May 18, 2001 (Washington) -- A controversial plan to offer popular allergy prescriptions for sale over the counter has divided consumer groups.
The issue is whether the unprecedented proposal would make three nonsedating antihistamines available more cheaply or simply shift the costs away from insurance companies that are currently shouldering much of the expense.
"This certainly looks like a test case, if you look at it. The parties have expended a whole lot of resources trying to do this, and I don't know that anyone's going to plow through behind them until they see what happens with this one," says Janell Duncan, legislative counsel for Consumers Union, publisher of Consumer Reports.
The ball is now in the FDA's court following a strong recommendation from an advisory panel earlier this month to allow Schering-Plough's Claritin, Pfizer's Zyrtec, and Aventis' Allegra to be sold without a prescription.
What was particularly surprising was that the initiating action came not from a drug company but as a result of a petition from WellPoint/Blue Cross. There has never been a case where the FDA has been asked to go against the wishes of a drug company and make a prescription available over the counter.
"It's different in that there's a third party and that there are three products being discussed, but then it's really still FDA's work, and I don't think that at this stage it would be different," FDA spokeswoman Laura Bradbard tells WebMD.
WellPoint, meanwhile, had become increasingly concerned about escalating drug costs being absorbed by its 10 million policyholders who take these popular medications. The company characterized the panel's action as a step toward empowering the estimated 40 million Americans who suffer from allergies.
"I think it's a misnomer to say that drugs will be more expensive. There will be no increase in cost," WellPoint's chief pharmacy officer, Robert Seidman, PharmD, MPH tells WebMD.
Although the Families USA consumer advocacy group has often found itself at odds with the insurance industry, it's going along with the idea of selling these allergy drugs without a prescription. "For those people who are uninsured [some 43 million] ... and don't have any insurance coverage for prescription drugs, this actually would be a beneficial thing," Families USA executive director Ron Pollack tells WebMD.
That's because, Pollack says, patients won't have to get a prescription from a doctor, and ultimately the price will come way down. He cites Canada, where such a prescription might cost $75 from a doctor vs. $13 to purchase it over the counter.
He does see a problem, though, for the 40 million poor people covered by Medicaid, many of whom will lose drug coverage with nothing to replace it. Still, Pollack looks at the advisory panel move as an overall plus.
Meanwhile, the pharmaceutical companies warn that even though the newer drugs won't make you sleepy, they encourage self-diagnosis and treatment for complex, related conditions like asthma.
"We disagree with the [panel's] decision," says Schering-Plough spokeswoman Denise Foy. She says she looks at the cost question from another point of view.
"It's hard to imagine that a product with a superior safety profile is going to be priced lower than what's currently on the market," Foy tells WebMD. She points out that the average insurance co-payment is $15 dollars, while a month's supply of maximum-strength Benadryl is around $60.
Larry Sasich, PharmD, research analyst for the health watchdog group Public Citizen, agrees the consumer isn't likely to see a cost benefit from an over-the-counter switch.
"This is really poor healthcare policy where the object seems to be shifting as much of the cost back to the consumer. ... Just because a drug goes from 'Rx' to over-the-counter status doesn't mean that you're going to see some bargain basement prices," Sasich tells WebMD.
For instance, he says, baldness drugs and nicotine gum remained costly after they came off prescription status.
Another issue, says Sasich, is whether customers would be encouraged to buy a more expensive nonprescription antihistamine, when the old ones work just fine for many.
"I think the astounding sales of these three antihistamines are not so much to them being particularly therapeutic agents. I think it's more a matter of promotion than anything else," says Sasich.
Claritin, the No. 1 seller in this category, brings in about $3.6 billion in sales annually in the U.S. The drug manufacturers have all but threatened to sue FDA if they decide to move the drugs over the counter.
While the agency has the authority to take the action, a well-placed source speaking on condition of anonymity tells WebMD, it might well be tied up in court for years, until the patents on the drugs expire. If the drugs were forced out of prescription status, the companies might pull them off the market because of liability concerns that could arise out of unexpected side effects.