WellPoint Health to the FDA: Make Rx allergy drugs OTC

If you think that a pharmaceutical company is the only concern that can petition the Food & Drug Administration to switch a prescription drug to over-the-counter status, think again. WellPoint Health Networks, Thousand Oaks, Calif., has filed a citizen's petition with the FDA to switch three Rx allergy drugs—Claritin (loratadine, Schering-Plough), Allegra (fexofenadine, Aventis), and Zyrtec (cetirizine HCl, Pfizer)—to over-the-counter status.

Noting that WellPoint Health Networks' expenditures for covering allergy drugs range from $30 million to $50 million a year, Robert Seidman, WellPoint's v.p. of pharmacy, told Drug Topics, "We are looking at the escalating cost associated with providing an Rx drug benefit and the need and responsibility to provide access to essential medications at a reasonable price."

Seidman said that in 1998 he was astounded by the substantial costs involved in covering the cough and cold/decongestant/ antihistamine classes of drugs. "I looked at my numbers and said, 'I can't believe we're spending so much money on these classes of drugs and these drugs are safer than the agents you can get without an Rx.' A light bulb went off in my head to convert Rxs to OTC status."

Seidman said WellPoint Health Networks provided the FDA with clinical data showing that the three allergy Rxs are safer than OTC allergy medications. The company is planning to work with a university to provide the FDA with "a full complement of peer-reviewed articles comparing these nonsedating antihistamines with OTC agents. The issue here is, Why should the health-care system stand in front of an individual's access to these clearly safe and efficacious products?" he said. He also noted that patients shouldn't have to waste time and money for physician visits to obtain Rxs for drugs that are safe enough to use as OTCs. "The direct-to-consumer ads on TV even state the side effects are similar to taking a sugar pill," he observed.

Seidman said if the allergy drugs were to be switched to OTC, pharmacists would "have the opportunity to use their professional training for counseling and assisting patients to choose safer alternatives."

While the FDA has not acted on the petition, the agency recently announced that it will hold a public meeting later this month in Gaithersburg, Md., "to solicit information from interested persons—including scientists, professional groups, and consumers—and to discuss the agency's approach to regulating over-the-counter drugs." Issues to be addressed include the classes of drugs that should or should not be available OTC, consumer understanding of the benefits and risks of such access to drugs, and the FDA's role in changing drugs from Rx to OTC status.

Seidman said the meeting is encouraging in light of the fact that "we received a Dear Rob letter from the FDA in January of 1999 that said, 'Don't call us, we'll call you.'"

Comments on WellPoint Health Networks' petition were offered by Steve Francesco, president, Francesco International, a South Orange, N.J.-based international consulting firm specializing in Rx-to-OTC switches. "The whole issue is to take these drugs off [payers'] reimbursement rolls," he said. "Wellpoint is trying to save money. The firm's argument is that allergy products, specifically Claritin, are safe and nonsedating. Most allergies are not life-threatening, and [these firms] are tired of paying what they are paying. Having a third party, in this case a reimbursement system, submit a switch petition is kind of unheard of. That doesn't mean it shouldn't be done," he said.

Francesco said that although the process of petitioning the FDA is costly because of the clinical studies involved, the savings accrued by insurers would be substantial. While the FDA hasn't yet responded to the petition, which "is under review," an FDA spokeswoman said that "it is unlikely the sponsor [manufacturer] could be forced to pursue an indication it doesn't already have in its labeling."

Peter Flatow, president of CoKnowledge, a market research firm in Southport, Conn., said that while the United States continues to move Rx drugs over the counter, the nation trails other countries in doing so. He views the upcoming FDA meeting as promising and said, "The guardianship the FDA has had on consumers is becoming more realistic, as well it should."

Corinne Russell, a spokeswoman at the Consumer Healthcare Products Association, told Drug Topics that her organization "has a long and established history of supporting consumers' rights to self-medicate. The single most promising aspect of self-medication today is the trend of switching proven prescription drugs to over-the-counter status."

By Allergy Treatment