Pfizer has not yet determined whether the US Food and Drug Administration (FDA) would allow the drug to be sold without a prescription. To tackle this issue, the company has assembled a team of experts to examine the feasibility of a switch to OTC sales, as well as other options for the medicine. Selling an OTC version of the drug without a prescription would allow Pfizer to retain some of the US$11 billion in annual revenue that Lipitor has been generating.

The company would first have to convince the FDA that consumers could take the drug without a doctor's supervision. Prescription-to-OTC switches, however, have been rare in recent years, but some have been commercially successful, including Johnson & Johnson's (JNJ; New Brunswick, NJ, USA) launch of an OTC version of allergy drug Zyrtec after Pfizer's prescription version lost patent protection, as well as the Merck (Whitehouse Station, NJ, USA) allergy pill Claritin, which it inherited through its acquisition of Schering-Plough.

“In order to sell Lipitor without a prescription, Pfizer must show that patients can safely diagnose themselves and use the drug properly; no cholesterol-lowering drug, or statin, has been able to do that,” said Shelly Burgess, a spokeswoman for the FDA. “They would have to provide data to show that consumers understand the treatment and recognize that cholesterol monitoring is required. In previous studies most study participants made mistakes and chose to take the proposed over-the-counter statin when they should not have done that.”

Lipitor, the trade name of atorvastatin, is a member of the drug class known as statins, used for lowering blood cholesterol; like all statins, it works by inhibiting HMG-CoA reductase, an enzyme found in liver tissue that plays a key role in production of cholesterol in the body. Lipitor also stabilizes plaque and prevents strokes through anti-inflammatory and other mechanisms.

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