June 27, 2003

Christine Bechtel

Center for Drug Evaluation and Research

(HFD-006)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

# RE: Docket No. 03N-0168

Public Meeting: Useful Written Prescription Drug Information for
Consumers

Dear Ms. Bechtel:

The National Council on Patient Information and Education (NCPIE) would
like to request time to present at the above referenced public meeting.
Since our inception in 1982, NCPIE has encouraged and supported private
sector initiatives to more fully educate and inform the public about
appropriate use of prescription medications. With over 135 members,
NCPIE represents numerous private sector groups devoted to enhancing
prescription drug information for patients and consumers (see attached
roster). Since the passage of PL 104 -180 and our participation on the
Keystone Committee, NCPIE has doubled its efforts to provide
coordinating and facilitating functions for private sector initiatives
to meet the goals set forth. In recent months, we have begun developing
a coherent plan, that when implemented, can meet the Year 2006 goals.
This new effort represents the combined efforts of 17 private sector
medicine information stakeholders.

At the public meeting, we would like to present a series of
presentations that describe a detailed plan for meeting the quantity and
quality goals for the development and distribution of consumer
medication information. Specifically, we request one hour and 15 minutes
in presentation time. Although we request a single block of time, the
presentations will be divided among five different speakers. The time
and topics to be discussed will be organized as follows:

[Topic/Speaker/Time Requested]{.underline} [FDA Questions
Addressed]{.underline}

I. Background and Introductory Remarks 1 and 4

Ms. Linda Golodner (15 minutes)

Chairperson, NCPIE

Christine Bechtel

June 27, 2003

Page 2

[Topic/Speaker/Time Requested]{.underline} [FDA Questions
Addressed]{.underline}

2\. Presentation of the Criteria Committee

Speaker to be Determined (15 minutes) 2

3\. Presentation of the Education Committee

Speaker to be Determined (15 minutes) 3

4\. Presentation of the Implementation Committee

Speaker to be Determined (15 minutes) 1

5\. Summary and Next Steps

Mr. William Ray Bullman (15 minutes) 1 -- 4

Executive Vice President, NCPIE

We will forward to you a complete listing of speakers within the next
two weeks. All correspondence to individual speakers should be directed
to me at NCPIE. If you have any questions, please contact me directly.

Thank you for your attention to this matter.

Sincerely

> William Ray Bullman, M.A.M.\
> Executive Vice President\
> National Council on Patient\
> Information and Education (NCPIE)\
> 4915 Saint Elmo Ave., Suite 505\
> Bethesda, MD  20814-6082\
> (301) 656-8565, ext, 14 - phone\
> (301) 656-4464 - fax\
> <bullman@ncpie.info> - email

Attachment: NCPIE Membership Roster

### Members

**National Council on Patient Information and Education (NCPIE)**

**[Consumer Organizations]{.underline}**\
[AARP](http://www.aarp.org/)\*\
[Allergy & Asthma Network, Mothers of
Asthmatics](http://www.aanma.org/)\
[American Cancer Society](http://www.cancer.org/)\*\
[American Heart Association](http://www.americanheart.org/)\*\
[Cabarrus County Department of
Aging](http://www.co.cabarrus.nc.us/Pages/Aging/AG_Calendar.html)\
[Cancer Care, Inc.](http://www.cancercare.org/)\
[Council on Family Health](http://www.cfhinfo.org/)\
[Epilepsy Foundation of America](http://www.epilepsyfoundation.org/)\*\
[The Hormone Foundation](http://www.hormone.org/)\
[The Leukemia and Lymphoma Society of
America](http://www.leukemia-lymphoma.org/)\
[National Consumers League](http://www.nclnet.org/)\*\
[National Organization for Rare Disorders,
Inc.](http://www.rarediseases.org/)\
[National Osteoporosis Foundation](http://www.nof.org/)\*\
[National Parkinson Foundation](http://www.parkinson.org/)\
[Partnership for Caring, Inc.](http://www.partnershipforcaring.org/)\
[Prescriptions Anonymous, Inc.](http://www.prescriptionanonymous.org/)\
[Prevent Blindness America](http://www.preventblindness.org/)\*\
[Rx Council of Western Pennsylvania](http://trfn.clpgh.org/rxcouncil)\
[SMART Coalition of California](http://www.smartcoaltion.com/)\
[Society for Women\'s Health Research](http://www.womens-health.org/)\*\
[Y-me National Breast Cancer Organization](http://www.y-me.org/)

**[Business Organizations]{.underline}**\
[American Association of Health Plans](http://www.aahp.org/)\
[Bayer Pharmaceuticals](http://www.bayerpharma-na.com/)\
[Blue Cross of California](http://www.bluecrossca.com/)\
Cerner Multum

