August 4, 2011

Non-Prescription Lipitor May Be Available Soon

US regulators will be considering a plan from pharmaceutical giant Pfizer to introduce an over-the-counter version of its top-selling heart drug Lipitor. Selling the popular anti-cholesterol drug without a prescription could help Pfizer's bottom line as the company faces a "patent cliff" that threatens to erode profits during the next few years, according to the Wall Street Journal.

Lipitor will soon lose patent protection and face competition from cheaper generic versions of its popular prescription medicine in the United States starting in November. Pfizer has already lost exclusive rights to sell the drug in Canada, Spain, Brazil and Mexico.

Overcoming the regulatory hurdles will be difficult. Merck failed three times to win the agency's approval for over-the-counter versions of Mevacor, which, like Lipitor, is a statin. Bristol-Myers Squibb also failed to obtain approval for an over-the-counter version of Pravachol, another statin.

"We can confirm that we have strategic plans in place for Lipitor's loss of exclusivity and will comment no further at this time," Raymond F. Kerins Jr., a spokesman for the company, told the New York Times.

An over-the-counter version of Lipitor would no doubt be welcomed by insurers and patients due to its lower cost. However, in the past, the FDA has been concerned that over-the counter versions of statins could not be used safely, that some patients who did not need the drugs would take them.

People at significant risk of cardiovascular problems might begin taking the over-the-counter drug and forgo seeing a doctor or getting other necessary care. High cholesterol is a symptomless condition and consumers would not know whether the drug was working without having their cholesterol checked periodically.

Steven Francesco of Francesco International, a consulting firm that specializes in converting brand name drugs to over-the-counter products, claims that technology such as prescription cards used at the drug store would better allow patients to be monitored without physician supervision.

"There's any number of ways to insure that the consumer can use the drug," Mr. Francesco told the New York Times. "Lipitor will be one of the first of many drugs that will attempt to switch between now and 2016."


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