To make matters worse, shortly after the FDA approved over-the-counter sales of Claritin, many health insurers reduced or eliminated coverage for other commonly prescribed allergy medications -- including Zyrtec, Allegra and Clarinex. HMO End Run at the FDA

Allergy season came a little earlier and is a little more severe for most sufferers this year.  With millions of sniffling, sneezing, sinus-clogged Americans grabbing for their tissues, a proposal under consideration by the U.S. Food and Drug Administration (FDA) may have them reaching for their wallets.

In an unprecedented move, WellPoint Health Networks, one of the nation's largest health care companies, has petitioned the FDA to move the popular prescription allergy drugs Allegra, Zyrtec and Clarinex (a successor to Claritin) to over-the-counter status.  While proponents claim such a move would benefit consumers, in reality, it's the health insurance companies (HMOs) that stand to gain most.

When Claritin recently became available without a prescription, the health insurance industry and the companies they cover were licking their chops over the nearly $1 billion in prescription cost savings they'll enjoy each year.  As for allergy sufferers, instead of a $15 to $20 co-payment to be diagnosed and prescribed the medication, they now have to pay around $1 per pill for over-the-counter Claritin, which adds up to hundreds of dollars per allergy season.  While this plan is one heck of a deal for the HMOs, it perhaps can best be described as a whopping tax increase on average Americans with allergies. 

To make matters worse, shortly after the FDA approved over-the-counter sales of Claritin last year, many health insurers reduced or eliminated coverage for other commonly prescribed allergy medications -- including Zyrtec, Allegra and Clarinex -- or increased the prescription co-payment on those drugs, to induce consumers to buy Claritin out of their own pockets.  According to The New York Times, WellPoint alone has saved roughly $90 million by shifting the cost of Claritin from employee health plans directly to consumers. 

In addition to the overwhelming financial implications of the FDA's proposal, there are also exceptionally high costs in terms of the health and safety of American consumers.

The process of prescription drugs being moved to over-the-counter status, most commonly near the end of their patent exclusivity, has always been a slow waltz between the FDA and drug manufacturers, with many well-choreographed steps, including a careful examination of the sometimes significant consumer safety issues involved in such a move.  The health insurers -- led by WellPoint -- are clumsily seeking to butt-in to that dance by petitioning the FDA to switch the status of these medications based on the insurers' timetables, without their own determination of the drugs' safety and efficacy for self-medication, and without the input of the drugs' manufacturers. 

The American Academy of Asthma, Allergy & Immunology has strongly opposed the WellPoint proposal, arguing that the increased direct costs to patients will make these drugs less accessible.  Those consumers who can afford them will be less likely to visit a doctor to receive a proper diagnosis regarding their allergy suffering, and will be more likely to overuse or misuse these drugs, resulting in increased health care costs. 

As Dr. Lawrence DuBuske of Brigham and Women's Hospital, who is an educator of physicians in asthma and allergy, wrote to the FDA:  "It is unreasonable to expect that the public will be able to manage their allergic disease more appropriately than physicians trained in such disease management."

Take the hypothetical example of a consumer who at the first sign of nasal congestion self prescribes one of these powerful new over-the-counter drugs.  After weeks of continued suffering, the individual finally succumbs to being examined by a doctor, only to learn that a severe sinus infection is at the root of the problem.

The WellPoint proposal has received preliminary approval from an advisory panel of experts at the FDA, and according to The New York Times, FDA Commissioner Mark McClellan will consider it "very seriously" if legal and practical complications can be ironed out.  Perhaps he's referring to the almost certain constitutional challenges that will be filed by drug companies over the plan's violations of their patents and the Fifth Amendment's Takings Clause. 

The WellPoint plan is a blatantly self-serving attempt by the health insurance industry to defray its costs of commonly prescribed drugs.  If approved, life will get a whole lot more miserable for chronic allergy sufferers, and a dangerous precedent will be set for other commonly prescribed, and costly, drugs.

May 22, 2003
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