
[Federal Register Volume 78, Number 154 (Friday, August 9, 2013)]
[Notices]
[Pages 48691-48692]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19275]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Food and Drug Administration Patient Network Annual Meeting; 
Demystifying Food and Drug Administration: An Exploration of Drug 
Development Hosted by the Food and Drug Administration Office of Health 
and Constituent Affairs, Formerly the Office of Special Health Issues

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a meeting 
for patients, caregivers, patient advocates, as well as patient 
advocate and health professional groups, to provide a primer on drug 
product development and explore patient involvement in drug 
development. The meeting will serve as a forum for FDA's patient 
stakeholders and the general public, including health professionals, 
academia, and industry to learn about FDA's role in, and various 
regulatory issues related to drug development, analyze where in the 
process patient input may be most practical and most valuable, and 
explore practicable approaches to incorporating meaningful patient 
input that will represent broad patient perspectives in drug 
development and regulatory decision making. Specifically, this meeting 
will provide information and facilitate a discussion about: FDA's role 
in drug development and where and how patients can take an active role.

DATES: The meeting will be held on September 10, 2013, from 8:30 a.m. 
to 4:30 p.m. Register to attend the conference at http://www.patientnetwork.fda.gov/patient-network-annual-meeting-September-10-2013 on or before August 27, 2013. There is no registration fee for 
this conference. Early registration is suggested because space is 
limited. The conference will be available for viewing via Webcast 
please register at for the Webcast at http://www.patientnetwork.fda.gov/patient-network-annual-meeting-September-10-2013. We request that organizations limit the number of representatives 
to two. For further registration information or problems with 
registering call Cindy de Sales at 240-316-3200 ext. 207.
    If you need special accommodations due to a disability, please 
specify those accommodations when registering for this 1-day 
conference.

[[Page 48692]]


ADDRESSES: The meeting will be held at the Washington Marriott at Metro 
Center 775 12th St. NW., Washington DC 20001.

FOR FURTHER INFORMATION CONTACT: Steve Morin, Office of Health and 
Constituent Affairs, 10903 New Hampshire Ave., Silver Spring, MD 20993, 
301-796-0161, FAX: 301-847-8623, email: Steve.Morin@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. The FDA Patient Network

    This is the second FDA Patient Network Annual Meeting hosted by the 
FDA Office of Health and Constituent Affairs, formerly the Office of 
Special Health Issues, the Agency's primary liaison with patient and 
health professional communities. This annual meeting is being hosted as 
part of the larger FDA Patient Network program. The FDA Patient Network 
is a new resource for patients, caregivers, independent patient 
advocates, and patient advocate groups that seeks to:
     Educate and inform patient stakeholders about FDA, its 
regulatory authorities and processes, its initiatives and programs, and
     Provide a venue for advocacy for patient stakeholder 
involvement within FDA, enhancing transparency of Agency actions for 
patients. In addition to an annual meeting, the FDA Patient Network 
consists of:
     The FDA Patient Network Web site--A new, patient-centered 
Web site that contains educational modules, centralized Agency 
information, and multi-directional communication tools 
(www.patientnetwork.fda.gov);
     The biweekly FDA Patient Network News email newsletter 
containing FDA-related information on a variety of topics, including 
new product approvals, significant labeling changes, safety warnings, 
notices of upcoming public meetings, proposed regulatory guidances and 
opportunity to comment, and other information of interest to patients 
and patient advocates; and
     Hosting of periodic meetings, briefings, and listening 
sessions between patient advocates and FDA staff.

II. Patient Involvement in the Drug Development Life Cycle

    We believe that enhancing patients' understanding of the drug 
development process will provide a better foundation for their 
participation in regulatory decision making, and clarify where patient 
input can be most meaningful in the drug development life cycle. 
Patients who live with a disease have a direct stake in the development 
of new therapies to treat and minimize symptoms they are experiencing. 
They are in a unique position to contribute to the various product-
specific regulatory decisions that occur throughout the drug 
development process, as well as the policy decisions that impact the 
drug development and review paradigm. Though several programs exist 
that facilitate patient representation on Advisory Committees or 
participation in selected review meetings, there are currently few 
venues in which the patient perspective is discussed outside of a 
specific product's marketing application review. FDA believes the 
medical product review process could benefit from a more scientific, 
systematic, and expansive approach to obtaining input from patients who 
are experiencing a particular disease condition.
    As part of the Food and Drug Administration Safety and Innovation 
Act, specifically section 1137 (see: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm311045.htm), FDA is tasked 
with developing and implementing strategies to solicit the views of 
patients during the medical product development process and consider 
their perspectives during regulatory discussions. This includes:
     Fostering participation of FDA Patient Representatives as 
Special Government Employees in appropriate Agency meetings with 
medical product sponsors and investigators; and
     Exploring means to provide for identification of potential 
FDA Patient Representatives who do not have any, or have minimal, 
financial interest in the medical products industry.
    FDA is conducting this meeting with patients, caregivers, patient 
advocates, and patient advocate groups to provide a forum to demystify 
the drug development process and FDA's role in drug regulation, and 
facilitate a discussion between these stakeholders and the Agency to 
foster a collaborative relationship. This meeting, intended to build 
upon the objectives of the inaugural Patient Network Annual Meeting, 
held on May 18, 2012, will provide an open forum for patients and 
patient advocates to engage with FDA on both ongoing and emerging 
medical product regulatory issues.

    Dated: August 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19275 Filed 8-8-13; 8:45 am]
BILLING CODE 4160-01-P


