From: GOppel@senior.org
Sent: Wednesday, June 06, 2001 4:55 PM
To: fdadockets@oc.fda.gov
Subject: 98P-0610



(Embedded image moved to file: pic00041.pcx)

May 10, 2001

Sandra Titus
Health Science Administrator
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
5630 Fishers Lane
Mail Stop HFD-21, Room 1093
Rockville, MD 20857

Dear Ms. Titus:

The Seniors Coalition (TSC), on behalf of its four million members
nationwide, would like to register its opinion regarding tomorrow's joint
meeting of the Nonprescription Drugs Advisory Committee and the
Pulmonary-Allergy Drugs Advisory Committee to discuss a Citizen Petition
submitted by Blue Cross of California requesting that the Food and Drug
Administration (FDA) convert several nonsedating antihistamines to
over-the-counter (OTC) status. The Seniors Coalition believes that
reclassifying nonsedating antihistamines will compromise patient safety and
counteract the purpose of insurance coverage, which is to guard patients
from the high costs of medical care.

Seniors are counted among the millions of Americans that suffer from
allergies. Despite public perception, many allergies constitute serious
medical conditions that can be life threatening. Accordingly, allergy
sufferers often must see a trained physician for a proper evaluation of
their symptoms and the prescribing of an appropriate mode of treatment. In
many cases, physicians prescribe nonsedating antihistamines to alleviate,
and sometimes eliminate, a patient's symptoms. The FDA, in its power to
assess the safety and efficacy of all drugs, has determined that all the
nonsedating antihistamines available on the market are to be prescription
drugs, and in effect controlled substances. Reclassifying these drugs as
OTC flies in the face of the FDA's original determination that these drugs
cannot, and should not, be dispensed to patients without a doctor's
evaluation and signature. It follows that, given the inherent dangers posed
by the improper use of prescription drugs, patients should not be free to
self-medicate. TSC fears that seniors, a population that tends to take
numerous drugs simultaneously, will be even more susceptible to adverse
drug interactions if this class of drugs is reclassified as OTC.

Furthermore, reclassifying nonsedating antihistamines as OTC would not be
consumer-friendly. As do other Americans, seniors rely on their health
insurance plans to cover a majority of the cost of their prescription drug
expenditures. The seniors that do have prescription drug coverage through
former employers, Medicare HMOs, Medicaid, state-sponsored low-income
plans, and other sources are responsible for a nominal co-pay ranging from
$5 to $20 per prescription. If the

FDA decides to meet the terms of Blue Cross of California's Citizen
Petition, it will in effect discontinue insurance coverage for the
reclassified drugs. This would not be a problem but for the fact that the
OTC cost of the various nonsedating antihistamines would be much more than
a nominal co-pay. In a time when seniors are already having trouble
affording their medicines, TSC is concerned that seniors would be paying
substantially more out-of-pocket for these important drug treatments.

Ostensibly, the impetus behind Blue Cross of California's Citizen Petition
is to cut costs. But Blue Cross of California is ignoring the fact that,
according to the National Bureau of Economic Research, every $1 spent on
prescription drugs is associated with a decrease of $4 in other health care
expenses. These nonsedating antihistamines are reducing the need for more
expensive medical attention ? such as a hospital stay ? that can result
from a serious allergic reaction. Is it good policy on the FDA's part to
open the door to cost-cutting that will only bring short-term savings?
Moreover, should such cost-cutting be allowed to occur at the expense of
patient safety?

There is no compelling health or economic reason for the FDA to meet the
terms of Blue Cross of California's Citizen Petition. Moreover, TSC is very
concerned that reclassifying these drugs will set a dangerous precedent
that could further erode patient safety and financial security. Therefore,
TSC strongly recommends to the joint meeting of the Nonprescription Drugs
Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee to
reject this Citizen Petition on behalf of the safety and financial
well-being of seniors and other Americans.

Sincerely,

(Embedded image moved to file: pic18467.pcx)
Mary M. Martin
Chairman of the Board
Executive Director