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Some related articles :

Three Generic-Drug Makers To Create a Cheaper Prilosec (November 1, 2002)

Prilosec's Maker Switches Users To Nexium, Thwarting Generics (June 6, 2002)

Federal Panel Backs Prilosec
For Over-the-Counter Sales

By Jill Caroll
 The Wall Street Journal, June 22, 2002

A federal advisory panel's recommendation that the Food and Drug Administration allow over-the-counter sales of Prilosec, the prescription heartburn drug, came with strong reservations about the drug's proposed labeling.

The panel of medical experts said AstraZeneca PLC's blockbuster drug should be sold as a once-a-day medicine taken for a two-week period to prevent frequent heartburn, but the advisers said the proposed label wasn't written clearly enough to ensure that consumers will use Prilosec properly.

"I'm very concerned about the label as written," said Nancy Geller, a member of the panel, echoing other panel members' concerns. "I think it's written in poor English. It's redundant and needs to be redone." The panel cited several examples that drew snickers from the audience, including this warning: "Notify your doctor if you have had heartburn for three months or longer without talking to your doctor."

"It's not a surprise at all the committee would want us to have clear labeling that consumers can understand," said Greg Allgood, a spokesman for Procter & Gamble Co., of Cincinnati, which would market the drug. Mr. Allgood said he expected the FDA to issue a final decision by summer's end, and by then, the labeling concerns will be addressed.

The FDA generally follows the recommendations of its advisory panels.

Prilosec was once the world's top-selling drug, peaking at $6.3 billion in 2000. P&G estimates total sales of the over-the-counter version could reach as much as $400 million a year. If the agency approves the drug for store shelves, the company expects to start selling it by year-end or early 2003. The OTC designation would help cushion the fall in revenues expected when generic versions of Prilosec, whose patent has expired, come to market. London-based AstraZeneca has been fighting generic incursions in the courts.

Analysts don't expect pharmaceutical houses to push other blockbuster drugs for over-the-counter sales anytime soon. Hemant Shah, an industry analyst with HKS & Co., Warren, N.J., said the FDA is likely to remove the prescription requirement only for drugs that treat short-term problems. As a result, many of today's big-selling drugs -- such as cholesterol reducers, which people need to take indefinitely -- aren't likely to end up on store shelves, Mr. Shah said. Also, any drug with the potential to be abused or cause significant side effects is unlikely to go OTC.

An over-the-counter Prilosec would pose a challenge to the current king of non-prescription heartburn medicines, Pepcid, made by Johnson & Johnson-Merck Consumer Pharmaceuticals Co. The joint venture of Johnson & Johnson and Merck & Co. has said it doesn't anticipate losing business to Prilosec because Pepcid offers immediate heartburn relief.

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