Over-the-Counter Sale of Allergy Drug Approved

The Food and Drug Administration on Wednesday approved over-the-counter sales of the drug Claritin, clearing the way for allergy sufferers to buy the popular antihistamine without a doctor’s prescription as soon as next month.

The FDA action will directly benefit consumers -- particularly those with no health insurance and those whose insurance does not cover prescription drugs.

A month’s supply of Claritin sold over the counter will probably cost less than $20, industry experts said, and generic versions are likely to be even less expensive. A Claritin prescription now costs $60 or more.

Perhaps even more significant, however, the government’s decision could signal a new phase in efforts to control health-care spending, one that pits the insurance industry against pharmaceutical manufacturers.

The decision “sets an important precedent for all of us striving to protect the affordability of prescription drugs,” said Robert Seidman, chief pharmacy officer of WellPoint Health Networks, the Thousand Oaks-based insurer that first petitioned the government about Claritin’s status.

WellPoint, whose 13 million members include 6 million in California, spent more than $40 million on Claritin prescriptions last year. On top of that, WellPoint members spent $15 to $17 in co-payments for each prescription.

Prescription drug spending is, at roughly 16% a year, the fastest-growing component of overall health-care costs. Brand-name drug manufacturers have strongly resisted congressional and regulatory efforts to make medications more affordable.

More than 41 million Americans have no health coverage, and rising health costs -- including double-digit premium increases that are being passed from insurer to employer to employee -- are likely to leave even more Americans uninsured, experts say.

Claritin was introduced in 1993 as a medication that could relieve sneezing, runny noses and other allergy symptoms without causing drowsiness.

Its manufacturer, Schering-Plough Corp., marketed Claritin as a major advance in allergy treatment, and it soon became the company’s top-selling drug.

By 2000, only eight other drugs were prescribed more often than Claritin, and only two -- the anti-inflammatory Vioxx and the anti-ulcer Prilosec -- were marketed more heavily.

WellPoint officials have for years monitored drug use very carefully, Seidman said, because “we have a responsibility to provide broad access to affordable health care.”

In 1998, the insurer became the first non-pharmaceutical concern to petition the FDA to change the status of a drug.

WellPoint also asked the agency to make not only Claritin but also the antihistamines Allegra and Zyrtec available over the counter.

While those so-called second-generation antihistamines account for as much as 7% of all U.S. spending on prescription drugs, WellPoint officials argued that the drugs clearly met the FDA’s standards for over-the-counter sales.

Federal regulations require that drugs that are sold over the counter must treat a condition that patients can diagnose and manage themselves.

The drugs must also be safe for a consumer to use without medical supervision, and they must have labels that clearly explain what side effects the drugs might have and how they should be taken.

In a vote last year, an FDA advisory committee agreed with WellPoint that all three drugs met these standards.

But the agency took no action until Wednesday. And even then, it acted only on Claritin, and officials stressed that the decision was related not to the petition from WellPoint but to an application made by Schering-Plough.

The drug manufacturer, whose U.S. sales of Claritin totaled $2.7 billion last year, initially resisted the WellPoint petition.

But in February, Schering-Plough won FDA approval of Clarinex, a drug it is marketing as even better than Claritin because it can treat symptoms caused by indoor, as well as outdoor, allergens.

In March, Schering-Plough announced that it was “pushing FDA to move Claritin to over-the-counter,” company spokesman William O’Donnell said Wednesday.

The company’s patent on Claritin expires Dec. 19.

There is no timetable for the FDA to decide whether Allegra and Zyrtec should be made available over the counter, Dr. Robert Meyer, the agency’s director on nonprescription drug evaluations, said Wednesday.

But Aventis, the maker of Allegra, said Wednesday that it was “working to expand its range of new formulations and potential uses” of the drug.