Pfizer Inc., the world’s biggest drugmaker, is studying whether its Lipitor cholesterol pill can be sold as an over-the-counter medicine, according to a person familiar with the discussions.
The company hasn’t determined whether the U.S. Food and Drug Administration would allow the drug to be sold without a prescription, the person said. Pfizer has assembled a team to examine the feasibility of a switch to over-the-counter sales, as well as other options for the medicine, said the person, who asked not to be named because the deliberations are private.
Lipitor, the best-selling drug in the world with $10.7 billion in sales last year, loses U.S. patent exclusivity in November. Previous attempts to sell over-the-counter versions of cholesterol-lowering drugs, including Merck & Co.’s Mevacor and Zocor, were unsuccessful because of the side effects. Patients using Lipitor need regular tests of their cholesterol and liver functioning, according to the drug’s label.
“There is no reason to think that somehow where Mevacor and Zocor failed, Lipitor would be successful,” David Maris, an analyst with CLSA in New York, said in an e-mail. “This also would not be a savings to consumers, just to insurance companies, managed-care plans and the government,” he said.
MacKay Jimeson, a spokesman for New York-based Pfizer, declined to comment on the company’s plans to pursue an over-the-counter version of Lipitor.
“We can confirm that we have strategic plans in place for Lipitor’s loss of exclusivity,” Jimeson said.
Pfizer gained 13 cents to $17.49 at 4 p.m. in New York Stock Exchange composite trading. The drugmaker has gained 8 percent in the past 12 months.
In order to sell Lipitor without a prescription, Pfizer must show that patients can safely diagnose themselves and use the drug properly, said Shelly Burgess, a spokeswoman for the FDA. No cholesterol-lowering drug, or statin, has been able to do that, she said.
“They would have to provide data to show that consumers understand the treatment and recognize that cholesterol-monitoring is required,” Burgess said. 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.”
Drugs with U.S. sales of more than $1 billion a year typically lose 73 percent of revenue in the first three months after generic copies are introduced, according to an analysis by Bloomberg Industries. Pfizer successfully took its allergy medicine, Zyrtec, over-the-counter in 2008 before selling its consumer unit that year to Johnson & Johnson for $16.6 billion.
Pfizer last month completed a review of four business units for possible sale or divesture. The company decided to keep the consumer unit that it gained in the 2009 acquisition of Wyeth and its established products unit, which makes generic drugs and branded versions of drugs with expired patents. The company said it plans to sell its animal health and baby formula units.