Pfizer Inc. wants to introduce a version of its popular cholesterol pill Lipitor that consumers could buy without a doctor's prescription, according to people familiar with the matter.
The effort, if successful, could help Pfizer squeeze new sales life out of the world's best-selling drug in the years after Lipitor loses U.S. patent protection in November, which will trigger sales-eroding generic competition that will eat into Lipitor's current yearly haul of nearly $11 billion.
But Pfizer likely faces an uphill battle because the U.S. Food and Drug Administration has previously rejected the idea of allowing over-the-counter versions of cholesterol drugs in the same class as Lipitor—known as statins—because of concerns that consumers aren't able to properly use the drugs without a doctor's guidance.
FDA spokeswoman Shelly Burgess said prior research on proposed over-the-counter statins hasn't proven that most consumers will make correct decisions about taking the drugs. But she said the agency is open to discussing OTC statins, as long as companies are ready to demonstrate that consumers will make the right decisions.
Pfizer hopes regulators may now be more open to the idea, as budget-strapped governments in the U.S. and Europe are looking for ways to control rising health-care costs—and encouraging wider use of low-cost OTC drugs might fit the bill. Lipitor currently sells for about $4 to $5 per pill at retail, while an OTC version would likely sell for substantially less.
Some public-health experts also have argued that increasing the accessibility to statins in the form of nonprescription versions could prevent more heart attacks and strokes across the population, sparing greater health-care costs to treat those conditions.
A nonprescription version of the cholesterol drug simvastatin is available for sale in U.K. pharmacies, though it is sold "behind the counter," not on store shelves, requiring interaction with pharmacists.
Any switch to over-the-counter status for Lipitor won't happen in time to be available immediately after the U.S. patent protection for the prescription version expires in November, according to the people familiar with the matter. Pfizer first needs to conduct additional research to convince the FDA that consumers can properly follow label instructions for taking an OTC version of Lipitor.
"The statin switch is a difficult one and the arguments against the switch ... have not and will not go away," said Patrick Ronan, a former chief of staff at the FDA who now provides regulatory consulting services to health-care companies.
Pfizer recently decided to hold onto its consumer health-care unit, which sells over-the-counter medicines including Advil and Robitussin, even as it pursues divestitures of other divisions including animal health. 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.
Prescription-to-OTC switches have been rare in recent years, but some have been commercially successful, including Johnson & Johnson's launch of an over-the-counter version of allergy drug Zyrtec after Pfizer's prescription version lost patent protection, as well as Merck & Co.'s allergy pill Claritin, which it inherited through its acquisition of Schering-Plough.
Merck's Claritin OTC generated $401 million in sales for 2010. In comparison, annual sales of the prescription version of Claritin once exceeded $3 billion before the drug lost U.S. patent protection nearly a decade ago.
"If you can keep some of that [market], that's a win, especially a drug as big as Lipitor," said Les Funtleyder, a Miller Tabak health-care portfolio manager .
But statins, which can prevent heart attacks and strokes by controlling cholesterol levels, have faced a tougher road to the pharmacy aisle in the U.S.
The FDA rejected several attempts by Merck, most recently in 2008, to introduce a nonprescription version of the statin Mevacor. An FDA advisory panel voted against the application, concluding that a significant number of consumers would be unable to make correct decisions about whether to take the drug, and that their cholesterol levels wouldn't be sufficiently monitored outside the care of a doctor.
One study of an OTC Mevacor showed that 30% of patients who thought they should take the drug actually had less than a 5% risk of a heart attack or other cardiovascular event in the next 10 years, and were therefore unlikely to benefit, according to a 2008 article in the New England Journal of Medicine written by the chairwoman of the FDA advisory committee.
Many patients who thought they should take OTC Mevacor were outside the proposed target population of men over 45 and women over 55 who had high levels of bad cholesterol and met other criteria, the committee found.
When a drug is unlikely to provide benefit, its known side effects become a greater concern. Though Lipitor is relatively safe, it is not supposed to be used by anyone with liver disease, nor by pregnant women or nursing mothers, and has been linked to adverse events including muscle weakness.
What's more, some experts have drawn a distinction between current OTC drugs such as allergy pills and OTC statins. Allergy drugs provide symptomatic relief, so consumers are generally equipped to judge when to take them, and for how long. But statins treat an asymptomatic condition—poor cholesterol levels—so patients aren't in a good position to decide whether they should take them, and whether they are providing a benefit, some medical exports say.
"I do not think it would be wise," said Brian Strom, a professor of public health and preventive medicine at the University of Pennsylvania School of Medicine. He said patients taking statins should have periodic blood tests to gauge the impact on cholesterol levels, and people taking over-the-counter versions might not get those tests.
