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NEW YORK — The world's top-selling drug may become available over the counter, if its manufacturer has its way, according to published reports.
The New York Times reported that Pfizer may be looking for Food and Drug Administration approval for an OTC switch for Lipitor (atorvastatin calcium), a cholesterol-lowering medication. The Times quoted an unnamed source as providing the information, though Pfizer declined to comment.
Lipitor is the world's top-selling drug, with annual sales of more than $7 billion in the United States alone, according to IMS Health. But it's set to lose patent protection this year and face competition from cheaper generic versions. An OTC switch would allow Pfizer to continue profiting from the drug even if sales of the prescription version took a dip.
But the going won't be easy. While Rx-to-OTC switches for drugs to treat allergies and heartburn generally have been successful, switches for statins haven't been. In 2008, the FDA declined to allow an OTC switch for Merck's Mevacor Daily (lovastatin) due to issues with patient self-selection that emerged during clinical trials; some patients taking prescription-strength statins had reported that they would be willing to switch to the weaker Mevacor Daily, thus putting themselves at risk of being inadequately protected against heart disease. Other patients had misconceptions about Mevacor Daily, thinking it would be more appropriate because it was cheaper and that it would have fewer side effects, with half of patients already taking a statin saying they would switch to OTC Mevacor due to cost concerns.