FDA Approves Over-The-Counter Sale of Prescription Allergy Drug Claritin

The FDA last Wednesday approved over-the-counter sales of the prescription allergy drug Claritin, which will allow consumers to purchase the medication without a prescription and for a lower price, the New York Times reports. Over-the-counter Claritin, which analysts said likely will cost about $30 per month instead of $85 per month for the prescription version, will be available as early as the middle of December. Schering-Plough officials did not say how much the company planned to charge for the medication (Petersen, New York Times, 11/28). Health insurer WellPoint, which was spending more than $40 million a year on Claritin, petitioned the FDA in 1998 to make the drug, as well as the allergy drugs Allegra and Zyrtec, available over-the-counter. An FDA committee last year said that all three allergy medications, which account for as much as 7% of all U.S. prescription drug spending, were safe to use without medical supervision and that package labels "clearly" explained the drugs' side effects and dosage, the Los Angeles Times reports. However, the FDA thus far only has approved over-the-counter sales of Claritin. The Times reports that the agency's decision was related to an application filed by Schering-Plough, which "initially resisted" the switch. In February, the company won FDA approval for Clarinex, a once-a-day version of Claritin, which the drug maker is marketing as "even better" than Claritin because it can treat both indoor and outdoor allergies. In March, company officials said they were "pushing FDA to move Claritin over-the-counter." According to Dr. Robert Meyer, the FDA's director of nonprescription drug evaluations, the agency has no timeframe for its decision on over-the-counter sales of Allegra and Zyrtec.

According to the Times, over-the-counter Claritin will "directly benefit consumers," particularly those without health insurance and those without prescription drug coverage (Kemper, Los Angeles Times, 11/28). However, patients with insurance will pay more for the medication because their health plans will no longer cover it (New York Times, 11/28). The Washington Post reports that the decision to sell Claritin over-the-counter could have "profound ramifications" because many insurers likely will "swiftly push" allergy patients to buy over-the-counter Claritin instead of more expensive allergy treatments such as Allegra and Zyrtec. Further, the decision could "set a powerful precedent" as insurers may urge other medications, such as acid reflux drugs, to be sold over-the-counter as a way to "pass on" the cost of prescription drugs to consumers, according to the Post (Vedantam, Washington Post, 11/28). NPR's "All Things Considered" Wednesday reported on the FDA approval (Prakash, "All Things Considered," NPR, 11/27). The full segment is available in RealPlayer Audio online.