Plus, he added, patients tend to perceive over-the-counter drugs as less "serious" than prescription drugs, and thus may not take them in accordance with the label instructions.
The effort, if successful, could help Pfizer squeeze new sales life out of the world's best-selling drug in the years after Lipitor loses U.S. patent protection in November, which will trigger sales-eroding generic competition that will eat into Lipitor's current yearly haul of nearly $11 billion.
But Pfizer likely faces an uphill battle because the U.S. Food and Drug Administration has previously rejected the idea of allowing over-the-counter versions of cholesterol drugs in the same class as Lipitor—known as statins—because of concerns that consumers aren't able to properly use the drugs without a doctor's guidance.
FDA spokeswoman Shelly Burgess said prior research on proposed over-the-counter statins hasn't proven that most consumers will make correct decisions about taking the drugs. But she said the agency is open to discussing OTC statins, as long as companies are ready to demonstrate that consumers will make the right decisions.
Pfizer hopes regulators may now be more open to the idea, as budget-strapped governments in the U.S. and Europe are looking for ways to control rising health-care costs—and encouraging wider use of low-cost OTC drugs might fit the bill. Lipitor currently sells for about $4 to $5 per pill at retail, while an OTC version would likely sell for substantially less.
Some public-health experts also have argued that increasing the accessibility to statins in the form of nonprescription versions could prevent more heart attacks and strokes across the population, sparing greater health-care costs to treat those conditions.
A nonprescription version of the cholesterol drug simvastatin is available for sale in U.K. pharmacies, though it is sold "behind the counter," not on store shelves, requiring interaction with pharmacists.
Any switch to over-the-counter status for Lipitor won't happen in time to be available immediately after the U.S. patent protection for the prescription version expires in November, according to the people familiar with the matter. Pfizer first needs to conduct additional research to convince the FDA that consumers can properly follow label instructions for taking an OTC version of Lipitor.
"The statin switch is a difficult one and the arguments against the switch ... have not and will not go away," said Patrick Ronan, a former chief of staff at the FDA who now provides regulatory consulting services to health-care companies.
Pfizer recently decided to hold onto its consumer health-care unit, which sells over-the-counter medicines including Advil and Robitussin, even as it pursues divestitures of other divisions including animal health. 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.
Prescription-to-OTC switches have been rare in recent years, but some have been commercially successful, including Johnson & Johnson's launch of an over-the-counter version of allergy drug Zyrtec after Pfizer's prescription version lost patent protection, as well as Merck & Co.'s allergy pill Claritin, which it inherited through its acquisition of Schering-Plough.
Merck's Claritin OTC generated $401 million in sales for 2010. In comparison, annual sales of the prescription version of Claritin once exceeded $3 billion before the drug lost U.S. patent protection nearly a decade ago.
"If you can keep some of that [market], that's a win, especially a drug as big as Lipitor," said Les Funtleyder, a Miller Tabak health-care portfolio manager .
But statins, which can prevent heart attacks and strokes by controlling cholesterol levels, have faced a tougher road to the pharmacy aisle in the U.S.
The FDA rejected several attempts by Merck, most recently in 2008, to introduce a nonprescription version of the statin Mevacor. An FDA advisory panel voted against the application, concluding that a significant number of consumers would be unable to make correct decisions about whether to take the drug, and that their cholesterol levels wouldn't be sufficiently monitored outside the care of a doctor.
One study of an OTC Mevacor showed that 30% of patients who thought they should take the drug actually had less than a 5% risk of a heart attack or other cardiovascular event in the next 10 years, and were therefore unlikely to benefit, according to a 2008 article in the New England Journal of Medicine written by the chairwoman of the FDA advisory committee.
Many patients who thought they should take OTC Mevacor were outside the proposed target population of men over 45 and women over 55 who had high levels of bad cholesterol and met other criteria, the committee found.
When a drug is unlikely to provide benefit, its known side effects become a greater concern. Though Lipitor is relatively safe, it is not supposed to be used by anyone with liver disease, nor by pregnant women or nursing mothers, and has been linked to adverse events including muscle weakness.
What's more, some experts have drawn a distinction between current OTC drugs such as allergy pills and OTC statins. Allergy drugs provide symptomatic relief, so consumers are generally equipped to judge when to take them, and for how long. But statins treat an asymptomatic condition—poor cholesterol levels—so patients aren't in a good position to decide whether they should take them, and whether they are providing a benefit, some medical exports say.
"I do not think it would be wise," said Brian Strom, a professor of public health and preventive medicine at the University of Pennsylvania School of Medicine. He said patients taking statins should have periodic blood tests to gauge the impact on cholesterol levels, and people taking over-the-counter versions might not get those tests.
Plus, he added, patients tend to perceive over-the-counter drugs as less "serious" than prescription drugs, and thus may not take them in accordance with the label instructions.