
Guides for prescription drug products that pose a serious and 
significant public health concern (21 CFR 208.1(c)). These Medication 
Guides are required to be written in nontechnical language (21 CFR 
208.20(a)(1)). In addition, drug manufacturers have voluntarily agreed 
with FDA to produce and distribute patient labeling for many other 
prescription drugs and classes. A description of how the FDA 
regulations evolved is provided in the following paragaraphs.
1. The First Proposed Rule That Required Written Patient Information
    In the 1970s, FDA began evaluating the general usefulness of 
patient labeling for prescription drugs and, in 1979, published a 
proposed rule to require written patient information for all 
prescription drugs (44 FR 40016, July 6, 1979). In 1980, FDA published 
a final rule establishing requirements and procedures for the 
preparation and distribution of manufacturer-prepared and FDA-approved 
patient labeling for a limited number of prescription drugs (45 FR 
60754, September 12, 1980). In 1982, FDA revoked those regulations, in 
part based on assurances by pharmaceutical manufacturers, healthcare 
professional associations, and private-sector providers of written 
medication information for patients that the goals of the final rule 
would be met more effectively and with greater innovation without 
regulation (47 FR 39147, September 7, 1982). FDA committed itself to 
monitor the progress of this private-sector effort.
2. The Medication Guide Rule
    Periodic FDA surveys showed that although the distribution of 
written prescription drug information increased, the usefulness of the 
information was highly variable. Consequently, in 1995, FDA published a 
proposed rule entitled ``Prescription Drug Product Labeling; Medication 
Guide Requirements'' (60 FR 44182, August 24, 1995). The proposal was 
designed to aid patients in receiving useful written information about 
the prescriptions they were given by setting specific distribution and 
quality goals and time frames for achieving them. The goals that FDA 
proposed in the rule were that, by the year 2000, 75 percent of people 
receiving new prescriptions would receive useful written patient 
information with their prescriptions; by 2006, 95 percent of people 
receiving new prescriptions would receive useful written patient 
information with their prescriptions. The proposed rule also described 
criteria for usefulness to permit evaluation of whether the information 
met the target goals.\2\ In addition to setting these goals, the 
proposed rule was designed to require manufacturers to prepare and 
distribute Medication Guides for a limited number of prescription drug 
products that posed a serious and significant public health concern.

    \2\ FDA also specified that the usefulness of written patient 
information would be evaluated based on its scientific accuracy, 
consistency with a standard format, nonpromotional tone and content, 
specificity, comprehensiveness, understandable language, and 

3. Medication Guide Legislation
    On August 6, 1996, as FDA was reviewing the public comments on the 
1995 proposed rule, Public Law 104-180 was enacted.\3\ It adopted goals 
and time frames consistent with the 1995 proposed rule. The legislation 
also required the Secretary of HHS (the Secretary) to request that a 
representative group of interested stakeholders collaborate to develop 
a long-range comprehensive action plan (the Action Plan) to achieve the 
goals specified in the statute. Required elements of the Action Plan 
included the following items:

    \3\ Public Law 104-180, Title VI, Sec 601 Effective Medication 
Guides, 110 Stat 1593 (1996).

     An assessment of the effectiveness of the current private-
sector approaches to providing CMI;
     Development of guidelines for providing effective CMI 
consistent with the findings of such assessment;
     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; 
     Development of a mechanism to periodically assess the 
quality of prescription information and the frequency with which that 
information is provided to consumers.
    The law prohibited FDA from taking further regulatory steps 
specifying a uniform content or format for written information 
voluntarily provided to consumers about prescription drugs if private-
sector initiatives met the goals of the plan within the specified time 
frames. However, if evaluations showed that the goals were not met, the 
limitation would not apply, and the Secretary would be required to seek 
public comment on other initiatives that could meet the goals.

B. The Development and Implementation of the Action Plan

    As mentioned previously in this document, a steering committee 
comprised of interested stakeholders, facilitated by the Keystone 
Center, collaboratively developed the Action Plan, which the Secretary 
accepted in January 1997. 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 
``[p]rescription medicine information shall be useful to consumers'' 
and provided criteria that are intended to define useful CMI. As stated 
in the Action Plan, useful written information is that which ``* * * is 
sufficiently comprehensive and communicated [in] such [a way] that 
consumers can make informed decisions about how to receive the most 
benefit from medicines and protect themselves from harm. Both the 
substance and presentation of the information are important.'' 
Specifically, the Action Plan stated that such materials should meet 
the following criteria:
     Scientifically accurate;
     Unbiased in content and tone;
     Sufficiently specific and comprehensive;
     Presented in an understandable and legible format that is 
readily comprehensible to consumers;

