Pfizer Wants Atorvastatin Available Over the Counter

August 04, 2011

August 4, 2011 (New York, New York)— Pfizer is hoping to sell atorvastatin (Lipitor) to consumers over the counter (OTC) as a way to offset the expected plunge in revenue as the world's best-selling prescription drug goes off patent in November, according to the Wall Street Journal [1].

The switch from an $11-billion/year drug juggernaut to an OTC medication won't be easy for Pfizer, however, as the Food and Drug Administration has turned Merck away multiple times, including its most recent effort in 2008, when it made similar pitches to have lovastatin (Mevacor) available to consumers without a prescription. Bristol-Myers Squibb was also denied when it made a push to have pravastatin (Pravachol) available OTC.

As reported by heartwire previously, the FDA is concerned that patients might not be able to determine whether they are candidates for statin therapy without direction from a physician. As a result, high-risk patients might be undertreated with the OTC statin, while low-risk patients might take the drug unnecessarily.

Wall Street Journal reporter Peter Loftus notes that a switch to OTC status for atorvastatin would not happen until the drug has already gone off patent in the US. The company would need to convince the FDA that consumers can follow the instructions on the label and make an informed decision about whether they should take the lipid-lowering medication. However, the deck is not stacked in the company's favor, according to experts.

"The statin switch is a difficult one, and the arguments against the switch . . . have not [gone] and will not go away," Patrick Ronan, a former chief of staff at the FDA, told the Journal. Dr Brian Strom (University of Pennsylvania School of Medicine, Philadelphia) said he does not believe it would be wise to change atorvastatin from prescription to OTC, given that patients taking statins require periodic blood tests to determine the impact of therapy on cholesterol levels. Patients taking the OTC medication might not receive these tests, he said.

Still, despite the uphill battle, Loftus reports that Pfizer held onto its consumer healthcare unit, the division responsible for sales of OTC medicines, even as it sells off other divisions. "The main reason Pfizer wants to keep its consumer unit is the opportunity to market OTC versions of some drugs Pfizer currently sells as prescription-only," writes Loftus.

Pfizer did not confirm or deny the plans. Raymond Kerins, a spokesperson for Pfizer, told the New York Times that that company has "strategic plans in place for Lipitor’s loss of exclusivity and will comment no further at this time" [2].

In 2004, the UK approved a 10-mg dose of simvastatin for OTC sale.

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