[Federal Register: May 26, 2005 (Volume 70, Number 101)]
[Notices]
[Page 30467-30469]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26my05-85]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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Draft Guidance on Useful Written Consumer Medication Information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availability of a draft guidance entitled ``Useful Written Consumer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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Division of Dockets Management (HFA-305),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://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Ellen Tabak, Center for Drug
Evaluation and Research (HFD-410), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-7843.
SUPPLEMENTARY INFORMATION:
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FDA is announcing the availability of a draft guidance entitled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 This draft
guidance is intended to assist individuals or organizations (e.g.,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
medications.
---------------------------------------------------------------------------
\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://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
legibility.
---------------------------------------------------------------------------
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;
and
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
harm.
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://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://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
Guidance
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://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://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://www.fda.gov/cder/guidance/index.htm or 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]
BILLING CODE 4160-01-S