[[Page 30469]]

     Timely and up-to-date; and
     Useful, that is, enables the consumer to use the medicine 
properly and appropriately, receive the maximum benefit, and avoid 
The Action Plan includes descriptions of the criteria.
1. The Pilot Study That Applied the Action Plan Usefulness Criteria
    To test a methodology for assessing the usefulness of CMI in 
relation to the requirements of the law, FDA contracted with the 
National Association of Boards of Pharmacy (NABP) to conduct a pilot 
study. In 1998, NABP arranged for the collection of written materials 
given to patients who filled new prescriptions for three commonly 
prescribed drugs from a sample of State pharmacies. An expert panel 
developed assessment tools, applying the Action Plan criteria, and used 
them to evaluate the usefulness of the collected CMI materials. The 
pilot study report\4\ was presented by the director of the expert panel 
and discussed by stakeholders at an FDA public workshop from February 
29 to March 1, 2000 (65 FR 7022, February 11, 2000).

    \4\ Svarstad, B. L. and D. C. Bultman, ``Evaluation of Written 
Prescription Information Provided in Community Pharmacies: An 8-
State Study,'' interim report to HHS and FDA, December 1999, 
available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/calendar/meeting/rx2000/report1.htm


2. The National Study That Applied the Action Plan Usefulness Criteria
    In 2001, FDA commissioned NABP to conduct a national study to 
assess the extent to which the year 2000 goals specified in the law had 
been achieved. A random sample of pharmacies across the continental 
United States was selected. Patients submitted prescriptions at each 
pharmacy for four commonly prescribed drugs and collected any written 
materials given to them when the medications were dispensed. The 
materials 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.
    On average, 89 percent of the patients received some form of 
written medication information. However, the average usefulness of the 
information was only about 50 percent. The evaluation report\5\ is 
available on the Internet 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


    \5\ Svarstad, B. L. and J. K. Mount, ``Evaluation of Written 
Prescription Information Provided in Community Pharmacies, 2001,'' 
final report to HHS and FDA, December 2001.

3. The Advisory Committee Meeting That Led to the Development of This 
    The report findings were presented at an FDA Drug Safety and Risk 
Management Advisory Committee (Advisory Committee) meeting on July 17, 
2002 (67 FR 45982, July 11, 2002). In addition, public comments were 
requested about the steps the private sector was taking to meet the 
target goals of Public Law 104-180, possible barriers to meeting the 
goals and plans to overcome those barriers, the role FDA should take in 
assuring full implementation of the Action Plan, and other initiatives 
FDA should consider in facilitating achievement of the goals (68 FR 
33724, June 5, 2003). The Advisory Committee recommended that FDA take 
a more active role in advising and encouraging the private sector to 
meet the next target goal set for 2006. A transcript of FDA's Drug 
Safety and Risk Management Advisory Committee meeting on July 17, 2002, 
is available 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/ac/02/transcripts/3874t1.htm.
 Subsequent to the Advisory Committee meeting, 

FDA stated its belief that the voluntary approach to improving the 
distribution of useful CMI could still work to meet the legislatively 
mandated 2006 level if efforts to improve began immediately. FDA 
considered the Advisory Committee recommendations, the public comments, 
and the findings of strong CMI distribution rates but clear 
deficiencies in quality, and identified three specific areas in need of 
consensus and action by the relevant stakeholders to meet the 2006 
goal. The following areas were identified: (1) Implementation 
(identifying roles and responsibilities among the stakeholders and 
methods for overcoming barriers to meeting the goals); (2) evaluation 
(determining how quality improvements can be made in areas of CMI 
deficiencies); and (3) education (implementing procedures so that all 
CMI developers, pharmacists, and professional associations are aware of 
the statutory requirements).
    The agency met with various groups and held a public meeting in 
2003 (see http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/offices/ods/writtenprescripinfo.htm). 

In these meetings, the agency was asked to provide clarification on how 
the Action Plan should be interpreted and implemented. This guidance is 
a result of that request. Specifically, this guidance is intended to 
provide recommendations to developers of CMI regarding how best to 
evaluate current CMI and develop future CMI to ensure that all CMI meet 
the usefulness criteria provided in the Action Plan. FDA welcomes 
comments on all the topics addressed by the guidance.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on useful 
written CMI. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
Submit a single copy of electronic comments or two paper copies of 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The draft guidance and received 
comments are available for public examination in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
    Dated: May 18, 2005.

Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-10445 Filed 5-25-05; 8:45 am]