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U.S. Department of Health and Human Services

Drugs

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

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), which is 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.

Date(s):    September 27-28, 2010
Time:        8:30 a.m. to 4:30 p.m.
Location:   FDA White Oak Campus
                10903 New Hampshire Ave, Building 31, Room 1503
                Silver Spring, Maryland 20993

Visitor Information
All meeting attendees must enter through Building 1 on the FDA White Oak Campus. Parking is available in the Southeast surface lot and a shuttle bus will be available to bring attendees from the lot to Building 1. Please see Directions/Transportation/Parking/Hotels for the FDA White Oak Campus (PDF - 115KB) for directions and further details about transportation and lodging. Map of White Oak Visitor Parking (PDF - 105KB) for directions.
 

Webcast of Meeting

For those unable to attend in person, the meeting will also be webcast using Adobe Connect Pro. Watch the webcast on September 27 and September 28 from 8:30 am to 4:30 pm. We will not be able to accommodate questions from those participating via webcast.

To join the meeting use the following links:
https://collaboration.fda.gov/p15d109272010/ on September 27 and
https://collaboration.fda.gov/p15d209272010/ on September 28.

Recording of the Meeting

Part 15 Public Hearing: Patient Labeling / Consumer Medication Information
(Day 1): https://collaboration.fda.gov/p59962108/

Part 15 Public Hearing: Patient Labeling / Consumer Medication Information
(Day 2): https://collaboration.fda.gov/p68787723/

If you have never attended an Adobe Connect Pro meeting before, test your connection at: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm

For a quick overview of Adobe Connect Pro, go to: http://www.adobe.com/go/connectpro_overviewdisclaimer icon

Important information about using Adobe Connect Pro:
• View meetings on Windows, Macs, Unix, and Linux platforms
• Lan or Broadband internet connection
• Supports Internet Explorer, Firefox, Safari, Netscape Navigator, AOL
• Adobe Flash Player (no other downloads needed)
• VPN and Parachute compatible but not required
 

Attendance and Registration to Speak

The FDA Conference Center at the White Oak location is a federal facility with limited seating so attendance will be on a first come-first served basis. To register for the public hearing, email your registration to PMIpublicmeeting@fda.hhs.gov.  Registration information should include registrant name, company or organization, address, phone number, and email address.  Because seating is limited, FDA may limit the number of participants from each organization. Registrants will receive confirmation once they have been accepted for participation in the workshop.

Individuals who wish to speak must register by sending an e-mail to PMIpublicmeeting@fda.hhs.gov on or before September 17, 2010 and provide complete contact information for each speaker, including name, title, affiliation, address, e-mail, and phone number.  An abstract of the presentation along with slides are due on or before September 17, 2010. 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. 

If you need special accommodations because of disability, please contact Denise Hinton, Center for Drug Evaluation and Research, Food and Drug Administration, phone (301)796-1090, e-mail PMIpublicmeeting@fda.hhs.gov at least 7 days before the meeting.