From: Rxhealthvalue@aol.com
Sent: Monday, May 07, 2001 2:46 PM
To: tittuss@cder.fda.gov
Subject: OTC Anthihistimines Testimony
Sandy,

We spoke a few weeks ago and you invited me, on behalf of our organization to
submit testimony and comments on Wellpoint's petition and the Advisory
Hearing on May 11.  My hope is that we may still be included as offering
testimony in the brief 5 minute segments on May 11.

RxHealthValue is a coalition of consumer groups, health care providers,
labor, employers,  insurers, pharmacy benefit managers and individuals whose
mission is to improve access to health improving drugs.  Members include:
Organizational Members:
AARP,
Academy of Managed CarePharmacy,
AdvancePCS Health Systems, Inc
AFL-CIO,
AFSCME,
Alliance for Community HealthPlans (not-for-profit health plans),
American Academy of Family Physicians,
American Medical GroupAssociation,
Blue Cross/Blue ShieldAssociation (48 Blue Plans),
Caremark Inc.
DaimlerChrysler
FamiliesUSA,
Ford Motor Company,
General Motors,
GTE Corporation,
Kaiser Permanente,
Lahey Clinic,
Managed Health Care Association,
Marriott Corporation
Midwest Business Group onHealth,
National Consumers League,
National Council of SeniorCitizens,
National Institute of HealthCare Management,
Schneider Institute for Health,
Service Employees International Union,
United Automobile Workers,
US West/Verizon
Washington Business Group on Health,


Individual Members

Stuart Altman, Ph.D., BrandeisUniversity;Alain Enthoven,Ph.D., GraduateSchool
of Business, Stanford University Christine K. Cassel, MD, Chair,Department of
Geriatrics, Mt. Sinai Hospital/School of Medicine;Arnold Milstein, MD,
William M.Mercer, Inc., Ira Ockene, MD, University of Massachusetts
MedicalCenter



RxHealthValue supports Wellpoint’s bringing this petition before the FDA and
the FDA acting in a timely manner. As a general policy, RxHealthValue
supports conversion of prescription drugs to OTC only in those cases when :
low side effect profiles,
labeling which is understandable at a reasonable reading level,
the condition is easily diagnosed by the patient and treated with the OTC
     product, and
the use of the product or the medical condition do not require on-going
medical management such as diagnostic procedures,  lab tests or assessments
requiring the technical expertise of a physician
the condition treated is a chronic condition (as opposed to acute)
the benefit/risk ratio is of net benefit to the patient
no potential harm to the patient, and
low potential for misuse and abuse

The experience in Canada, Australia and  New Zealand provides compelling
evidence of years of appropriate understanding and use of 2nd generation
antihistamines based on labeling offered by the manufacturers.  We recommend
that the FDA consider reviewing the post-marketing surveillance data from
these nations.


Please feel free to call with any questions at:

Mark Cloutier MPP MPH
Policy Director
RxHealthValue

625 Indiana Ave. NW, Ste. 200                2322 Sixth St., Ste. 103
Washington DC 20004                            Berkeley, CA  94709

Ph. 202-905-7325
Fax: 801-751-3761

Email: RxHealthValue@aol.com