On June 12-13, 2007, FDA’s Center for Drug Evaluation and Research (CDER) will hold a public hearing to obtain feedback on FDA’s Medication Guide program, which provides for the distribution of FDA-approved written patient information for certain drug and biological products that pose serious and significant public health concerns. FDA is interested in obtaining public comment on ways to improve communication to patients who receive Medication Guides. The purpose of the public hearing is to solicit information and views from interested persons on specific issues associated with the development, distribution, comprehensibility, and accessibility of Medication Guides, which are required to convey risk information to patients.

Summary of Public Hearing on FDA's Use of Medication Guides to Distribute Drug Risk Information to Patients June 12-13, 2007

Dates:             June 12-13, 2007
Time:              8:30 a.m. – 4:30 p.m.
Location:        National Transportation and Safety Board (NTSB) Boardroom and Conference Center, 429 L’Enfant Plaza, SW, Washington, DC 20594. Metro: L’Enfant Plaza Station on the Green, Yellow, Blue, and Orange Lines.

• Federal Register Notice [TXT] [PDF]
• Agenda
• Transcripts
  • June 12
  • June 13
• FDA News: FDA to Hold Public Hearing on Medication Guide Program - Goal: Improving Risk Communication
• Medication Guide Web site
• Medication Guide Final Rule
• Presentations
  • Use of Medication Guides to Distribute Drug Risk Information to Patients, Marissa Craddock, Roxane Laboratories, Inc.
  • FDA Public Hearing Regarding Medication Guide Program Reform, Steve Heidenthal, R.Ph. CVS Caremark Corporation
  • Current Challenges for Medication Guide Distribution, Paul Johnson, R.Ph., Wolters Kluwer Health
  • Patient Receipt and Understanding of Written Information Provided with Isotretinoin Prescriptions, Nancy M. Allen LaPointe, Pharm. D., Duke University
  • Learnings from Consumer Research in Risk Communication, Kala L. Paul, M.D. The Corvallis Group
  • Presentation Lisa Van Syckel, Drugawareness
  • Health Literacy and Medication Safety: Can We Confuse Patients Less?, Michael S. Wolf, M.A., M.P.H., Ph.D., Northwestern University
  • FDA Flawed Gatekeeping, Vera Sharav, President, Alliance for Human Research Protection
  • Mandatory Drug Risk Information, Ruth S. Day, Duke University
  • Presentation, John M. Coster, Ph.D., R.Ph and Ronna Hauser, R.Ph., National Association of Chain Drug Stores (NACDS)
  • Presentation, Gerald K. McEvoy, Pharm.D. Assistant Vice President, Drug Information Editor in Chief, AHFS
  • Use of Medication Guides to Distribute Drug Risk Information to Patients, M. Alex Michaels, M.D.
  • Use of Medication Guides to Distribute Drug Risk Information to Patients, Bryan Ziegler, Pharm.D., M.B.A., NCPA

Submit written or electronic notices of participation (registration) and comments for consideration at the hearing by 4:30 p.m. on May 12, 2007. Written or electronic comments will be accepted after the hearing until July 12, 2007.

Send Comments:

• Mailing Address:

      Division of Dockets Management (HFA-305)
      Food and Drug Administration
      5630 Fishers Lane, Room 1061
      Rockville, Maryland  20852

• Internet: http://www.fda.gov/dockets/ecomments

Register to Attend and/or to Participate in the Public Hearing:

• Mailing Address:

      Division of Dockets Management (HFA-305)
      Food and Drug Administration
      5630 Fishers Lane, Room 1061
      Rockville, Maryland  20852

• Internet: http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm

Transcripts of the hearing will be available for review approximately 30 days after the hearing at the Division of Dockets Management and on the Internet at http://www.fda.gov/ohrms/dockets.

For further information, contact:
Mary C. Gross
Safety Policy and Communication Staff (HFD-001)
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland  20857
telephone: 301-443-5421
e-mail: mary.gross@fda.hhs.gov