[CoMed Communications/PatientMatters](http://www.patientmatters.com/)\
Comedex\
[ComputerTalk Associates, Inc.](http://www.computertalk.com/)\
[Consumer Health Information
Corporation](http://consumer-health.com/)\*\
[Consumer Healthcare Products Association](http://www.chpa-info.org/)\
[First DataBank](http://www.firstdatabank.com/)\
[Generic Pharmaceutical Association](http://www.gphaonline.org/)\*\
[Government Employees Hospital Association](http://www.geha.com/)\
[Health Resource Publishing Company](http://www.healthresource.net/)\
[Healthcare Compliance Packaging Council](http://www.unitdose.org/)\
[Hogan & Hartson, L.L.P.](http://www.hhlaw.com/)\
[Johnson & Johnson](http://www.jnj.com/)\
[Kids\'n Cures, Inc.](http://www.kidsncures.com/)\
[Med Time Technology, Inc.](http://ThePillTimer.com/)\
[Medical Care & Outcomes, Inc.](http://www.mco-inc.com/)\*\
[Merck & Company, Inc.](http://www.merck.com/)\
[Merck-Medco Managed Care, LLC](http://www.merck-medco.com/)\
[Thomson MICROMEDEX](http://www.micromedex.com/)\
[Modern Health for Women](http://www.modernhealthforwomen.com/)\
[Monthly Prescribing Reference](http://www.prescribingreference.com/)\
[National Association of Chain Drug Stores
Foundation](http://www.nacds.org/)\*\
[National Pharmaceutical Council](http://www.npcnow.org/)\*\
[Novartis Pharmaceuticals
Corporation](http://www.pharma.us.novartis.com/)\*\
[Pfizer, Inc.](http://www.pfizer.com/)\
[Pharmaceutical Care Management Association](http://www.pcmanet.org/)\*\
[Pharmaceutical Research and Manufacturers of
America](http://www.phrma.org/)\
[Procter & Gamble](http://www.pgpharma.com/)\
[Purdue Pharma L.P.](http://www.purduepharma.com/)\
[RAD-AR Council, Japan](http://www.rad-ar.or.jp/english/index.html)\
[Roche](http://www.rocheusa.com/)\*

