Could the blockbuster cholesterol-lowering drug Lipitor soon be available without a prescription?
Pfizer, Lipitor's manufacturer, reportedly wants to sell an over-the-counter version of the drug, according to a source cited in the Wall Street Journal. The Journal article reported that Pfizer hopes to be able to continue profiting off the top-selling drug after its patent expires this November, which leaves other companies free to manufacture generic versions.
Pfizer would neither confirm nor deny the rumor.
"We can confirm that we have strategic plans in place for Lipitor's loss of exclusivity and will comment no further at this time," a company spokesperson said in an email to ABC News.
In the United Kingdom, experts say a drugs like Lipitor and Zocor fall into a third class of medicines that are for sale without a prescription only after a consumer consults with a qualified pharmacist. But in the U.S., drugs are only sold as prescription or directly to the consumer.
If the pharmaceutical giant does have plans in the works for a non-prescription version of Lipitor, it faces a tough challenge in teh U.S. The Food and Drug Administration rejected three separate attempts by Merck and Co. to get its cholesterol-busting drug Mevacor approved for sale without a prescription.
Mevacor and Lipitor are both statins, a class of cholesterol-lowering drugs. Doctors say making Lipitor more accessible could potentially save lives.
"This is probably one of the best ways to reduce the risk of having a heart attack or stroke, and tens of millions of patients could and should be treated," said Dr. Christopher Cannon, associate physician at Brigham and Women's Hospital in Boston.
But other experts say it's difficult to prove that selling these drugs directly to consumers is safe, and there are numerous risks involved in making Lipitor over-the-counter.
"Patients need a blood test to confirm they have high cholesterol, and they need to receive a specific dose of Lipitor that works for them," said Erin Fox, director of the University of Utah's Drug Information Service. "Patients need to be monitored periodically to make sure it's working and not having any side effects, such as liver damage."
Lipitor as a prescription is very safe, Fox added, but Pfizer needs to prove that customers who buy the drug without a prescription can be tested so they can get the right dose and take the drug effectively and safely.
There are also other challenges that Pfizer has to confront. Over-the-counter medicines are supposed to be easy for a consumer of average intelligence to use by reading the instructions on the label.
"The first issue is that the consumer, without any input from a health professional, must know if he or she needs the medication," said Paul Doering, distinguished service professor emeritus at the University of Florida's College of Pharmacy in Gainesville, Fla. The only way to find out about the need for a cholesterol-lowering drug, Doering said, is to have a blood test.
Another problem that could arise, he said, is that people who need Lipitor may not take it because they don't know they need it, while those who don't need it may take it to prevent high cholesterol.
People who take the drug may also erroneously believe that if they do, they can forego healthy lifestyle changes.
"They may believe they can continue high fat foods and unhealthy foods because they wash it down with a Lipitor," Doering added.
Other Drugs Don't Need Close Monitoring
There have been numerous other drugs that were once prescription but were approved for over-the-counter sale, notably Prevacid, Prilosec and very recently, Claritin and Allegra.
"These other drugs don't need to be monitored as closely as Lipitor," Fox said.
Among patients who could benefit the most from a non-prescription version of Lipitor are the uninsured, who would be spared the expense of a doctor's visit. Those with insurance may also benefit, depending on how much they have to pay out of pocket for the drug.
Another insurance situation could arise as well, Doering explained. If a drug is available over-the-counter, insurance companies may refuse to pay for it if a doctor prescribes it, and in some cases, the non-prescription drug price is higher than the out-of-pocket cost.
While Pfizer wouldn't elaborate on the actions it will take after the patent for Lipitor expires, Fox said that so far she hasn't seen any tentative FDA approvals for Pfizer's generic arm, Greenstone, to manufacture a generic form of the drug yet.