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FDA Considers Making Claritin Available Over the Counter

Aired April 22, 2002 - 10:44   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
LEON HARRIS, CNN ANCHOR: Put down the tissue and open your ears allergy sufferers. Advisory committees at the Food and Drug Administration begin a two-day hearing today on making the popular allergy prescription Claritin available over the counter. Now, this is not simply a matter of whether the drug is safe enough to do that, but also the financial impact it could have on the competition. Our medical news correspondent is Rea Blakey and she is covering that for us this morning. Hello, Rea.

REA BLAKEY, CNN MEDICAL CORRESPONDENT: Good morning, Leon. Right now, the maker of Claritin is trying to hedge its bets, protect its market share. Schering-Plough is petitioning the Food and Drug Administration to approve the allergy medicine for over the counter use, but there is a catch here. They want to use it to treat hives.

Of course, the bigger question, as you mentioned, is when will Claritin be available without prescription for seasonal allergy treatment? That's still to come. Now what's happened here is there's been an unprecedented move to cut prescription drug costs. A company called WellPoint Health Works in California, an insurance company, petitioned the FDA last year to force the makers of three popular antihistamines to make their allergy medications available over the counter.

Now Schering-Plough is caving under the pressure, announcing it will make Claritin available without prescription. But the company is rolling out its OTC drug in phases. It's the very same formulation of Claritin that's currently sold in the U.S. to treat seasonal allergies. But Schering-Plough wants to capitalize on carving out a new market niche, with the only OTC labeling for the treatment for hives.

Now, of course, as usual, the advisory committee is only recommending a course of action, and it's up to the FDA to approve Claritin for over-the-counter use of hives. But keep in mind, if it's the same Claritin and if it's available for treating hives, then there's no real way the company can keep you or I as consumers from using that product to treat our seasonal allergies, and getting it cheaper than by prescription.

Now, Claritin is already sold over the counter in 33 countries as an allergy remedy. In Canada, for example, a month's supply of Claritin cost about $11, that's again, without a prescription. Compare that to the average of $17 a month as a co-payment for U.S. people who were insured, and also, of course, the doctor's fee that goes along with that. You can realize the savings if you do a little bit of quick math, as WellPoint in California did. They predicted that by Claritin going over the counter alone for seasonal allergies, that company could actually save up to $45 million a year on prescription drug costs -- Leon.

HARRIS: And you add up a couple of $45 million tabs right there, and for a while, you're talking about serious money, as they say.

BLAKEY: Serious cash.

HARRIS: But let me ask you this: How long would it take for this to actually get to a point where we could actually find it in a drugstore somewhere?

BLAKEY: That's questionable. The absolute last moment will probably be late November. That's the FDA's on-paper timeline. But if you're the company, if you're Schering-Plough, you want to try and get this moving as quickly as possible. So this rollout phase for hives in particular could take within the next month or two. It's very likely that shortly after that, they will try and get Claritin on the market over the counter. But keep in mind, they are going to follow up with another prescription version of the basically same medication, called Clarinex, so that they can still try and lock in a prescription, if you will, consumer niche there. And there are other medications that are similar that will probably go through a similar process, unprecedented.

HARRIS: Yes. Well, real quickly there, what's the different between Claritin and Clarinex?

BLAKEY: It'll probably be a few molecules, quite honestly, and of course that prescription price tag that will make a big difference. These companies spend a great deal of money on research and development. They had a 20-year patent and it didn't expire for several more years. So they are going to try and get more run out of the dollars they've already spent.

HARRIS: Business is business. Rea Blakey, thank you very much. Appreciate that.

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