WASHINGTON -- Supermarket retailers may be welcoming Tagamet, a popular prescription medication, to their over-the-counter shelves as early as August.
Tagamet, manufactured by SmithKline Beecham, Pittsburgh, took a big step toward OTC status when a Food and Drug Administration advisory committee approved it for over-the-counter sale late last month. The prescription ulcer drug will be marketed in a low-dosage form for the treatment of heartburn.
The next step for Tagamet is to secure FDA approval. The agency typically accepts advisory committee recommendations, but isn't obligated to do so. Supermarket executives polled by SN agreed they expect FDA will give Tagamet the green light to go OTC, and added they will aggressively promote the product, which sold $600 million in prescription form in the United States in 1993, according to trade reports.
There is no timetable for when the FDA will make its decision on the application, an agency spokeswoman said.
But Susan Lavine-Coleman, managing partner at NCI Consulting, Princeton, N.J., and an OTC expert, said she would not be surprised if an OTC version of Tagamet hits supermarket shelves by August or September.
"FDA is very likely to give [Tagamet] approval and wouldn't have persisted in holding a third advisory committee if they were disinclined to approve the product. Only in rare cases does the decision take a long time," she said. Coleman predicted an FDA decision within three months.
Regardless of time frame, some industry experts are predicting Tagamet will be an even
bigger supermarket OTC product than Aleve, an analgesic that made a huge splash at food stores when it debuted last June.
"Tagamet will represent a whole new category for over-the-counter," said Dana Greenhoe, pharmacy director for the 50 pharmacies of Kash n' Karry Food Stores, Tampa, Fla. "The market for Tagamet is probably a little bigger than for Aleve. It's a strong player. Tagamet will be an interesting product when it hits."
Barrett Moravec, director of pharmacy at Abco Foods, Phoenix, said his chain will "start planning for Tagamet right now. It'll be another terrific addition to OTC."
Allen Karpe, director of HBC-pharmacy at Valu Food, Baltimore, agreed Tagamet may promise greater dollar volume than Aleve "because [Tagamet] represents a new category and that opens up totally new revenues for us."
Tagamet differs from current heartburn remedies on the market because it reduces stomach acid instead of neutralizing it. The drug will be marketed as Tagamet HB for heartburn.
Moravec said he believes many consumers will consider Tagamet similar to other antacids because they all provide the same result -- relief from heartburn. The OTC version of Tagamet, though, may find additional life by attracting its prescription users who have ulcers, said Moravec.
"Consumers are very well educated and, eventually, I think people who use [prescription Tagamet] with ulcers will figure out the OTC product is very similar, just a lower dose," said Moravec. "It'll do well, particularly with people who know they have a hiatal hernia."
Tagamet's application for OTC approval had been rejected by FDA advisory committees twice before because of concerns over how it might interact with other medication. In giving its approval March 27, the committee stipulated Tagamet must carry a prominent warning that it shouldn't be mixed with medications promoting blood thinning or treating chronic lung disorders and seizures. Tagamet, in reducing acid levels, makes these drugs more potent. The committee's approval of Tagamet is only for 100-milligram pills, with a dosage not to exceed 200 milligrams, half the dosage prescribed for Tagamet ulcer treatments. Still pending before the FDA for OTC status approval are Tagamet's competitors, Pepcid, marketed by Merck & Co. and Johnson & Johnson, and Zantac, marketed by Glaxo Inc. Last fall Pepcid received provisional approval from an FDA advisory committee, but its final approval by the agency is contingent on further studies of the drug. The FDA spokeswoman said she couldn't comment on when either application might be weighed by the agency. With the advisory committee's recommendation, it appears Tagamet has a head start on Pepcid and Zantac on getting to the market first, said supermarket pharmacy directors. They agreed Tagamet's possible vanguard status may give it an advantage over its competitors.
Coleman of NCI agreed Tagamet has great potential because of its early approval and also because it is a new category of heartburn relief that shouldn't gain the bulk of its share by cutting into current OTC products.
"Tagamet has very high brand name recognition and should spur incremental volume," she said. But, Coleman warned, grocery retailers must use strong early merchandising followed by sustained support in order to make the most of Tagamet.
Food store executives agreed they cannot afford to miss out on being among the first in their markets to have Tagamet HB in stock.
"We'll have it first and at the lowest price," said Karpe of Valu Food, who explained that a retailer's introductory price on a product like Tagamet will set a tone for consumers who may purchase the product again in the future. Therefore, he said, it is essential to have the lowest retail in the initial stages of the product's introduction.
Greenhoe of Kash n' Karry said, "Supermarkets used to be very slow getting switches into the system, but now are getting better on initial introductions. With Aleve, though, supermarkets recognized it would be a big product and I'm sure they'll do the same with this one. We'll get on Tagamet a lot faster. The market potential of a product like this forces us to respond more quickly than on a product that might not have that kind of market size."
Moravec added he doesn't think there will be "a return to old ways for supermarkets. The people working in our marketing departments are on top of new OTC switches, and there's a whole new generation of thinking and doing things differently." Meanwhile, another FDA advisory panel has given its approval for children's Motrin to be sold over the counter. The ibuprofin is marketed by McNeil Consumer Products.
