MONDAY, May 14 (HealthScout) -- Whether three highly popular allergy drugs should be made available without a prescription soon could become more of a legal and economic issue than a medical one.
Late Friday, a government panel recommended that the Food and Drug Administration reclassify the drugs Claritin, Allegra and Zyrtec from prescription-only to over-the-counter status.
In doing so, the panel sided not with the drugs' manufacturers, all of whom oppose such a switch, but with the health insurance company that had instigated the request.
WellPoint Health Networks, which operates as Blue Cross in California and Georgia and as UNICARE elsewhere in the United States, says the three widely prescribed antihistamines work as well as drugs long available without a prescription but with fewer side effects. Adding these three products to pharmacy shelves, the company says, would "empower the 40 million Americans who suffer from allergies."
Others, however, think differently.
"The whole brouhaha [over safety and accessibility] is a nonissue," says pharmacist Larry Sasich, a research associate on drug issues with Public Citizen Health Research Group, a consumer research and advocacy group in Washington, D.C., founded by Ralph Nader.
"It's really economics," Sasich says. "The public should be able to tell from this exactly what happens when bottom lines begin to look bad."
"The for-profit health insurance industry is trying to improve its bottom line by shifting the burden for as much of the cost as possible to the consumer," he says.
Spending on prescription drugs in the United States increased 84 percent from 1993 to 1998, according to a study released last summer by the National Institute for Health Care Management Research and Education Foundation.
Leading the pack -- with a 612 percent increase -- was spending on oral antihistamines like the three drugs now in the spotlight, the study says.
WellPoint alone has said it would save approximately $45 million a year if the drugs became non-prescription. Insurance plans almost never cover the cost of over-the-counter medications.
But beyond economics, the legal issue is even more interesting, Sasich says.
"We don't believe the FDA has the authority to compel the manufacturer of a patented drug to make the application and do the research" needed to change a drug to over-the-counter status, he says.
If it tried to do this, he says, "you would see the FDA instantly in court."
The drug manufacturers themselves have all but threatened legal action should the FDA side with the advisory panel.
Claritin manufacturer Schering-Plough, in a statement issued Friday, says such action "would constitute an unprecedented departure from past agency policy and implicate the [drug makers'] statutory and constitutional rights."
Historically, it has been the domain of the drug makers to decide when, or even whether, a drug gets switched from prescription to nonprescription status.
Plenty of drugs have made the leap from prescription-only to over-the-counter. Among antihistamines, Benadryl and Chlortrimeton, for instance, changed about a decade ago, joining dozens of brands and dosage combinations available to consumers plagued by allergies.
However, most over-the counter antihistamines tend to make their takers drowsy enough so that labels on these products clearly warn of impaired performance and urge people, for instance, not to drive while taking them.
But the three drugs now under consideration -- Claritin, Allegra and Zyrtec, which are called second-generation antihistamines -- were developed specifically to limit this unwelcome side effect. Studies have shown that they elicit about the same sedating effect as a sugar pill.
Many countries already allow Claritin, for instance, to be sold without a prescription. Available first in Belgium in 1988, the drug now is sold in more than 94 countries, including at least 17 where a prescription is not needed.
In Canada, residents have been able to purchase Claritin without a prescription since 1989. A month's supply of pills there reportedly costs between $10 and $15.
In the United States, the drug costs approximately $90 a month. People with prescription-drug coverage usually pay $5 to $15, with the insurance company paying the balance.
WellPoint has predicted that, if Claritin and the other drugs become available without a prescription, the cost to consumers "would be roughly equivalent to the co-pay they are already paying for these drugs," according to a company statement.
Sasich, however, is not so sure.
"We can't tell what they might price [these drugs] as over-the-counter," he says.
For example, he adds, look at what happened when the anti-baldness drug Rogaine and the stop-smoking aid Nicorette chewing gum converted from prescription to non-prescription availability.
"I cannot remember that there was a very significant drop [in price]," Sasich says. "When generic competition came in, there was a little pressure downward, but these are still expensive drugs for over-the-counter products."
Because anyone can purchase an over-the-counter drug, Schering-Plough and the other manufacturers have stressed what they say could be risky self-diagnosis and treatment if a doctor weren't involved.
"We are only beginning to understand the complexity of allergic diseases and their relationship to other diseases," the company says in a statement. "Suboptimal treatment of allergic disease may worsen [coexisting] diseases [like asthma or sinusitis]."
Thinking they have only an allergy problem, in other words, people could miss other serious diseases because they wouldn't see a doctor if they simply could buy pills to treat allergies.
The insurers simply want to "shift costs from third-party payers to allergy sufferers," the company says. "This is likely to have a detrimental impact on access in general and in particular on access for groups that can least afford to pay for medications out-of-pocket."
FDA instructions to the advisory panel asked that group members focus solely on consumers' ability to understand and use these drugs safely without medical intervention. Economic factors, the FDA says, are not the agency's domain.
The FDA traditionally has followed the recommendations of its advisory panels on such issues, but it's not bound to do so.
The agency has not issued a formal statement since the panel voted 19 to 4 to recommend switching Claritin and Zyrtec to non-prescription status and 18-5 to make Allegra available without a prescription. Crystal Rice, a spokeswoman for the FDA's Center for Drug Evaluation and Research, says just when a decision might be reached is not yet known.
"This was an unprecedented move," she says of the health insurer's request to change the status of a drug.
"We honestly aren't sure what to do next," Rice says, "but we're working on it."
What To Do
To learn more about allergies, visit the National Institute of Allergy and Infectious Diseases online.
For more on drugs and safety, try the Institute for Safe Medication Practices or U.S. Pharmacopeia.
Or, you might want to read previous HealthScout articles on allergies.
