[Federal Register: May 23, 2007 (Volume 72, Number 99)]
[Page 28976-28977]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Agency for Healthcare Research and Quality

Food and Drug Administration

[Docket No. 2007N-0179]

Implementation of Risk Minimization Action Plans (RiskMAPs) to 
Support Quality Use of Pharmaceuticals: Opportunities and Challenges; 
Public Workshop

AGENCIES: Agency for Healthcare Research and Quality; Food and Drug 
Administration, HHS.

ACTION: Notice of public workshop; request for comments.


SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) and the 
Food and Drug Administration (FDA) are announcing a 2-day joint public 
workshop entitled ``Implementation of Risk Minimization Action Plans 
(RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and 
Challenges.'' This public workshop is intended to seek constructive 
input from a wide range of stakeholders, including clinicians, 
pharmacists, patients, third party payers of care, the pharmaceutical 
and biotechnology industries, researchers, and innovators in health 
information technology (HIT), to help in the development and 
implementation of mechanisms to minimize the risks of pharmaceuticals 
with unusual safety and patient monitoring concerns. This meeting is an 
initial step that is part of FDA's commitment to monitor the 
performance of RiskMAPs consistent with the goal articulated in the 
proposed PDUFA IV agreement to undertake regular follow up of these 

DATES: The public workshop will be held on June 25 and 26, 2007, from 
8:30 a.m. to 5 p.m. See section III of this document for information on 
deadline and on how to register to attend or present at the meeting.
    We are opening a docket to receive your written or electronic 
comments. Written or electronic comments must be submitted to the 
docket by July 31, 2007.

ADDRESSES: The public workshop will be held at the Agency for 
Healthcare Research and Quality (AHRQ), 540 Gaither Rd., John M. 
Eisenberg Bldg., Rockville, MD 20850. Submit electronic comments to 
 Submit written comments to the Division of Dockets 

Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. All comments should be identified with 
the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Lee Lemley, Center for Drug Evaluation 
and Research, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-5392, FAX: 301-827-4312, e-mail: 


I. Background

    Risk minimization action plans (RiskMAPs) are safety programs 
designed to minimize significant risks of a product by using one or 
more risk minimization tools. A variety of risk minimization tools have 
been used; these tools are broadly categorized as follows: (1) 
Education and outreach tools intended to inform patients and healthcare 
practitioners (HCPs) about a product's risks and measures that should 
be taken to prevent or mitigate the risks; (2) Reminder systems 
intended to prompt or guide HCPs and/or patients in prescribing, 
dispensing, or

[[Page 28977]]

using a product in ways that minimize risk; and (3) performance-linked 
access (PLA) systems that link product access to required laboratory 
testing or other documentation. The latter two categories have 
exhibited some success in minimizing risk, but may lead to disruptions 
in medical and pharmacy practice and unintended consequences, such as 
obstructing patient access to a product's benefits. It is the latter 
two tool categories (Reminder and PLA systems) that are the primary 
focus of this workshop. The following are a few of the products with 
Reminder or PLA systems: Isotretinoin (iPLEDGE), Thalidomide (STEPS), 
and Tysabri (TOUCH).
    The workshop objectives are as follows: (1) Initiate constructive 
dialogue and information-sharing among regulators, researchers, and 
organizations and individuals affected by RiskMAP programs, 
particularly those using Reminder and PLA systems; (2) share key 
lessons learned about how to design and implement effective risk 
management systems to accommodate and promote quality healthcare and 
pharmacy practices; and (3) explore how tools being actively developed 
(such as electronic prescribing and integrated electronic health and 
medical records) and used to support high-quality, evidence-based 
practice may improve the development of RiskMAPs where Reminder and PLA 
systems are used or being considered for use.
    Panel discussions as well as stakeholder presentations and 
testimony will focus on implementation strategies using Reminder and 
PLA systems to promote appropriate behavior changes to optimize patient 
outcomes, autonomy, access, cost, and logistics while reducing drug 
risks. We invite presentations that suggest ways to mitigate drug 
safety risks by improving healthcare system processes or emerging 
health information technologies. Examples might include linkages of 
electronic prescribing to laboratory or to patient electronic health 
records designed to improve the effectiveness of risk minimization 
    AHRQ and FDA are working together to refine the conference agenda 
and invite speakers. The agenda will be made available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/meeting/riskMAPs.htm
 not later than June 15, 2007. We 

are seeking broad participation by physicians, pharmacists, patients, 
health care quality and safety researchers, health systems officials, 
and payers of care. We anticipate issuing a summary of the conference 
findings, including a discussion of implications and next steps for 
further research or regulatory guidance development.

II. Comments

    The agency is interested in hearing comments at the public workshop 
or receiving written comments (see ADDRESSES) on the following issues:
    (1) Based on the diversity of experiences of different groups in 
implementing existing Reminder and PLA system RiskMAPs, what lessons 
have been learned that can be applied to future programs in the 
following areas:
     Minimizing risks;
     Maintaining provider and patient access to therapeutic 
     Minimizing burdens on the healthcare system;
     Being compatible with diverse technologies and settings of 
     Avoiding adverse unintended consequences.
    (2) How can healthcare information technology be used to assist 
quality prescribing, dispensing, and patient use to improve the 
effectiveness of RiskMAPs for drugs with risks where Reminder and PLA 
systems are used or likely to be used? How might HIT solutions be 
pursued and applied in light of the underdeveloped use of this 
technology in healthcare?
    (3) How might professional organizations, third party payers of 
care, and others support the appropriate use of medications with 
processes or requirements such as those used with Reminder and PLA 
system RiskMAPs?
    (4) Who are the relevant stakeholders in healthcare to involve in 
the design and choice of risk minimization tools? How can these 
stakeholders be best engaged in meaningful and productive partnerships 
and collaborations?
    (5) Which activities and research should be pursued to develop a 
strong evidence base of healthcare system approaches, processes, and 
tools that support appropriate use of medications with safety problems 
where Reminder and PLA RiskMAPs are being used or considered for use?
    (6) What partnerships will support evaluations of effectiveness of 
RiskMAPs or pilot interventions to minimize risk and promote 
appropriate medication prescribing, dispensing, and use?
    (7) What future actions should AHRQ and FDA take to promote 
continued collaborations and contributions to the high-quality, 
appropriate use of medications with RiskMAPs?

III. Registration

    The AHRQ Conference Center is a Federal facility with limited 
seating and security procedures for entrance. For these reasons, pre-
registration is necessary for all attendees. Registration is available 
on a first-come basis. Individuals who wish to speak during the open 
public hearing must register on or before June 8, 2007; all other 
attendees must register on or before June 15, 2007. To register, 
contact register@consolidatedsafety.com or call 703-877-3345.
    Ample time will be allowed during the scheduled agenda for 
attendees to ask questions of panelists. In addition, we strongly 
encourage written comments to the docket.
    If you need special accommodations because of disability, please 
contact Lee Lemley (see CONTACT FOR FURTHER INFORMATION) at least 7 
days before the workshop.

IV. Workshop Transcripts

    The workshop will be transcribed. The transcript will be available 
for review at the Division of Dockets Management (see ADDRESSES) and 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 approximately 30 days 

after the workshop.

    Dated: May 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.

    Dated: May 16, 2007.
Carolyn Clancy,
Director, Agency for Healthcare Research and Quality, Department of 
Health and Human Services.
[FR Doc. 07-2574 Filed 5-22-07; 8:45 am]