[Federal Register Volume 75, Number 166 (Friday, August 27, 2010)]
[Notices]
[Pages 52765-52768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21326]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0437]


Development and Distribution of Patient Medication Information 
for Prescription Drugs; Public Hearing

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public hearing; request for comment.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing a 2-day 
public hearing to obtain input on a new framework for development and 
distribution of patient medication information (PMI) to be provided to 
patients who are prescribed drug products. Under the current system, 
patients may receive several different types of information, developed 
by different sources that may be duplicative, incomplete, or difficult 
to read and understand. FDA has determined that the current system is 
not adequate to ensure that patients receive the essential medication 
information that is needed to use the drug safely. Based on 
recommendations from FDA's Risk Communication Advisory Committee (RCAC) 
and other stakeholder input, FDA sees merit in adopting use of a single 
document that is standardized with respect to content and format. The 
purpose of this hearing is to solicit public input on processes and 
procedures for standardizing PMI using a quality system approach for 
monitoring development and distribution of PMI.

DATES: The public hearing will be held on September 27 and 28, 2010, 
from 8:30 a.m. to 4:30 p.m. Registration requests and requests to 
present at the public hearing should be received by September 13, 2010 
(see section III of this document for details). Electronic or written 
comments will be accepted after the public hearing until October 29, 
2010 (see section V of this document for details).

ADDRESSES:  The public hearing will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31, rm. 1503, Silver Spring, MD 20993. 
To register for the public hearing, email your registration information 
to <a href="/cdn-cgi/l/email-protection#c9998480b9bcaba5a0aaa4acacbda0a7ae89afada8e7a1a1bae7aea6bf"><span class="__cf_email__" data-cfemail="f4a4b9bd848196989d97999191809d9a93b4929095da9c9c87da939b82">[email protected]</span></a>. See section III of this document for 
registration details. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denise Hinton, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6348, Silver Spring, MD 20993, 301-796-
1090, FAX: 301-847-3529, email: <a href="/cdn-cgi/l/email-protection#f6a6bbbf8683949a9f959b9393829f9891b6909297d89e9e85d8919980"><span class="__cf_email__" data-cfemail="3f6f72764f4a5d53565c525a5a4b5651587f595b5e1157574c11585049">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    Ensuring that patients who are prescribed medical products have 
access to quality information about those products is an important 
component of medical product safety. Currently, patients receive 
multiple types of written prescription drug information in varying 
formats, which

[[Page 52766]]

