Demand for Prilosec OTC outstrips suppliers' projected consumer need

Conspiracy theorists have unearthed their latest pharmaceutical conspiracy in chain drug's aisle of gastrointestinal relief, as accusations have been thrown about that AstraZeneca is artificially shorting Americans of their supply of Prilosec OTC in an effort to funnel heartburn sales to its next-generation proton-pump inhibitor: prescription-only Nexium.

To be sure, it's not too far-fetched to theorize that AstraZeneca has no incentive to step up production of Prilosec OTC, a product the pharmaceutical company sans consumer division has licensed to Procter and Gamble for marketing over-the-counter. There's definitely means and motive, as any fan of television's "Law & Order" or "CSI" would be quick to point out, but the theory just doesn't pan out.

"America's frequent heartburn is much more common than we could have ever predicted," commented Crystal Harrell, a P&G spokeswoman. "We have worked closely with our supplier to try to meet this unprecedented demand for Prilosec OTC."

The sentiment is similar at AstraZeneca. Both companies are making every effort to meet what has been described as a phenomenal demand that neither company foresaw.

And while the public positioning of each company is to be expected, that argument holds plenty of water.

For starters, during the approval process, the switch application for a drug treating the chronic condition of frequent heartburn was never the slam dunk that the nonsedating anthihistamine Claritin was. There was plenty of concern over the appropriateness of switching a medicine that also was one of the first lines of treatment for gastroesophageal reflux disease, a serious gastrointestinal condition that never was considered appropriate for an OTC indication.

At the time, there also was plenty of speculation as to how well Prilosec OTC would sell given the fact it was only supposed to be used for two weeks at a time and only three times per year without the need to consult a physician. As if that wasn't enough, there was conjecture that consumers trying Prilosec OTC for the first time may be disappointed--according to the label, relief of heartburn symptoms may not come for as long as 24 hours. Products for heartburn already on the market worked much faster than that--with immediate relief coming from calcium-containing products like Turns or Rolaids and relief within the hour from H2 blockers like Pepcid AC and Zantac 75.

Taking all of that into consideration, a conservative estimate of expected need may have been considered prudent at the time.

Besides, sales of Prilosec OTC by no means have suffered as a result of the shortage. The brand generated $134.8 million for the 52 weeks ended Jan. 23, eclipsing sales of all private label antacid tablets by $68 million, according to Information Resources Inc. Incremental sales of Prilosec OTC measured $83.4 million--by itself more than double the total sales of any individual gastrointestinal remedy in chain drug. Incidentally, incremental growth for the entire category was measured at $83.6 million for the period, testimony that the demand for Prilosec OTC was a pretty significant factor throughout the entire category.

So even what would have been described as a very aggressive estimate of demand by P&G may have resulted in supply shortages. "All we know is that America's frequent heartburn is much more common than we could have ever predicted, and this unprecedented demand for Prilosec OTC has challenged our supply chain," Harrell reiterated.

Part of that uptick in demand most certainly has been driven by managed care, as third party payers moved the remaining prescription-only PPIs either to higher copay tiers or off their approved formularies altogether. "The goal is to maximize the best value in any of these therapeutic classes," commented Robert Seidman, chief pharmacy officer for WellPoint Health Networks. "There are some health plans that are adding Prilosec OTC to formulary and then requiring a treatment failure or contraindication of Prilosec OTC before a prescription PPI is covered. We're seeing the wonders of the free market, where [companies] are being very creative and coming up with solutions that are designed to protect affordability.

And while P&G cannot market Prilosec OTC as an appropriate treatment for use beyond two weeks, there never was anything that would prevent doctors who had prescribed prescription Prilosec (omeprazole) for years from recommending continuous use for their patients, especially if the cost of Prilosec OTC turned out to be cheaper than generic omeprazole. Likewise, no one can discredit the intelligence and fiscal wherewithal of the average consumer, who may draw little distinction between the 20 mg of a generic omeprazole prescription that a doctor may have prescribed and the 20 mg of omeprazole found in Prilosec OTC. And if that patient did decide to consult a doctor or pharmacist on the subject, there is little more either health care professional could say other than that the medicines were basically the same.

by Michael Johnsen