FDA advisers say three drugs should go over the counter
Advertiser Staff and News Services
WASHINGTON — The popular allergy drugs Claritin, Allegra and Zyrtec should be made available without a prescription, a Food and Drug Administration advisory panel recommended yesterday, endorsing an unprecedented request by an insurance company over the objections of the drugs' makers.
The recommendation to reclassify the drugs, made at the panel's meeting in Gaithersburg, Md., represented a setback for the pharmaceutical industry, which opposed the switch and has threatened to sue the FDA if it follows the recommendation, which it usually does. Agency officials did not predict when a final decision would be made.
While in theory this change will make the drugs more readily available, the move could have several negative effects, including driving prices up for those already on the medications, and encouraging patients to take drugs that may not be right for them, say physicians and insurance executives.
"Now people have to go to the doctor to get those drugs, which brings them in to an allergist so they can be put on the right thing," said Dr. Stuart Rusnak, a Honolulu asthma and allergy specialist. "But if people self-medicate, they don't get a medical workup. And a lot of people are treating themselves with stuff they shouldn't be on."
The other major impact would be that insurance plans would be unlikely to cover costs of these drugs.
"Most drug plans don't cover over-the-counter medications," said Roy Yamauchi, manager of pharmacy benefits for the Hawai'i Medical Service Association, which provides medical coverage for most of the Hawai'i market. "It would be an exception to current policy to pay for this."
However, Yamauchi said that if health plans no longer pay for the allergy drugs — about $73 for instance, for a month's supply of the popular allergy medication Claritin — drug companies might be forced to price them more competitively.
WellPoint Health Networks of Thousand Oaks., Calif., prompted the FDA panel's action with its first-of-a-kind petition, arguing the drugs were safe enough to be made available over the counter. If successful, the insurer would save about $45 million a year because it only covers prescription drugs.
Schering-Plough, Aventis SA and Pfizer Corp., which make the three drugs, argued the medicines have not been on the market long enough to know whether they can be used safely by consumers without oversight by a doctor. At stake for the manufacturers are billions of dollars. Last year, the three heavily promoted drugs generated $4.7 billion in combined sales.
In Hawai'i, HMSA recently raised rates 9 percent — the biggest jump in eight years — blaming rising drug costs as one of the major reasons. In the past 10 years, said Yamauchi, the cost of drugs has gone from about 8 percent to 17 percent of the total spent by HMSA. For those three allergy drugs alone, HMSA paid out $3.7 million last year, said Yamauchi.
The clash between representatives of the two biggest players in the U.S. health-care system — insurance and pharmaceutical companies — highlights increasing friction between insurers worried about the rising costs of prescription medications and drug companies trying to recoup the costs of developing new medicines.
"If the FDA agrees to these switches, the changes discussed today will be the tip of the iceberg," warned Bert Spilker a senior vice president of the Pharmaceutical Research and Manufacturers Association, the main lobbying arm of the industry. "It is likely that many products will be proposed for such changes of status on a very frequent basis by those who have a strong self-interest in the change."
Said Robert Seidman, chief pharmacist for WellPoint: "These companies know when the drugs are made available over-the-counter they will have to price them comparatively. They are attempting to instill a significant amount of fear."
Never before has the FDA reclassified a drug over manufacturer objections, and officials were reluctant yesterday to speculate on its ability to force a switch.
"This is a new paradigm," said John Jenkins, director of the FDA's office of drug evaluation.
However, industry analysts suggested that if the FDA declares the three antihistamines safe for widespread distribution, it would be difficult for the drug companies to continue limiting access to prescription-only customers.
During a daylong hearing, drug company representatives argued that additional research is needed before determining if patients can accurately diagnose and treat allergies without a doctor's input. Although Pfizer did not participate in the hearing, industry sources said the pharmaceutical giant opposed the switch.
Calling the petition "premature," Francois Nader, senior vice president of medical and regulatory affairs at Aventis, warned that a switch is "inappropriate, unnecessary and potentially adverse" to public safety.
But the 23-member FDA advisory panel grew increasingly skeptical of those assertions. "Can you give me an example of a specific safety concern you are pursuing?" Alastair Wood of Vanderbilt University School of Medicine asked at one point.
Seidman pointed out that Claritin is sold safely over the counter in Canada, for about $11 a month.
Aside from safety concerns, the drugmakers warned of bleak consequences for the industry if the drugs were rushed into wider distribution.
Slashing costs could hurt future drug development, said Ivor Emanuel, an ear, nose and throat specialist connected to Pharmacia Diagnostics. "If you don't recapture some of that investment, we won't get any new drugs."
Spilker warned that if the FDA moves forward it would "chill many areas of research and development."
Andrea Apter, a panel member and associate professor at the Hospital of the University of Pennsylvania, expressed concerns about access to the drugs for the low- and moderate-income clients who now rely on insurance coverage.
"That situation applies to everything we review" for over-the-counter switches, said Charles Ganley, director of the FDA's division of over-the-counter drugs. If that were the criteria, "nothing will ever get taken to over-the-counter."
In the end, the panel voted 19-4 to recommend switching the status of Claritin and Zyrtec, and voted 18-5 for changing Allegra's status.
Advertiser staff writer Beverly Creamer contributed to this report.