complicates information accessibility and comprehension. The types of 
written prescription drug information include:
    <bullet> Consumer Medication Information (CMI) is written 
information about prescription drugs developed by organizations or 
individuals other than a drug manufacturer that is intended for 
distribution to consumers at the time of drug dispensing. The 
information is not FDA reviewed or approved and is voluntarily 
distributed by pharmacies to consumers (Ref. 1).
    <bullet> A Patient Package Insert (PPI) is patient labeling that is 
part of the FDA-approved prescription drug labeling. PPIs are developed 
by the manufacturer, approved by FDA, and are required to be dispensed 
with specific products or classes of products (i.e., oral 
contraceptives and estrogen-containing products). Other PPIs are 
submitted to FDA voluntarily by the manufacturer and approved by FDA, 
but their distribution is not mandated.
    <bullet> A Medication Guide is also patient labeling that is part 
of the FDA-approved prescription drug labeling. Medication Guides are 
required for certain drugs ``that pose a serious and significant public 
health concern'' (see 21 CFR part 208). Medication Guides are developed 
by the manufacturer, approved by FDA, and are required to be given to 
patients each time the medication is dispensed.
    By objective measures, current systems for providing high quality, 
easily accessible prescription medication information to patients have 
failed. For example, an evaluation of CMI in 2008 showed that while 94 
percent of consumers receive CMI with new prescriptions, only 75 
percent of CMI received met even minimum criteria for usefulness (Ref 
2.). FDA presented these concerns to the RCAC at a February 26 and 27, 
2009 meeting. That committee recommended that FDA adopt a standard, 
single document for communicating essential information about 
prescription drugs to replace CMI, PPIs, and Medication Guides. FDA is 
engaged in a collaborative effort to explore this recommendation.
    The major challenges in providing patients with quality 
prescription drug information are as follows: (1) Development of 
uniform, evidence-based content and format standards for PMI, including 
that the PMI contains the essential information about the drug, and is 
accurate, balanced, comprehensible, and accessible; (2) identification 
and assessment of mechanisms to ensure that PMI meets these standards; 
and (3) identification and assessment of mechanisms to ensure that the 
PMI reaches its target audience. This public hearing is intended to 
focus primarily on issues 2 and 3, and related issues, while the first 
issue is being addressed separately, as discussed in the following 
paragraphs.
    There are two key limitations that underpin FDA's expectations for 
how improvements in providing patient information might be structured. 
First, although one approach could include FDA review and approval of 
all PMI prior to distribution, FDA recognizes that this may not be 
feasible given FDA's resource constraints and the potential volume of 
products that will require PMI (perhaps as many 22,000 if counting all 
innovator and generic products). Second, based on FDA's compliance and 
enforcement experience in a variety of program areas, including 
professional labeling, manufacturing, and clinical trials, FDA 
recognizes that relying primarily or exclusively on retrospective 
Agency evaluations and inspections may not be an optimal approach to 
providing assurance that PMI meets format and content standards prior 
to distribution to patients. For these reasons, FDA is interested in 
exploring an approach centered on effective processes for PMI 
development and distribution and process controls for a PMI 
implementation program. With a system in place that assures high 
quality PMI, FDA believes that development of PMI by the manufacturer 
would be more efficient and fulfill the information needs of patients.
    Such an approach for PMI would provide manufacturers with a quality 
framework for developing, distributing, and amending PMI and would 
facilitate continual improvement of PMI. FDA envisions that this 
approach would provide assurance that manufacturers have implemented 
the following: (1) Effective procedures for developing PMI that reflect 
quality standards for PMI content and format, for ensuring appropriate 
distribution, and for ensuring PMI revision if necessary; (2) 
mechanisms to monitor whether these procedures are being followed; and 
(3) mechanisms to implement process changes as needed.
    Because it will take a substantial amount of time to transition 
from the existing system to the use of a standard, single document for 
PMI, FDA is also seeking public input on a potential structure and 
challenges and solutions for a step-wise transition to a new PMI 
paradigm.
    As described in the explanation of major challenges earlier in this 
document, FDA is also continuing its efforts and seeking additional 
information to identify and assess the development of format and 
content standards for PMI as a standard, single document. With input 
from the following sources FDA has developed three draft PMI prototypes 
to be used in consumer testing:
    (1) FDA's RCAC meeting (Ref. 3);
    (2) a public workshop held on September 24 and 25, 2009 (available 
at http://www.fda.gov/Drugs/NewsEvents/ucm168106.htm); and
    (3) an expert panel meeting convened by the Brookings Institute on 
July 21, 2010 (available at http://www.brookings.edu/events/2010/0721_CMI.aspx),\1\
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    \1\ 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.
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Based on public comment (75 FR 23775, May 4, 2010) and expert panel 
input, FDA is also finalizing the design of the consumer testing study 
for the prototypes (available on the Internet at http://edocket.access.gpo.gov/2010/pdf/2010-10359.pdf). Consumer testing will 
begin when the final study design is approved by the Office of 
Management and Budget. The results of this study will inform FDA of the 
usefulness and parameters of various format options for patient 
information documents. FDA is interested in any formal research 
conducted on this topic and encourages submission to this docket. See 
section III of this document for details on how to register and or 
participate in the meeting. See section V of this document for details 
on how to post comments to the docket.

