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*1001 Connecticut Ave., NW, Suite 1128, Washington, DC 20036 Phone:
202-467-5809*

July 11, 2003

Dockets Management Branch

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20857

Re: Response to Citizen Petition Requesting that Certain Prescription
Allergy Medication Be Switched to OTC Status

Docket No. 98P-0610/CP

**Introduction**

Consumer Alert is submitting these comments on the Citizen Petition
cited above filed by Blue Cross of California Pharmacy (now WellPoint
Health Networks). That petition asks the Food and Drug Administration to
mandate a switch to over-the-counter status for the prescription drugs
Allegra/Allegra-D, Claritin/Claritin/Claritin-D, and Zyrtec.[^1]

**Interest of the Commenter**

Consumer Alert, established in 1977, is a national non-profit consumer
group. Its mission is two-fold -- to work on public policy issues
affecting consumers and to provide consumer educational materials on
topical issues. Its positions are based on the belief that a market
economy benefits consumers by increasing choice and competition, which
can lead to lower prices and advances in technology to improve health
and safety. Consumer Alert is dedicated to the principles of free
enterprise and limited government.

Consumer Alert has an extensive body of work relating to the Food and
Drug Administration and its regulation of pharmaceutical drugs, where
the organization emphasizes consumer access to beneficial drugs and
truthful information. For example, the organization has been involved
with the issues of drug and device approval lag, off-label use, and the
FDA\'s restrictions on advertising information to consumers. On
direct-to-consumer advertising, Consumer Alert filed a petition with the
FDA to allow that information. CA and CEI filed a petition to overturn
the FDA's so-called "pediatric rule," which would bar physicians from
prescribing some medicines to children absent specific pediatric tests.
CA and CEI were joined in the filing by the American Association of
Physicians and Surgeons.

**Consumer Alert's Position on the Petition**

Consumer Alert is opposed to the granting of this petition for the
following reasons:

-   The petition is essentially requesting FDA to make a determination
    based primarily on economic considerations, not scientific ones.
    That goes well beyond the mission of the agency and would seriously
    detract from the FDA's primary function as a health and safety
    regulator. WellPoint's interest in the resolution of the issue is
    primarily an economic one: as an insurer, with a shift to OTC status
    of the drugs, the insurer would not have to pay for coverage. The
    FDA should not intervene in what is a dispute pitting one industry
    sector against another. Neither is it the mission of the FDA to take
    on that role nor does the agency have the expertise to make such
    economic determinations.

-   The petitioner WellPoint is taking upon itself a role for which the
    manufacturers of drugs have responsibility. Essentially, WellPoint
    is saying that the prescription-only status of the drugs at issue is
    in error -- that they are safe to be distributed over the counter
    and asks FDA to concur in its opinion. Consumer Alert would offer
    that manufacturers are in a better position to request changes to
    the status of prescription drugs. They are the entities that will
    bear responsibility for any adverse events that may occur when
    formerly prescription drugs provided under a physician's care are
    opened to wider use in the general population. Presumably, consumers
    benefit from the manufacturer, rather than an outsider, initiating
    such a change. With the possibility of monetary loss and/or
    liability claims if adverse events occur, manufacturers are likely
    to be somewhat cautious in changing prescription drugs to OTC
    status. Those disincentives act as deterrents to introducing or
    distributing unsafe products; they do not apply to WellPoint as a
    third-party.

-   FDA should evaluate its own role in this petition, even in having
    its scientific Advisory Committee evaluate whether the drugs are
    safe to be dispensed without prescription. Having a committee make
    such a determination [over the objections of the drugs'
    manufacturers]{.underline} would seem to be unprecedented and would
    not necessarily be in consumers' interests.

-   For FDA, that type of decision also seems to be in conflict with the
    agency's role of balancing the need for the streamlined introduction
    of new drugs with careful review of safety considerations. In this
    instance, the FDA would be saying that the manufacturer's own
    concerns about potential safety risks if the drugs are distributed
    OTC should be discounted. That does not seem to be its position when
    evaluating prescription drugs, where new products are subject to
    rigorous examination for their safety and efficacy, and where some
    potentially life-saving medications face unduly lengthy approval
    processes. In that context, if a manufacturer stated, for example,
    that it wasn't confident that its drug should be dispensed widely,
    one would expect great weight to be given that evaluation. An FDA
    decision upholding this petition would paint the agency as having
    "One foot on the brake pedal, the other on the gas" and would not
    necessarily provide consumers with a sense of consistency of FDA's
    actions.

-   If the petition prevails, and these drugs are "forced" to be changed
    to OTC drugs, consumers would not necessarily be better off in their
    pocketbooks. Many who currently are prescribed these medications and
    have insurance plans to offset some of the costs may face higher
    out-of-pocket costs, as the OTC drugs would not be covered by
    insurance plans. Again, Consumer Alert reiterates, FDA should not
    get in the middle of economic and pricing issues that are better
    left to the market.

-   Consumer Alert would like to make clear that the organization does
    not question the general ability of consumers to make their
    decisions about use of OTC drugs, to read enclosed material on doses
    and warnings, and to follow instructions. OTC medications have
    helped millions of consumers treat their conditions and illnesses
    and lead healthier lives. What the organization is questioning is
    turning on its head a process that has worked in consumers'
    interest.

Consumer Alert would recommend that the FDA deny the petition as not
being in the interests of consumers.

Sincerely,

Frances B. Smith

Executive Director

[^1]: The manufacturer of Claritin has subsequently voluntarily switched
    that drug to OTC distribution status.