ScriptChek Visual Verification Systems, Inc.\
Senior Medicine

WoltersKluwer Health

#### Health Care Professional Organizations

[Academy of Managed Care Pharmacy](http://www.amcp.org/)\
[American Academy of Physician Assistants](http://www.aapa.org/)\*\
[American Association of Colleges of
Nursing](http://www.aacn.nche.edu/index.htm)\
[American Association of Colleges of Pharmacy](http://www.aacp.org/)\
[American Association of Nurse Anesthetists](http://www.aana.com/)\
[American College of Apothecaries](http://www.acinfo.org/)\
[American College of Clinical Pharmacy](http://www.accp.com/)\
[American Foundation for Pharmaceutical
Education](http://www.afpenet.org/)\
[American Medical Association](http://www.ama-assn.org/)\*\
[American Nurses Association](http://www.nursingworld.org/)\*\
[American Pharmacists Association](http://www.aphanet.org/)\*\
[American Psychological Association](http://www.apa.org/)\
[American Society of Consultant Pharmacists\
](http://www.ascp.com/)[American Society of Health-System
Pharmacists](http://www.ashp.org/)\
Arkansas Medical Society\
[Association of Clinicians for the
Underserved](http://www.clinicians.org/)\
[Association of periOperative Registered Nurses](http://www.aorn.org/)\
[Auburn University, Harrison School of
Pharmacy](../%20http://pharmacy.auburn.edu)\
[Bristol Hospital (CT)](http://www.bristolhospital.org/)\
[Chicago College of Pharmacy, Midwestern
University](http://www.midwestern.edu/Pages/CCP.html)\
[Creighton University, School of Pharmacy](http://spahp.creighton.edu/)\
[Florida A & M University, College of
Pharmacy](http://www.pharmacy.famu.edu/)\
[Georgia Pharmacy Association](http://www.gpha.org/)\
[Government Employees Health Association](http://www.geha.com/)\
[Idaho State University, College of Pharmacy](http://rx.isu.edu/)\
[Indiana State Medical Society](http://www.ismanet.org/)\
Institute for Medication Access & Compliance\
[Institute for Safe Medication Practices](http://www.ismp.org/)\
Jeanes Hospital (PA)\
[Massachusetts College of Pharmacy Health](http://www.massmedline.com/)\
   [Education & Resource Center](http://www.massmedline.com/)\
[Mercer University, Southern School of
Pharmacy](http://www.mercer.edu/pharmacy)\
[Michigan Pharmacists Association](http://www.mipharm.com/)\
[Missouri Pharmacy Association](http://www.morx.com/)\
[National Community Pharmacists Association](http://www.ncpanet.org/)\*\
[National Council of State Pharmacy Association Executives
(NCSPAE)](http://www.ncspae.org/)\
[National Medical Association](http://www.nmanet.org/)\*\
[New York University College of Dentistry](http://www.nyu.edu/dental)\
[North Dakota Pharmaceutical
Association](http://www.nodakpharmacy.com/)\
[Nova Southeastern University, College of
Pharmacy](http://www.nova.edu/cwis/centers/hpd/pharmacy)\
Nurse Associate Educational Services\
[Oncology Nursing Society](http://www.ons.org/)\
Prescription Drug Consulting Services, Inc.\
[Peter Lamy Center for Drug Therapy and
Aging](http://www.pharmacy.umaryland.edu/lamy/)\*\
[Program for Patient Safety](http://tamushsc.tamu.edu/)\
[Regenstrief Institute](http://www.regenstrief.org/)\
[Shenandoah University School of
Pharmacy](http://pharmacy.su.edu/index.html)\
[Sigma Theta Tau International](http://www.nursingsociety.org/)\
[St. Louis College of Pharmacy](http://www.stlcop.edu/)\
[Temple University School of Pharmacy, Center for Pharmaceutical Health
Services Research](http://www.temple.edu/pharmacy/)\
[Tennessee Pharmacists Association](http://www.tnpharm.org/)\
[Texas A & M University](http://www.tamu.edu/)\
[Texas Pharmacy Association](http://www.txpharmacy.com/)\
[University of Connecticut, School of
Pharmacy](http://www.ucc.uconn.edu/~wwwpharm)\
[University of Illinois at Chicago, College of Pharmacy\
](http://uic.edu/pharmacy)[University of Leeds, United
Kingdom](http://www.leeds.ac.uk/healthcare/teach/pharmacy/home1.html)\
[University of Michigan, University Health Services
Pharmacy](http://www.uhs.umich.edu/)\
[University of Montana, School of
Pharmacy](http://www.umt.edu/pharmacy/)\
[University of Nebraska Medical Center, College of
Pharmacy](http://www.unmc.edu/pharmacy/college.html)\
[University of North Carolina, School of
Pharmacy](http://www.pharmacy.unc.edu/)\
[University of Southern California, School of
Pharmacy](http://www.usc.edu/hsc/pharmacy/index.html)\
[University of Texas at Austin, College of
Pharmacy](http://www.utexas.edu/pharmacy/)\
[University of the Pacific School of Pharmacy and Health
Sciences](http://www.uop.edu/pharmacy/index.html)\
[University of the Sciences in Philadelphia, College of
Pharmacy](http://www.usip.edu/)\
[University of Wyoming, School of
Pharmacy](http://www.uwyo.edu/pharmacy/pharmacy.htm)\
[Washington State University, College of
Pharmacy](http://www.pharmacy.wsu.edu/)\
[Wayne State University, College of
Pharmacy](http://wizard.pharm.wayne.edu/)\
[West Virginia University, School of
Pharmacy](http://www.hsc.wvu.edu/sop/)\
[Yale - New Haven Hospital, Dept. of Pharmacy](http://www.ynhh.org/)

[**Government Agencies and\
Non-Government Standard Setting Organizations**]{.underline}\
[Administration on Aging]()\
[Agency for Healthcare Research and Quality](http://www.ahrq.gov/)\*+\
[California State Board of Pharmacy](http://www.pharmacy.ca.gov/)\
[Drug Enforcement Agency](http://www.usdoj.gov/dea)\
[Food and Drug Administration](http://www.fda.gov/) \*+\
[Health Resources and Services
Administration](http://bphc.hrsa.gov/opa), Pharmacy Affairs\
[Maryland Board of Pharmacy](http://www.mdbop.com/)\
[Massachusetts Legislative Committee on Health
Care](http://www.senatormoore.com/)\
[Missouri Board of Pharmacy](http://www.ecodev.state.mo.us/pr/pharmacy)\
[National Association of Boards of Pharmacy](http://www.nabp.net/)\
[National Digestive Diseases Information
Clearinghouse](http://www.niddk.nih.gov/health/digest/nddic.htm)\
North Dakota State Board of Pharmacy\
[Office of Personnel Management](http://www.opm.gov/insure/index.html)\
[United States Pharmacopeia](http://www.usp.org/)\*+

\* Represented on NCPIE\'s [Board of
Directors](http://www.talkaboutrx.org/about.html#boardofdirectors)

\*+ Nonvoting, liaison member, NCPIE Board of Directors