II. Scope of the Hearing

    FDA is particularly interested in seeking input on the following 
issues:
    (1) How can we best ensure PMI quality and compliance with content 
and format criteria?
    <bullet> What are the elements that should be addressed with a 
quality system approach, or other type of system, to ensure PMI 
quality?
    <bullet> What functions and procedures should be the responsibility 
of manufacturers (e.g., PMI development, consumer testing, marketplace 
surveillance)?
    <bullet> What functions and procedures should be FDA's 
responsibility (e.g., surveillance, audit, enforcement)?
    <bullet> Are there a subset of products that should receive more 
regulatory scrutiny than would be provided by an approach that relies 
heavily on manufacturers implementing and monitoring the adequacy of 
procedures for generating PMI content (i.e., types of products for

[[Page 52767]]

which PMI should be prospectively reviewed and approved by FDA before 
use)? If so, what categories of drugs might be included in this subset? 
What other approaches to ensuring quality should be considered for 
drugs in this subset?
    <bullet> At what time-point should evaluation of the PMI be 
initiated and how often should it be repeated?
    (2) What are the components of an effective framework for ensuring 
patient access to PMI?
    <bullet> Who should be responsible for processes to ensure 
distribution of PMI?
    <bullet> What types of processes are needed to ensure distribution 
of PMI? For example, should there be a process or system to monitor 
patient receipt of PMI?
    <bullet> How can we ensure adequate distribution of PMI while 
minimizing disruption to health care delivery processes (e.g., medical 
practice, pharmacy practice)?
    <bullet> Are there situations where the distribution of PMI would 
not be appropriate (e.g., for medications administered by a health care 
professional in an inpatient or outpatient setting, dialysis unit, 
oncology setting, or operating room)?
    <bullet> Should there be a centralized repository for all PMI? If 
so, how might a repository be implemented and maintained to ensure the 
integrity and sustainability of the repository? Are there relevant, 
existing systems that could serve as a business model for a central PMI 
repository?
    (3) What approaches should be considered to ensure that FDA can 
rapidly move from the current system to a new PMI paradigm?
    <bullet> How might the existing framework be phased if a new 
framework is phased in?
    <bullet> How should a new PMI system be applied to generic drugs?
    (4) What accommodations might be needed to ensure that PMI is 
accessible to special populations (e.g., elderly, children, those with 
low literacy, the visually impaired)?

III. How to Register and/or Participate in the Public Hearing

    FDA is seeking input from a broad group of stakeholders, including 
interested prescribers, pharmacists, other health care professionals, 
consumers, pharmacies, CMI developers, publishers, industry, and any 
other interested parties. FDA's Conference Center at the White Oak 
Campus is a Federal facility with security procedures and limited 
seating. Attendance is free and will be on a first-come, first-served 
basis. To register for the public hearing, email your registration to 
<a href="/cdn-cgi/l/email-protection#39697470494c5b55505a545c5c4d50575e795f5d581751514a175e564f"><span class="__cf_email__" data-cfemail="76263b3f0603141a1f151b1313021f181136101217581e1e0558111900">[email protected]</span></a>. Registration information should include 
registrant name, company or organization, address, phone number, and 
email address. Because seating is limited, FDA may limit the numbers of 
participants from each organization. Registrants will receive 
confirmation once they have been accepted for participation in the 
workshop. Onsite registration on the day of the hearing will be based 
on space availability on the day of the event starting at 7:30 a.m. If 
registration reaches maximum capacity, FDA will post a notice closing 
meeting registration for the hearing at http://www.fda.gov/Drugs/NewsEvents/ucm219716.htm.
    Individuals who wish to present at the public hearing must register 
on or before September 13, 2010, through the email 
<a href="/cdn-cgi/l/email-protection#99c9d4d0e9ecfbf5f0faf4fcfcedf0f7fed9fffdf8b7f1f1eab7fef6ef"><span class="__cf_email__" data-cfemail="0b5b46427b7e69676268666e6e7f62656c4b6d6f6a25636378256c647d">[email protected]</span></a>, and state this intention on their notice 
of participation. An abstract of the presentation along with slides are 
due on September 17, 2010. You must provide complete contact 
information, including name, title, affiliation, address, email, and 
phone number. In section II of this document, FDA has included 
questions for comment. You should identify by number each question you 
wish to address in your presentation, so that FDA can consider that in 
organizing the presentations. FDA will do its best to accommodate 
requests to speak, and will determine the amount of time allotted to 
each presenter and the approximate time that each oral presentation is 
scheduled to begin. An agenda will be available approximately 1 week 
before the hearing at http://www.fda.gov/Drugs/NewsEvents/ucm219716.htm.
    If you need special accommodations because of disability, please 
contact Denise Hinton (see FOR FURTHER INFORMATION CONTACT) at least 7 
days before the hearing.
    A live webcast of this hearing will be viewable at https://collaboration.fda.gov/p15d109272010/ on September 27 and https://collaboration.fda.gov/p15d209272010/ on September 28. If you have never 
attended an Adobe[reg] Acrobat[reg] Connect\TM\ Pro meeting before, 
test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. For a quick overview, go to http://www.adobe.com/go/connectpro_overview.

