Return to Transcripts main page

CNN Live Today

FDA Discusses Making Claritin Over the Counter Drug

Aired April 22, 2002 - 14:31   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.
KYRA PHILLIPS, CNN ANCHOR: If you're an allergy sufferer, you'll be interested in what federal Food and Drug Administration is up to today. CNN medical correspondent, Rea Blakey, is following talks on whether the popular prescription remedy Claritin should become available over-the-counter. She's in our Washington bureau once again -- Rea.

REA BLAKEY, CNN MEDICAL CORRESPONDENT: Kyra, despite a handful of lucrative drug patents, including one that doesn't expire until 2012, the makers of Claritin are asking an FDA advisory panel for a recommendation to make that blockbuster prescription allergy medication an OTC, or over-the-counter drug.

That should eventually mean cheaper prices for consumers. There are an estimated 45 million U.S. allergy sufferers. And seasonal allergies alone rack up an estimated $4.5 billion each year in medications and doctor's visits.

Now, what the makers of Claritin are seeking is a voluntarily reclassification that would be rolled out in phases. The first phase, under way today before the FDA panel, is to introduce over-the-counter Claritin for the treatment of hives. The official clinical diagnosis is CIU for short.

(BEGIN VIDEO CLIP)

DR. FRANK DAVIDOFF, FDA ADVISORY PANEL: To summarize, the extensive worldwide experience with Claritin supports the appropriateness of this drug for OTC use, based on both RX experience for CIU as well as OTC experience for hives.

(END VIDEO CLIP)

BLAKEY: Now, the FDA would have to review any recommendations made by the panel before OTC approval is granted. The non- prescription drug would be the same as today's current prescription medication. Still, there's no way the manufacturer can keep consumers from using an over-the-counter Claritin that's labeled for hives from being used for allergy relief.

(BEGIN VIDEO CLIP)

DAVIDOFF: It seems to me here that your data rather elegantly demonstrates that, before the diagnosis is made, the great majority, at least the majority of the population, either don't read the labels or they don't understand them or they don't believe them, because they don't follow them.

(END VIDEO CLIP)

BLAKEY: The rollout of an over-the-counter Claritin specifically labeled for allergy relief is likely to come by the FDA by late November, if not much sooner. Schering Plough's voluntary reclassification of Claritin could beat down annual sales revenue from more than $2 billion last year to just $500 million next year.

Claritin is already sold over-the-counter for allergy relief in 33 countries. Our Canadian neighbors, Kyra, pay about $11 a month for their supply.

PHILLIPS: Now, what is this Clarinex that you were talking about a couple of hours ago?

BLAKEY: It's actually a slightly different formulation. And it would be, we're told, the only medication that would be available by prescription, which is where Schering Plough does not lose their market niche. But for indoor allergies as well as seasonal allergies, so it's a slightly different formulation. But it also keeps that market share readily available for the company. Hopefully, they're saying, they won't lose too many more consumers based on the fact that they'll have a great deal of competition when it comes to Claritin being on the market over-the-counter from generic drug manufacturers.

PHILLIPS: All right. Got to keep it straight. Rea Blakey, thank you so much.

TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com