Pfizer Eyes OTC Lipitor, but Will FDA Approve?

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You can't blame Pfizer (NYS: PFE) for trying to squeeze every last bit of sales from Lipitor. And on the face of it, a bid to move the megablockbuster cholesterol drug over the counter seems logical. OTC launches have helped shore up plenty of off-patent brands. But Merck has been down this road before with Mevacor. Three times.

Both Lipitor and Mevacor are statins, and they are designed to treat high cholesterol, a symptomless condition. The only way patients can discover they have it is through a blood test. And the only way they'd know drug therapy was working would be a follow-up blood test. That's very different from allergies or heartburn, both commonly treated by OTC drugs once available only by prescription. People who use Allegra or Claritin know they're working when they stop sneezing. Prilosec patients stop feeling the telltale burn. And then there's the question of side effects.

An FDA spokesperson tells the Wall Street Journal that the agency is "open" to the idea of OTC statin drugs, provided drugmakers can prove consumers would make the right decisions about using them. At the least, the WSJ points out, Pfizer would have to conduct studies to show that consumers could read the drug label correctly and use the proper dosage.

Merck ran into trouble with that. One study showed that almost one-third of patients who thought they should use Mevacor actually had less than 5% risk of heart attack within 10 years. "The statin switch is a difficult one and the arguments against the switch ... have not and will not go away," Patrick Ronan, a former chief of staff at the FDA, told the WSJ.

As the New York Times notes, an over-the-counter Lipitor would help justify Pfizer's plans to keep its consumer healthcare unit, even as it spins off or sells its animal health and nutritionals businesses. Similarly, a branded-generic version supports the choice to keep its established products business going. Pfizer is already planning to make a generic Lipitor version for sale in the U.S. by Watson Pharmaceuticals; its own generics unit could hawk a branded generic elsewhere.

Pfizer wouldn't say whether the anonymous sources talking OTC Lipitor are correct. "We can confirm that we have strategic plans in place for Lipitor's loss of exclusivity and will comment no further at this time," spokesman Raymond Kerins, Jr. told the NYT.

This article originally published here. Get your free daily pharma briefing here.

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