IV. Notice of Hearing Under Part 15

    The Commissioner of Food and Drugs is announcing that the public 
hearing will be held in accordance with part 15 (21 CFR part 15). The 
hearing will be conducted by a presiding officer, who will be 
accompanied by senior management from the Office of the Commissioner, 
the Center for Drug Evaluation and Research, and the Center for 
Biologics and Research.
    Under Sec.  15.30(f), the hearing is informal and the rules of 
evidence do not apply. No participant may interrupt the presentation of 
another participant. Only the presiding officer and panel members may 
question any person during or at the conclusion of each presentation. 
Public hearings under part 15 are subject to FDA's policy and 
procedures for electronic media coverage of FDA's public administrative 
proceedings (part 10, subpart C (21 CFR part 10, subpart C)). Under 
Sec.  10.205, representatives of the electronic media may be permitted, 
subject to certain limitations, to videotape, film, or otherwise record 
FDA's public administrative proceedings, including presentations by 
participants. The hearing will be transcribed as stipulated in Sec.  
15.30(b) (see section VI of this document). To the extent that the 
conditions for the hearing, as described in this notice, conflict with 
any provisions set out in part 15, this notice acts as a waiver of 
those provisions as specified in Sec.  15.30(h).

V. Comments

    Regardless of attendance at the public hearing, interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) either 
electronic or written comments. It is only necessary to send one set of 
comments. It is no longer necessary to send two copies of mailed 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. To ensure consideration, submit comments 
by October 29, 2010. Received comments may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

VI. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov. It may be viewed at 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information (HFI-35), Office 
of Management Programs, Food and

[[Page 52768]]

Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857.

VII. References

    1. ``Useful Written Consumer Medication Information (CMI)'' 
published in July 2006, available on the Internet at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080602.pdf.
    2. Kimberlin CL, Winterstein AG. ``Expert and Consumer Evaluation 
of Consumer Medication Information--2008.'' Final Report to FDA. 
November 2008 available on the Internet at http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ReportsBudgets/UCM163783.pdf.
    3. FDA's Risk Communication Advisory Committee meeting, held on 
February 26 and 27, 2009 (73 FR 74505, December 8, 2008), available on 
the Internet at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/UCM152593.pdf.
    4. ``Providing Effective Information to Consumers about 
Prescription Drug Risks and Benefits--The Issues Paper'' from the 2009 
public workshop available on the Internet at http://www.fda.gov/downloads/Drugs/NewsEvents/UCM182799.pdf.
    5. ``Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Study of Patient Information 
Prototypes,'' available on the Internet at\2\ http://edocket.access.gpo.gov/2010/pdf/2010-10359.pdf
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    \2\ 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.

    Dated: August 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-21326 Filed 8-26-10; 8:45 am]
BILLING CODE 4160-01-S


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