SPOKESMAN: It's another beautiful day; don't lose it to seasonal allergies. Take control.
SUSAN DENTZER: At least in part due to commercials like this one Claritin and other so-called non-sedating antihistamines have become some of the best-selling prescription drugs on the market. With the springtime allergy season in full swing these drugs are once again in heavy demand. They're not more effective in relieving allergy symptoms than older antihistamines like Benadryl, but they're popular in part because they produce fewer side effects like drowsiness or dizziness, and with as many as 40 million Americans affected by allergies, demand is growing. As a result, the top three non-sedating drugs, Claritin, Allegra, and Zyrtec, had sales of more than $4 billion last year in the U.S. alone.
DR. ROBERT SEIDMAN, Wellpoint Health Networks: People are demanding these medications because they are seeing the commercials on TV; they're seeing the commercials in the print media, having these drugs available over-the-counter will decrease their financial burden and increase their access to these drugs.
SUSAN DENTZER: Dr. Robert Seidman is head of pharmacy operations at Wellpoint Health Networks, a large California-based health insurer. He's now leading an unprecedented charge to convert these three drugs from prescription only to over-the-counter status, known as OTC. That means the drugs would be available without prescriptions in pharmacies, supermarkets or other stores, just like older allergy medications are now. And that could have a profound effect on the drug's manufacturers. Dr. Francois Nader is with Aventis, the company that makes Allegra.
DR. FRANCOIS NADER, U.S. Medical Director, Aventis: This is uncharted waters - you know -- at this stage -- it's premature. It is frankly unnecessary. It is inappropriate, and it might be risky.
SUSAN DENTZER: Wellpoint's bid is rapidly developing into one of the most contentious drug policy disputes in memory. It was the subject of a lengthy hearing today before a committee of scientists and physicians advising the Federal Food & Drug Administration.
SPOKESMAN: So we're here to talk about the safety experience of three different drugs sold under the brand names of Claritin, Zyrtec, and Allegra.
SUSAN DENTZER: Wellpoint's petition represents a sharp break from standard practice. Usually, it's the pharmaceutical company that asks the FDA to convert its drug to over the counter status - sometimes just before the patent on the drug expires. But in this case it's the company paying the bills for the drug rather than the manufacturer that's making the request, and it's at a time when at least two of the drugs, Allegra and Zyrtec, have at least a decade to go on their patents. Seidman of Wellpoint says safety is precisely the reason the drug should be switched.
DR. ROBERT SEIDMAN: Claritin, Allegra, and Zyrtec are safer and equally effective to the complement of over-the-counter anti-histamines that are available today such as Benadryl that cause sedation, sleepiness, and can impair your thinking.
SUSAN DENTZER: Seidman says it simply doesn't make sense to force patients to go to their doctors and obtain prescriptions for the safer drugs when the less safe ones are more freely available. But Wellpoint is also candid about another reason for its petition - the growing costs of the non-sedating drugs. Seidman says those costs are often far lower in other countries. There the drugs are either sold over the counter or they can be purchased after consumers have a quick consultation with a pharmacist.
DR. ROBERT SEIDMAN: The average retail price for a drug like Claritin is $85 a month in the United States, whereas, in Canada, where it's been over the counter for 12 years, the average cost for a month's supply of Claritin is between $11 and $15.
SUSAN DENTZER: Seidman says consumers and insurers alike are paying the price at a time when drug costs are soaring. Both would save money, he says, if the drugs became OTC.
DR. ROBERT SEIDMAN: We believe that we will save approximately $45 million in drug costs and that members will save approximately $45 million in copays, deductibles associated with office visits.
SUSAN DENTZER: But as attractive as the prospect of cheaper and safer drugs seems, many allergists are alarmed. Dr. Michael Kaliner is a leading allergy expert who's also a paid consultant to drug companies. He says allergies are far more serious and complex diseases than usually thought and that in regulatory parlance a learned intermediary like a physician should be part of the treatment process. That wouldn't happen if the drugs were switched to over the counter.
DR. MICHAEL KALINER, Washington Hospital Center: I think that it'll take the physician out of the loop. Allergies - I see patients all day long who think they have allergies but, in fact, have sinusitis or, in fact, have non-allergic rhinitis, and some of them have asthma, and so physicians would no longer be in the loop of seeing these rhinitis patients or many of them, anyway.
SUSAN DENTZER: Drug industry analysts say it's unclear what a shift to OTC would really mean for the drug companies, but those companies are still anxious to head off the change for fear that it would set a precedent for other types of drugs.
DR. FRANCOIS NADER: The major driver behind this petition for Wellpoint is money, and time will say this is the only drug that they have on their radar screen.
SUSAN DENTZER: And at today's hearing Dr. Robert Spiegel of Schering Plough, which makes Claritin, stressed the potential of unknown risks to patients.
DR. ROBERT SPIEGEL, Schering Plough: The fact that such a switch will immediately affect tens of millions of patients should be of concern and requires careful thought, more study, and certainly more data than has been provided to date.
SUSAN DENTZER: But this afternoon the advisory panel disagreed. It voted overwhelmingly that the safety profile of all three drugs was such that they could be converted to over the counter. The FDA will now talk up the committee's recommendation and make a final decision about the switch.